Obesity Clinical Trial
Official title:
Fuel Utilization, Diet Composition, and Exercise in African American Women
Verified date | February 2020 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
African American women have a high prevalence of obesity and type 2 diabetes and do not optimally burn fat and carbohydrates in response to changes in these nutrients in their diets. This research project seek to determine if high intensity interval training (HIIT) exercise training can help healthy, but inactive, premenopausal, non-diabetic women increase their bodies' use of fat and carbohydrates when provided with a high fat or low fat diets. In this study, investigators will measure the rate at which fat is burned in response to weight maintaining low-fat and high-fat diets and how exercise may affect these responses.
Status | Completed |
Enrollment | 28 |
Est. completion date | November 20, 2013 |
Est. primary completion date | April 16, 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - African American descent and all four grandparents reported as African Americans - DNA will also be collected so admixture could be measured post study - Reported good health (blood work, Hx and PE) - Non-diabetic (OGTT) - Pre-menopausal, Age range 20-40 years BMI range of 25-40, with regular menstrual periods - Sedentary (exercise no more than 2 times/week, for one hour or spend no more than 1000 - 1500 Kcal/wk in physical activity as determined by a Paffenbarger questionnaire). Exclusion Criteria: - Any cardiac or pulmonary illnesses which may interfere with their capacity to exercise - Active smoker - Consume more than 2 oz. of ethanol/day - Weight change greater than + 2 kg in the past 3 months - Currently taking medications or have any physical conditions which may affect insulin action and/or lipid metabolism or have hyperlipidemia (plasma triglyceride greater than or equal to 350 mg/dl or total cholesterol levels greater than or equal to 300 mg/dl). - Metal implants (ex: pacemaker, implanted jewelry, etc) - 1st degree family history of type diabetes 2 diabetes (Will be noted but will not constitute an exclusionary criteria). The subjects' usual diets will be evaluated by the Block 98.2 Food Frequency Questionnaire (BDDS, Berkeley, CA). |
Country | Name | City | State |
---|---|---|---|
United States | Mount Sinai St. Luke's Clinical Research Unit | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Post-absorptive Lipid Oxidation | Resting ventilatory and gas exchange measurements will be done using indirect calorimetry using open circuit gas analysis at baseline and post intervention. Measurements and calculations for substrate utilization will be done as described and published using before and will be expressed as µmoles/KgFFM/min. | Baseline and 14 weeks | |
Secondary | Fitness (VO2peak) | All subjects will perform an incremental cycle ergometry test, at baseline and post intervention. The tests will be done before the 10-day eucaloric dietary challenges periods and data will be also used to determine the dietary prescription. | up to 14 weeks | |
Secondary | Glucose Disposal Rate (GDR) during the Hyperinsulinemic-Euglycemic Clamp | The subjects will be admitted at the CRR's inpatient physiology room to perform a Hyperinsulinemic-Euglycemic Clamp . The protocol used will be specific for measurements of insulin- mediated glucose disposal of the muscle. For 3 hours, plasma insulin concentration will be raised to around 200µU/ml using an insulin infusion of 80mU/m2 and the investigators will maintain euglycemia at around 100 mg/dl plasma glucose using a variable infusion of exogenous glucose of known concentration (20% glucose). Hepatic glucose production is expected to be completely suppressed at this level of insulin for these obese, but otherwise generally healthy women. | up to 14 weeks |
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