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The purpose of this study is to determine if there are differences in cognitive function (thinking) in individuals who have recurrent hypoglycemia (low blood sugars) following Roux-en-Y gastric bypass, compared with individuals who have also had a Roux-en-Y gastric bypass but do not have hypoglycemia.
This study will test the hypothesis that a history of recurrent hypoglycemia following gastric bypass is associated with differences in cognition (thinking), by analyzing results of cognitive testing in post-gastric bypass individuals with a history of hypoglycemia as compared to those without known hypoglycemia.
This pilot study will identify cognitive domains of interest, as well as inform the development of a future battery of assessments, which could be replicated in a larger sample. Cognitive domains which will be assessed include: premorbid intelligence, memory, language, executive function, and psychomotor speed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoglycemia after gastric bypass surgery - post-bariatric hypoglycemia (PBH) | Participants with PBH, recruited from the Joslin Hypoglycemia Clinic and from other hypoglycemia studies at Joslin. |
| |
| Post-gastric bypass participants without a history of hypoglycemia | Participants with a history of Roux-en-Y gastric bypass, but without a diagnosis of hypoglycemia, or symptoms of hypoglycemia, recruited by advertisement flyers at postoperative surgical clinics at local hospitals (such as Brigham and Women's and Beth Israel Deaconess Hospitals), research match, and from other hypoglycemia studies at Joslin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Assessment (not diagnostic) | Other | Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Immediate Verbal Memory | Rey Auditory Verbal Learning Test (RAVLT) immediate recall accuracy scores was used to measure immediate verbal memory. Scores for this assessment were compared between groups. Scores for this assessment range 0 to 69, with a higher score indicating a superior immediate verbal memory. Wilcoxon rank-sum tests was used to examine differences between groups. | During the one day of cognitive assessment administration. |
| Assessment of Delayed Verbal Memory | RAVLT 20 minute recall accuracy scores, was used to measure delayed memory and was compared between groups. Scores for this assessment range 0 to 15, with a higher score indicating less delays in memory. Wilcoxon rank-sum tests was used to examine differences between groups. | During the one day of cognitive assessment administration. |
| Working Memory Assessed by the Letter Number Sequencing Scaled Score | Letter-Number Sequencing subtest from the Wechsler Memory Scale III scaled scores were used to measure working memory and were compared between groups. Wilcoxon rank-sum test was used to examine differences between groups. Scores for this assessment range 1 to 19, with a higher score indicating a superior working memory. | During the one day of cognitive assessment administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Cognitive Flexibility Using Trails Scaled Score | Delis-Kaplan Executive Function System (DKEFS),Trail Making Task score was used to assess the cognitive flexibility component of executive function. Scores are derived from time to complete the task plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive flexibility. |
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Inclusion Criteria:
Exclusion Criteria:
There will be no involvement of special vulnerable populations such as fetuses, neonates, pregnant women, children, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.
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Participants will be recruited into 2 groups: (1) patients with hypoglycemia after upper gastrointestinal surgery (PBH), recruited from the Joslin Hypoglycemia Clinic, (2) asymptomatic post-bariatric patients without hypoglycemia, recruited from postoperative surgical clinics at Brigham and Women's Hospital or Beth Israel Hospitals.
Some participants may be recruited from other hypoglycemia studies at Joslin.
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| Name | Affiliation | Role |
|---|---|---|
| Mary Elizabeth Patti, MD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37667837 | Result | Puleio A, Sheehan A, Musen G, Patti ME. Cognition in patients with post-bariatric hypoglycemia. Obesity (Silver Spring). 2024 Mar;32(3):466-471. doi: 10.1002/oby.23862. Epub 2023 Sep 5. |
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There were plans to include controls (no history of gastric bypass, no hypoglycemia). 3 were recruited and assessed. Upon analysis they did not match age/BMI of the post-bariatric hypoglycemia (PBH) group, and with a low number, were excluded from the design.
3 additional participants were subsequently excluded upon review of history/records: 2 with no history of gastric bypass, and 1 with a traumatic brain injury (revealed upon detailed medical history).
