Clinical trial NCT02783703: Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study
Official title: Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Hyperinsulinemia
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2016-05-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Males and female ambulatory subjects
* Self-identify as Caucasian/White or Black/African American
* Body Mass Index \<=45

Exclusion Criteria:

* Diagnosis of type 2 diabetes or hemoglobin A1c \>6.5
* Use of insulin, oral hypoglycemic, agents, or insulin-sensitizing agents
* Daily use of oral steroids
* Unstable weight within 3 months prior to baseline (e.g., weight gain or loss of \>3%)
* Use of any weight loss medications or sex hormone therapy
* Daily use of psychotropic medications (for schizophrenia, bipolar disorder, obsessive compulsive disorder, posttraumatic stress disorder, psychotic disorder, mania)
* Chronic kidney disease, on dialysis or history of renal transplant
* Poorly controlled cardiovascular disease or congestive heart failure
* Severe peripheral vascular disease or severe liver disease
* Cancer
* A condition requiring use of oxygen such as severe chronic obstructive pulmonary disease
* Women who are pregnant, lactating, or actively trying to become pregnant
* Any cognitive or other disorders that may interfere with participation or ability to follow restrictions
* Abnormal TSH levels (\<0.01 or \>1.5x the upper limit)
* Weight \>450 lb (205 kg) or height \> 6'6"
* Severe claustrophobia
* Has had or is preparing for bariatric surgery (pre- or post-bariatric)
* Medically required use of anticoagulant therapies
* Current use of MCT oil
* Anemia (hemoglobin and/or hematocrit outside sex-specific normal ranges)

Primary outcomes:
measure: Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Change from baseline to 6 weeks in resting energy expenditure (kilocalories)
timeFrame: Baseline to 6 weeks
measure: Change from baseline to 6 weeks in body composition (% fat, muscle and bone)
timeFrame: Baseline to 6 weeks
measure: Change baseline to 6 weeks in physical activity (minutes of moderate or vigorous activity performed)
timeFrame: Baseline to 6 weeks
measure: Assessment of the following from Baseline to end of intervention: Adverse Events (AEs), Vital Signs, Anthropometrics
timeFrame: Baseline to 6 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Caroline M Apovian, MD
role: PRINCIPAL_INVESTIGATOR
References: