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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23DK098286-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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To investigate whether the daily glucose profiles as assessed by continuous glucose monitoring for 1 week of normal weight and obese individuals relate to hunger levels and food intake.
To evaluate the effect of blood glucose levels on eating behavior in a population of patients with diabetes in a free-living environment; the investigators plan to study lean healthy control subjects (BMI <25 kg/m2) and obese non-diabetic subjects (BMI > 30 kg/m2).
The participants who qualify will be invited to use the CGMS (DEXCOM G4 Platinum) for up to 7 days. On the visit for placement of the CGMS: 1) the participants will be explained by one of the study physicians how to use a glucometer (FreeStyle or Accu-Check), 2) they will have the CGMS inserted under the skin, and 3) they will be instructed how to fill up the food log (informational brochures are available at the end of the protocol. On the second visit (up to 7 days after the initial visit) the CGMS will be removed from the skin and the glucose meter and food log will be returned to the investigators.
When this study was initially designed, it incorporated 2 additional arms in the study: T1DM and obese T2DM patients. These patients were never recruited for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lean Healthy Control | Active Comparator | (BMI <25 kg/m2) |
|
| Obese non-diabetic subject | Active Comparator | BMI > 30 kg/m2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring System (CGMS) | Device | The CGMS consists of 3 parts: sensor, transmitter and monitor. The small sensor measures the glucose levels from the interstitial tissue. The transmitter is attached on top of the sensor and connects wirelessly to the monitor. The sensor is sterile and comes in an unopened package. It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels. One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit. The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch. The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Changing Glucose Level | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min). | 3-5 days |
| Glucose Peak | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl). | 3-5 days |
| Glucose Nadir | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl). | 3-5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Glucose Peak and Nadir | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the difference in glucose peak and nadir (mg/dl). | 3-5 days |
| Average Daily Hunger Rating |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renata Belfort De Aguiar, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital | New Haven | Connecticut | 06519-1362 | United States | ||
| Yale University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | Typical Weight Participants | Participants with a BMI <25 kg/m2. |
| FG001 | Obese Non-diabetic Pariticpants | Non-diabetic participants with a BMI > 30 kg/m2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Typical Weight Participants | Participants with a BMI <25 kg/m2. |
| BG001 | Obese Non-diabetic Pariticpants | Non-diabetic participants with a BMI > 30 kg/m2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Changing Glucose Level | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the rate of changing glucose level (mg/dl/min). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dl/min | 3-5 days |
|
|
Adverse events were monitored for up to 7 days of wearing the CGM.
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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 | Typical Weight Participants | Participants with a BMI <25 kg/m2. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Renata Belfort De Aguiar, MD, PhD; Assistant Professor of Medicine (Endocrinology) | Yale University School of Medicine | (877) 925-3637 | renata.aguiar@yale.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 | Oct 24, 2018 | Jan 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
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| Food log | Behavioral | The Food Record will ask about amount and type of food consumed throughout the day. The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity |
|
Average daily hunger was measured using a self-report scale. Hunger is measured on a scale from 1-10. 10 is the most hungry, 1 is the least hungry.
| 3-5 days |
| Nutirion Intake: Energy | Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily energy intake (kcal/day). | 3-5 days |
| Nutirion Intake: Carbohydrate | Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily carbohydrate intake (g/day). | 3-5 days |
| Nutirion Intake: Fat | Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily fat intake (g/day). | 3-5 days |
| Nutirion Intake: Protein | Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily protein intake (g/day). | 3-5 days |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| A1c (%) | Mean | Standard Deviation | % |
|
| BMI (kg/m2) | Mean | Standard Deviation | kg/m2 |
|
| Participants |
|
|
| Primary | Glucose Peak | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose peak (mg/dl). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dl | 3-5 days |
|
|
|
| Primary | Glucose Nadir | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the glucose nadir (mg/dl). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dl | 3-5 days |
|
|
|
| Secondary | Difference in Glucose Peak and Nadir | The CGM sensor measures the glucose levels from the interstitial tissue. Presented is the difference in glucose peak and nadir (mg/dl). | Posted | Least Squares Mean | 95% Confidence Interval | mg/dl | 3-5 days |
|
|
|
| Secondary | Average Daily Hunger Rating | Average daily hunger was measured using a self-report scale. Hunger is measured on a scale from 1-10. 10 is the most hungry, 1 is the least hungry. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 3-5 days |
|
|
|
| Secondary | Nutirion Intake: Energy | Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily energy intake (kcal/day). | Posted | Least Squares Mean | 95% Confidence Interval | kcal/day | 3-5 days |
|
|
|
| Secondary | Nutirion Intake: Carbohydrate | Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily carbohydrate intake (g/day). | Posted | Least Squares Mean | 95% Confidence Interval | g/day | 3-5 days |
|
|
|
| Secondary | Nutirion Intake: Fat | Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily fat intake (g/day). | Posted | Least Squares Mean | 95% Confidence Interval | g/day | 3-5 days |
|
|
|
| Secondary | Nutirion Intake: Protein | Data were collected through food journals. Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R). Presented is the average daily protein intake (g/day). | Posted | Least Squares Mean | 95% Confidence Interval | g/day | 3-5 days |
|
|
|
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Obese Non-diabetic Pariticpants | Non-diabetic participants with a BMI > 30 kg/m2. | 0 | 15 | 0 | 15 | 0 | 15 |
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| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |