An interventional study of Medium chain fatty acid (Octanoic and Decanoic acid) and Splenda (Placebo Control) in Diabetes Mellitus, Type 1, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2015-01-22.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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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This study's enrollment of 12 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Exclusion Criteria:
Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid)
Other: Splenda (Placebo Control)
Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.
Also known as: Medium Chain Triglycerides, Octanoic and Decanoic acid, Fractionated coconut oil
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.
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.
Time frame: 90 minutes
Delayed Verbal Memory
The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
Time frame: 90 minutes
Verbal Memory Recognition
The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
Time frame: 90 minutes
Digit Span Backward
The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
Time frame: 90 minutes
Letter/Number Sequencing
The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
Time frame: 90 minutes
Digit Symbol Coding
The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
Time frame: 90 minutes
Map Search (2min)
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Time frame: 90 minutes
Map Search (1min)
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Time frame: 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.
Time frame: 90 minutes
| Milestone | MCT Intervention First, Then Placebo | Placebo Intervention First, Then MCT Intervention |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
| Milestone | MCT Intervention First, Then Placebo | Placebo Intervention First, Then MCT Intervention |
|---|---|---|
| Started | 6 | 6 |
| Completed | 5 | 5 |
| Not completed | 1 | 1 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Milestone | MCT Intervention First, Then Placebo | Placebo Intervention First, Then MCT Intervention |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
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.
| units on a scale | Type 1 Diabetes With MCT Oil | Type 1 Diabetes Without MCT Oil |
|---|---|---|
| Euglycemia | 15.85 ± 0.66 | 17.36 ± 13.28 |
| Hypoglycemia | 14.97 ± 1.13 | 13.28 ± 1.04 |
The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
| units on a scale | Type 1 Diabetes With MCT Oil | Type 1 Diabetes Without MCT Oil |
|---|---|---|
| Euglycemia | 14.82 ± 1.25 | 15.33 ± 1.40 |
| Hypoglycemia | 14.80 ± 1.31 | 11.58 ± 0.71 |
The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
| units on a scale | Type 1 Diabetes With MCT Oil | Type 1 Diabetes Without MCT Oil |
|---|---|---|
| Euglycemia | 13.19 ± 0.53 | 14.27 ± 0.23 |
| Hypoglycemia | 13.29 ± 0.50 | 12.14 ± 0.19 |
The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
| units on a scale | Type 1 Diabetes With MCT Oil | Type 1 Diabetes Without MCT Oil |
|---|---|---|
| Euglycemia | 0.60 ± 0.05 | 0.64 ± 0.05 |
| Hypoglycemia | 0.58 ± 0.05 | 0.54 ± 0.05 |
The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
| units on a scale | Type 1 Diabetes With MCT Oil | Type 1 Diabetes Without MCT Oil |
|---|---|---|
| Euglycemia | 12.04 ± 0.81 | 11.07 ± 0.85 |
| Hypoglycemia | 10.97 ± 0.76 | 9.92 ± 0.71 |
The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
| units on a scale | Type 1 Diabetes With MCT Oil | Type 1 Diabetes Without MCT Oil |
|---|---|---|
| Euglycemia | 72.50 ± 5.27 | 74.04 ± 4.59 |
| Hypoglycemia | 74.99 ± 4.56 | 68.56 ± 3.54 |
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
| units on a scale | Type 1 Diabetes With MCT Oil | Type 1 Diabetes Without MCT Oil |
|---|---|---|
| Euglycemia | 73.30 ± 1.70 | 75.04 ± 1.92 |
| Hypoglycemia | 75.11 ± 1.51 | 74.67 ± 1.51 |
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
| units on a scale | Type 1 Diabetes With MCT Oil | Type 1 Diabetes Without MCT Oil |
|---|---|---|
| Euglycemia | 53.11 ± 4.16 | 50.35 ± 3.27 |
| Hypoglycemia | 48.42 ± 3.19 | 42.94 ± 2.31 |
This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.
| symbols/ 90 min | Type 1 Diabetes With MCT Oil | Type 1 Diabetes Without MCT Oil |
|---|---|---|
| Euglycemia | 2.86 ± 0.17 | 3.14 ± 0.26 |
| Hypoglycemia | 3.06 ± 0.20 | 3.46 ± 0.34 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MCT Intervention | — | 0/12 (0%) | 3/12 (25%) |
| Placebo Intervention | — | 0/12 (0%) | 0/12 (0%) |
| Event | MCT Intervention | Placebo Intervention |
|---|---|---|
| Gastrointestinal SymptomsGastrointestinal disorders | 3/12 | 0/12 |
The baseline number of subjects reflects the number of subjects with baseline data
| Age, Continuous(years) | Overall Number of Subjects |
|---|---|
| Mean | 34.8 ± 8.9 |
| Sex: Female, Male(Participants) | Overall Number of Subjects |
|---|---|
| Female | 6 |
| Male | 5 |
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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