In August of 2020 recruitment began. Potential participants were recruited from the Joslin Diabetes Center hypoglycemia clinic, local advertisement, research match, and through participation in other studies. Recruitment ended August of 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Participants with PBH, recruited from the Joslin Hypoglycemia Clinic and from other hypoglycemia studies at Joslin. Cognitive Assessment (not diagnostic): Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed. ECG: ECG will take place during screening visit. |
| FG001 | Post-gastric Bypass Participants Without a History of Hypoglycemia | Participants with a history of Roux-en-Y gastric bypass, but without a diagnosis of hypoglycemia, or symptoms of hypoglycemia, recruited by advertisement flyers at postoperative surgical clinics at local hospitals (such as Brigham and Women's and Beth Israel Deaconess Hospitals), research match, and from other hypoglycemia studies at Joslin. Cognitive Assessment (not diagnostic): Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed. ECG: ECG will take place during screening visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Participants with PBH, recruited from the Joslin Hypoglycemia Clinic and from other hypoglycemia studies at Joslin. Cognitive Assessment (not diagnostic): Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed. ECG: ECG will take place during screening visit. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Assessment of Immediate Verbal Memory | Rey Auditory Verbal Learning Test (RAVLT) immediate recall accuracy scores was used to measure immediate verbal memory. Scores for this assessment were compared between groups. Scores for this assessment range 0 to 69, with a higher score indicating a superior immediate verbal memory. Wilcoxon rank-sum tests was used to examine differences between groups. | Posted | Median | Standard Deviation | RAVLT scores on a scale (range 0 to 69) | During the one day of cognitive assessment administration. |
|
Adverse event data were collected during the single study visit for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hypoglycemia After Gastric Bypass Surgery - Post-bariatric Hypoglycemia (PBH) | Participants with PBH, recruited from the Joslin Hypoglycemia Clinic and from other hypoglycemia studies at Joslin. Cognitive Assessment (not diagnostic): Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed. ECG: ECG will take place during screening visit. |
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Limitations of this pilot study include its small sample size, cross-sectional approach, and low power (increased risk of type 2 error).
The battery of tests utilized was specifically limited to maintain a total assessment time of no more than one hour, in order to reduce the impact of participant fatigue.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Elizabeth Patti, MD | Joslin Diabetes Center | 6173091966 | MaryElizabeth.Patti@Joslin.Harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 18, 2021 | Apr 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| ECG | Diagnostic Test | ECG will take place during screening visit. |
|
|
| During the one day of cognitive assessment administration. |
| Assessment of Cognitive Flexibility Using Color-word Inference Test | DKEFS Color-Word Interference Test (CWIT) Inhibition Switching scores was used to measure the cognitive flexibility component of executive function. The CWIT is scored by time to complete plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive flexibility. | During the one day of cognitive assessment administration. |
| Assessment of Inhibition Using Color-word Inference Test | DKEFS CWIT scores was used to measure the inhibition component of executive function. The CWIT is scored by time to complete plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior inhibition. | During the one day of cognitive assessment administration. |
| Verbal Ability Cognitive Control Assessed by Letter Fluency | DKEFS Letter Fluency Task will be used to assess the verbal functioning cognitive control ability component of executive function. Scores are derived from the number of unique, correct words. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior verbal functioning cognitive control ability. | During the one day of cognitive assessment administration. |
| Assessment of Psychomotor Speed | The grooved pegboard test is a manipulative dexterity task that assesses psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into holes within the given time limit up to 300 seconds (the score upper limit is thus 300). Time taken to complete the test has been found to be inversely correlated with cognitive ability; therefore, a higher score represents an inferior score. Wilcoxon rank-sum test was used to examine differences between groups. | During the one day of cognitive assessment administration. |
| Verbal Ability Cognitive Control Assessed by Category Fluency | DKEFS Category Fluency scores were used to measure cognitive control of verbal ability, specifically measuring an individuals ability to access and retrieve semantic information (memory) as a component of executive function. Category fluency is scored by number of correct words plus errors in a 60 second trial in each of 3 categories. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability. | During the one day of cognitive assessment administration. |
| Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score | DKEFS Category Switching scores will be used to measure cognitive control of verbal ability, specifically measuring an individuals ability to access and retrieve semantic information (memory), switching back and forth between 2 different semantic categories, a component of executive function. Category switching is scored by number of correct words plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability. | During the one day of cognitive assessment administration. |
| Verbal Ability Cognitive Control of Inhibition, Assessed by Category Switching Accuracy Scaled Score | DKEFS Category Switching Accuracy scores will be used to measure cognitive control of verbal ability, specifically measuring an individuals ability to inhibit incorrect or repetitive semantic information (memory), while switching back and forth between 2 different semantic categories, a component of executive function. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability. | During the one day of cognitive assessment administration. |
| Lexical Processing Assessed by Letter Fluency, First Interval. | DKEFS Letter Fluency, first interval scores will be used to measure cognitive control of lexical processing, specifically measuring an individuals ability to retrieve phonemic information, a component of executive function. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. There are four intervals of this task the first assessing initiation of retrieval while the following trials measuring the ability to sustain retrieval. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of lexical processing. | During one day of cognitive assessement administration. |
