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| ID | Type | Description | Link |
|---|---|---|---|
| R37DK020495 | U.S. NIH Grant/Contract | View source | |
| DK20495 |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Juvenile Diabetes Research Foundation | OTHER |
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At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood sugar) and its effects on long-term brain function. The aim of this study is to determine whether the human brain is able to use medium chain fatty acids (MCFA) and/or their metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1 Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during episodes of hypoglycemia (low blood sugar.)
Twelve subjects between the ages of 18 years and 55 years who have had Type 1 Diabetes Mellitus for more than five years and have had tight control of their diabetes as determined by screening blood work will be invited to participate. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, cognitive testing will be performed during 90 minutes of normal blood glucose followed by 90 minutes of hypoglycemia. During the hypoglycemic period, either the MCFA or a placebo will be administered. Each subject will experience both conditions. The order in which the MCFA is given will be randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medium chain fatty acid (Octanoic and Decanoic acid) | Experimental |
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| Splenda (Placebo Control) | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medium chain fatty acid (Octanoic and Decanoic acid) | Dietary Supplement | Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations. |
| Measure | Description | Time Frame |
|---|---|---|
| Immediate Verbal Memory | Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement. | 90 minutes |
| Delayed Verbal Memory | The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement. | 90 minutes |
| Verbal Memory Recognition | The highest score is 15. The lowest score is 0. Higher scores indicate an improvement. | 90 minutes |
| Digit Span Backward | The highest score is 35. The lowest score is 0. The higher the score indicates an improvement. | 90 minutes |
| Letter/Number Sequencing | The highest score is 21. The lowest score is 0. Higher scores indicate an improvement. | 90 minutes |
| Digit Symbol Coding | The highest score is 133. The lowest score is 0. Higher scores indicate an improvement. | 90 minutes |
| Map Search (2min) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Sherwin, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MCT Intervention First, Then Placebo | A total of 40 grams of medium-chain triglycerides (derived from coconut oil containing 67% octanoate, 27% decanaote, and 6% other fatty acids) is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice |
| FG001 | Placebo Intervention First, Then MCT Intervention |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Sequence |
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| Splenda (Placebo Control) | Other | Placebo drink will consist of dietary sweetener Splenda mixed in water at a concentration of 1g/100mL. An unsweetened cherry flavor Koolaid mix will be added at a concentration of 0.3g/100mL of the Splenda drink to enhance flavor. |
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The highest score is 80. The lowest score is 0. Higher scores indicate an improvement. |
| 90 minutes |
| Map Search (1min) | The highest score is 80. The lowest score is 0. Higher scores indicate an improvement. | 90 minutes |
| Telephone Search | This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result. | 90 minutes |
A total of 40 grams of cherry-flavored water sweetened with sucralose is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice |
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| Wash Out Period |
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| Second Sequence |
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The baseline number of subjects reflects the number of subjects with baseline data
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Number of Subjects | 12 subjects started the study and 10 completed the study, however 11 subjects are reported in the baseline characteristics because one subjects withdrew before baseline data was collected. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||
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| Primary | Immediate Verbal Memory | Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement. | With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 minutes |
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| Primary | Delayed Verbal Memory | The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement. | With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 minutes |
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| Primary | Verbal Memory Recognition | The highest score is 15. The lowest score is 0. Higher scores indicate an improvement. | With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 minutes |
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| Primary | Digit Span Backward | The highest score is 35. The lowest score is 0. The higher the score indicates an improvement. | With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 minutes |
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| Primary | Letter/Number Sequencing | The highest score is 21. The lowest score is 0. Higher scores indicate an improvement. | With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 minutes |
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| Primary | Digit Symbol Coding | The highest score is 133. The lowest score is 0. Higher scores indicate an improvement. | With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 minutes |
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| Primary | Map Search (2min) | The highest score is 80. The lowest score is 0. Higher scores indicate an improvement. | With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 minutes |
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| Primary | Map Search (1min) | The highest score is 80. The lowest score is 0. Higher scores indicate an improvement. | With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 minutes |
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| Primary | Telephone Search | This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result. | With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance. | Posted | Least Squares Mean | Standard Error | symbols/ 90 min | 90 minutes |
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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) |
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| EG000 | MCT Intervention | 0 | 12 | 3 | 12 | |||
| EG001 | Placebo Intervention | 0 | 12 | 0 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Gastrointestinal Symptoms | Gastrointestinal disorders | Systematic Assessment |
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No technical limitations were seen.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Robert Sherwin | Yale School of Medicine | 203-785-6222 | robert.sherwin@yale.edu |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C031071 | decanoic acid |
| C026285 | trichlorosucrose |
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