An interventional study of Medium chain triglycerides (MCT) in Insulin Resistance, sponsored by Boston Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by Boston Medical Center · Not applicable, Interventional, and Other
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.
1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.
Browse Insulin Resistance studies →Boston Medical Center is the lead sponsor of 314 studies on the registry; 34 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Medium chain triglyceride (MCT) oil ingested daily for 6 weeks
Dietary Supplement: Medium chain triglycerides (MCT)
Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth
Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test
Time frame: Baseline to 6 weeks
Change from baseline to 6 weeks in resting energy expenditure (kilocalories)
Time frame: Baseline to 6 weeks
Change from baseline to 6 weeks in body composition (% fat, muscle and bone)
Time frame: Baseline to 6 weeks
Change baseline to 6 weeks in physical activity (minutes of moderate or vigorous activity performed)
Time frame: Baseline to 6 weeks
Assessment of the following from Baseline to end of intervention: Adverse Events (AEs), Vital Signs, Anthropometrics
Time frame: Baseline to 6 weeks
Plan to share: No — Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.
No publications or documents are linked to this record.
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boston Medical Center