| Lexical Processing as Assessed by Letter Fluency, Second Interval | DKEFS Letter Fluency, second interval scores will be used to measure cognitive control of lexical processing, specifically measuring an individuals ability to retrieve phonemic information, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to sustain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of lexical processing. | During one day of cognitive assessement administration. |
| Lexical Processing Assessed by Letter Fluency, Third Interval | DKEFS Letter Fluency, third interval scores will be used to measure sustainment of cognitive control of lexical processing, specifically measuring an individuals ability to continue to retrieve phonemic information after multiple trials, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to maintain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior sustainment of cognitive control of lexical processing. | During one day of cognitive assessment administration. |
| Lexical Processing Assessed by Letter Fluency, Fourth Interval | DKEFS Letter Fluency, fourth interval scores will be used to measure sustainment of cognitive control of lexical processing, specifically measuring an individuals ability to continue to retrieve phonemic information after multiple trials, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to maintain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior sustainment of cognitive control of lexical processing. | During one day of cognitive assessment administration. |
| BG001 | Post-gastric Bypass Participants Without a History of Hypoglycemia | Participants with a history of Roux-en-Y gastric bypass, but without a diagnosis of hypoglycemia, or symptoms of hypoglycemia, recruited by advertisement flyers at postoperative surgical clinics at local hospitals (such as Brigham and Women's and Beth Israel Deaconess Hospitals), research match, and from other hypoglycemia studies at Joslin. Cognitive Assessment (not diagnostic): Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed. ECG: ECG will take place during screening visit. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Northeastern United States | Number | participants |
|
| Current body mass index (kg/m^2) | Median | Standard Deviation | kg/m^2 |
|
| Body composition fat percentage (%) | Median | Standard Deviation | percent |
|
| Patient Health Questionnaire-2 (PHQ-2) score | Patient Health Questionnaire-2 (PHQ-2) scores were used to measure depressive symptoms. Scores for this assessment range from 0 to 6, with a higher score indicating greater severity of depressive symptoms. | Median | Standard Deviation | Scores on a scale (range 0 to 6) |
|
| Beck Depression Inventory score | Beck Depression Inventory scores were used to measure depressive symptoms. Scores for this assessment range from 0 to 63, with a higher score indicating greater severity of depressive symptoms. | Median | Standard Deviation | Scores on a scale (range is 0 to 63) |
|
| Alcohol Use Disorders Identification Test (AUDIT-C) score | Alcohol Use Disorders Identification Test (AUDIT-C) scores were used to measure alcohol use. Scores for this assessment range from 0 to 10, with a higher score indicating more alcohol use. | Median | Standard Deviation | Scores on a scale (range 0 to 10) |
|
| Alcohol use (drinks per week) | Median | Standard Deviation | number of alcoholic drinks per week |
|
| Number of participants with a smoking history | Count of Participants | Participants |
|
| Number of participants using recreational marijuana | Count of Participants | Participants |
|
| Years of education | Median | Standard Deviation | years |
|
| Duration of hypoglycemia (years) | Median | Standard Deviation | years |
|
| OG001 | Post-gastric Bypass Participants Without a History of Hypoglycemia | Participants with a history of Roux-en-Y gastric bypass, but without a diagnosis of hypoglycemia, or symptoms of hypoglycemia, recruited by advertisement flyers at postoperative surgical clinics at local hospitals (such as Brigham and Women's and Beth Israel Deaconess Hospitals), research match, and from other hypoglycemia studies at Joslin. Cognitive Assessment (not diagnostic): Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed. ECG: ECG will take place during screening visit. |
|
|
|
| Primary | Assessment of Delayed Verbal Memory | RAVLT 20 minute recall accuracy scores, was used to measure delayed memory and was compared between groups. Scores for this assessment range 0 to 15, with a higher score indicating less delays in memory. Wilcoxon rank-sum tests was used to examine differences between groups. | Posted | Median | Standard Deviation | RAVLT scores on a scale (range 0 to 15) | During the one day of cognitive assessment administration. |
|
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|
|
| Primary | Working Memory Assessed by the Letter Number Sequencing Scaled Score | Letter-Number Sequencing subtest from the Wechsler Memory Scale III scaled scores were used to measure working memory and were compared between groups. Wilcoxon rank-sum test was used to examine differences between groups. Scores for this assessment range 1 to 19, with a higher score indicating a superior working memory. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During the one day of cognitive assessment administration. |
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|
| Secondary | Assessment of Cognitive Flexibility Using Trails Scaled Score | Delis-Kaplan Executive Function System (DKEFS),Trail Making Task score was used to assess the cognitive flexibility component of executive function. Scores are derived from time to complete the task plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive flexibility. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During the one day of cognitive assessment administration. |
|
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|
|
| Secondary | Assessment of Cognitive Flexibility Using Color-word Inference Test | DKEFS Color-Word Interference Test (CWIT) Inhibition Switching scores was used to measure the cognitive flexibility component of executive function. The CWIT is scored by time to complete plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive flexibility. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During the one day of cognitive assessment administration. |
|
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|
|
| Secondary | Assessment of Inhibition Using Color-word Inference Test | DKEFS CWIT scores was used to measure the inhibition component of executive function. The CWIT is scored by time to complete plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior inhibition. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During the one day of cognitive assessment administration. |
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|
| Secondary | Verbal Ability Cognitive Control Assessed by Letter Fluency | DKEFS Letter Fluency Task will be used to assess the verbal functioning cognitive control ability component of executive function. Scores are derived from the number of unique, correct words. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior verbal functioning cognitive control ability. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During the one day of cognitive assessment administration. |
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|
| Secondary | Assessment of Psychomotor Speed | The grooved pegboard test is a manipulative dexterity task that assesses psychomotor speed, fine motor control, and rapid-visual motor coordination. Participants were asked to insert 25 grooved pegs into holes within the given time limit up to 300 seconds (the score upper limit is thus 300). Time taken to complete the test has been found to be inversely correlated with cognitive ability; therefore, a higher score represents an inferior score. Wilcoxon rank-sum test was used to examine differences between groups. | Posted | Median | Standard Deviation | Seconds | During the one day of cognitive assessment administration. |
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| Secondary | Verbal Ability Cognitive Control Assessed by Category Fluency | DKEFS Category Fluency scores were used to measure cognitive control of verbal ability, specifically measuring an individuals ability to access and retrieve semantic information (memory) as a component of executive function. Category fluency is scored by number of correct words plus errors in a 60 second trial in each of 3 categories. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During the one day of cognitive assessment administration. |
|
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| Secondary | Verbal Ability Cognitive Flexibility, Assessed by Category Switching Scaled Score | DKEFS Category Switching scores will be used to measure cognitive control of verbal ability, specifically measuring an individuals ability to access and retrieve semantic information (memory), switching back and forth between 2 different semantic categories, a component of executive function. Category switching is scored by number of correct words plus errors. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During the one day of cognitive assessment administration. |
|
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|
|
| Secondary | Verbal Ability Cognitive Control of Inhibition, Assessed by Category Switching Accuracy Scaled Score | DKEFS Category Switching Accuracy scores will be used to measure cognitive control of verbal ability, specifically measuring an individuals ability to inhibit incorrect or repetitive semantic information (memory), while switching back and forth between 2 different semantic categories, a component of executive function. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of verbal ability. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During the one day of cognitive assessment administration. |
|
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| Secondary | Lexical Processing Assessed by Letter Fluency, First Interval. | DKEFS Letter Fluency, first interval scores will be used to measure cognitive control of lexical processing, specifically measuring an individuals ability to retrieve phonemic information, a component of executive function. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. There are four intervals of this task the first assessing initiation of retrieval while the following trials measuring the ability to sustain retrieval. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of lexical processing. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During one day of cognitive assessement administration. |
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| Secondary | Lexical Processing as Assessed by Letter Fluency, Second Interval | DKEFS Letter Fluency, second interval scores will be used to measure cognitive control of lexical processing, specifically measuring an individuals ability to retrieve phonemic information, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to sustain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior cognitive control of lexical processing. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During one day of cognitive assessement administration. |
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| Secondary | Lexical Processing Assessed by Letter Fluency, Third Interval | DKEFS Letter Fluency, third interval scores will be used to measure sustainment of cognitive control of lexical processing, specifically measuring an individuals ability to continue to retrieve phonemic information after multiple trials, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to maintain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior sustainment of cognitive control of lexical processing. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During one day of cognitive assessment administration. |
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| Secondary | Lexical Processing Assessed by Letter Fluency, Fourth Interval | DKEFS Letter Fluency, fourth interval scores will be used to measure sustainment of cognitive control of lexical processing, specifically measuring an individuals ability to continue to retrieve phonemic information after multiple trials, a component of executive function. There are four intervals of this task the second through fourth trial assess ability to maintain retrieval. Participants are asked to name as many words a they are able starting with a specific letter, without repetition. Wilcoxon rank-sum test was used to examine differences between groups. Normative scores for this assessment range 1-19 (mean of 10, and standard deviation of 3), and a higher score indicates superior sustainment of cognitive control of lexical processing. | Posted | Median | Standard Deviation | Scores on a scale (range 1 to 19) | During one day of cognitive assessment administration. |
|
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Post-gastric Bypass Participants Without a History of Hypoglycemia | Participants with a history of Roux-en-Y gastric bypass, but without a diagnosis of hypoglycemia, or symptoms of hypoglycemia, recruited by advertisement flyers at postoperative surgical clinics at local hospitals (such as Brigham and Women's and Beth Israel Deaconess Hospitals), research match, and from other hypoglycemia studies at Joslin. Cognitive Assessment (not diagnostic): Cognitive testing will assess premorbid intelligence, working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed. ECG: ECG will take place during screening visit. | 0 | 7 | 0 | 7 | 0 | 7 |
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| D004568 | Electrodiagnosis |