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| Name | Class |
|---|---|
| Boston University | OTHER |
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The study team will investigate the racial differences in the metabolic and clinical responses to Medium chain triglycerides (MCT) between African American and Caucasian American subjects.
It is generally accepted that type 2 diabetes (T2D) arises from the progression of insulin resistance (IR), with hyperinsulinemia (HI) as a compensatory response. The possibility that HI can precede and contribute to insulin resistance (IR) and metabolic syndrome (MS) has been suggested but not tested in humans. While IR and HI are closely associated, demonstrating a primary role for HI in T2D is key to the development of new treatment strategies for this disease. One group in which HI could play a bigger role in T2D is African Americans (AA) who are known to be more hyperinsulinemic than Caucasian Americans (CA). Racial disparities in T2D treatment outcomes adversely affect AA. Our main hypothesis is that suppression of HI will contribute to the prevention and treatment of T2D, especially among AA. Our goal in this pilot study is to show that consumption of medium chain triglycerides (MCT) in the diet will decrease basal insulin secretion and HI, and will lead to improvement in the insulin sensitivity index (Si). 24 subjects (12 AA, 12 CA) will participate in a clinical trial in which they will receive MCT for 6 weeks. Insulin secretion dynamics and insulin sensitivity will be assessed by use of the frequently sampled intravenous glucose tolerance test (FSIVGTT) and Bergman's minimal model analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCT | Experimental | Medium chain triglyceride (MCT) oil ingested daily for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medium chain triglycerides (MCT) | Dietary Supplement | Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test | Baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 6 weeks in resting energy expenditure (kilocalories) | Baseline to 6 weeks | |
| Change from baseline to 6 weeks in body composition (% fat, muscle and bone) | Baseline to 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline M Apovian, MD | Boston Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Change baseline to 6 weeks in physical activity (minutes of moderate or vigorous activity performed) | Baseline to 6 weeks |
| Assessment of the following from Baseline to end of intervention: Adverse Events (AEs), Vital Signs, Anthropometrics | Baseline to 6 weeks |