Evaluation of MCT in a Mixed Racial Population of Patients With Metabolic Syndrome: a Feasibility Study
Status: | Completed |
---|---|
Conditions: | Endocrine |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 6/28/2018 |
Start Date: | April 28, 2017 |
End Date: | June 20, 2018 |
Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients With Metabolic Syndrome: a Feasibility Study
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 with Metabolic Syndrome.
responses to Medium chain triglycerides (MCT) between African American and Caucasian American
subjects with Metabolic Syndrome.
Obese African Americans (AA) with metabolic syndrome (MS) are known to have more
hyperinsulinemia (HI) and insulin resistance (IR) than Caucasian Americans (CA). Racial
disparities in type 2 diabetes (T2D) outcomes adversely affect AA. Medium chain triglycerides
(MCT) are a safe and effective treatment for IR and MS but are not widely used. The
investigators' main aims are to determine the effects of MCT on insulin secretion and
clearance, insulin sensitivity, beta cell function, and the disposition index using the
frequently sampled intravenous glucose tolerance test (FSIVGTT) and Bergman's minimal model
analysis. The study team will investigate the racial differences in the metabolic and
clinical responses to MCT between AA and CA subjects with MS. The investigators aim to enroll
20 obese subjects (10 AA, 10 CA) with MS in an isocaloric study in which participants will
receive MCT supplementation daily for 6 weeks while maintaining stable weight. Insulin
secretion dynamics and insulin sensitivity will be assessed before and after the intervention
by FSIVGTT. The investigators hope to show that MCT can effectively reduce HI and IR in CA
and AA. These pilot data will provide the basis for a NIH grant submission to further
investigate the treatment of MS with MCT in a mixed racial population.
hyperinsulinemia (HI) and insulin resistance (IR) than Caucasian Americans (CA). Racial
disparities in type 2 diabetes (T2D) outcomes adversely affect AA. Medium chain triglycerides
(MCT) are a safe and effective treatment for IR and MS but are not widely used. The
investigators' main aims are to determine the effects of MCT on insulin secretion and
clearance, insulin sensitivity, beta cell function, and the disposition index using the
frequently sampled intravenous glucose tolerance test (FSIVGTT) and Bergman's minimal model
analysis. The study team will investigate the racial differences in the metabolic and
clinical responses to MCT between AA and CA subjects with MS. The investigators aim to enroll
20 obese subjects (10 AA, 10 CA) with MS in an isocaloric study in which participants will
receive MCT supplementation daily for 6 weeks while maintaining stable weight. Insulin
secretion dynamics and insulin sensitivity will be assessed before and after the intervention
by FSIVGTT. The investigators hope to show that MCT can effectively reduce HI and IR in CA
and AA. These pilot data will provide the basis for a NIH grant submission to further
investigate the treatment of MS with MCT in a mixed racial population.
Inclusion Criteria:
- English-speaking
- Males and female ambulatory subjects
- Self-identify as Caucasian/White or Black/African American
- Body Mass Index 27-45
- Diagnosis of metabolic syndrome by clinical criteria > at least 3 of the following:
- central adiposity
- triglycerides >=150 mg/dL or taking lipid-lowering agents
- HDL <=40 mg/dL in men and <=50 mg/dL in women or taking lipid-lowering agents
- blood pressure >=130/85 or drug treatment for hypertension
- fasting glucose >=100 or hemoglobin A1c >=5.7 and <=6.4
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
- 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 or lactating
- Any cognitive or other disorders that may interfere with participation
- 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
- Actively trying to become pregnant
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