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Trial record 1 of 1 for:    NCT04293367
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Fuel Utilization, Diet Composition, and Exercise in African American Women

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ClinicalTrials.gov Identifier: NCT04293367
Recruitment Status : Completed
First Posted : March 3, 2020
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Jeanine Albu, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Insulin Resistance Other: High Intensity Interval Training (HIIT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study team will conduct a randomized clinical trial in 48 healthy pre-menopausal sedentary overweight and obese African American women. The women will be randomized to two groups: a) half of the women in each diet group will be training (EX) and b) half of the women in each diet group will be sedentary (C). Each woman will participate over a 5 months period, through 4 menstrual cycles so that baseline and post-intervention measurements are done during the follicular phase of the menstrual cycle. The baseline and post-intervention measurements will be done after a 10-day period of controlled eucaloric High-Fat feeding. On Days 9-11 of the 10 -day period they will be in-patients in the CRR and they will all be sedentary. On Day 9 they will be admitted to the Metabolic Chamber and have 24-hour energy expenditure measurements as previously described which will be used for the diet on subsequent days in the CRR. On Day 10 they will be fed the same amount of calories they bu
Masking: Double (Participant, Investigator)
Masking Description: Potential subjects will be from an African American descent which will be defined as having all four grandparents reported as African Americans. The subjects will be healthy (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). Subjects will be excluded if there is any indication what so ever that they have any cardiac or pulmonary illnesses which may interfere with their capacity to exercise, if they are smokers, consume more than 2 oz. of ethanol/day, have had a weight change greater than + 2 kg in the past 3 months, are currently taking medications or have any physical conditions which may affect insulin action and/or lipid metabolism or have hyperlipidemia.
Primary Purpose: Treatment
Official Title: Fuel Utilization, Diet Composition, and Exercise in African American Women
Actual Study Start Date : June 1, 2009
Actual Primary Completion Date : April 16, 2013
Actual Study Completion Date : November 20, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
14 African American Women with obesity will be randomly assigned to the 14-week high intensity interval training program
Other: High Intensity Interval Training (HIIT)
HIIT involves exercising in blocks of time (typically 4-5 minutes) where a small percentage of the time (typically 1 minute) is spent above the anaerobic (lactate) threshold (the "work interval") followed by the remainder of the time at a sub-anaerobic threshold ("active recovery").

No Intervention: Control
14 African American Women with obesity will be randomly assigned to serve as a reference group, i.e. follow the same protocol as the experimental group, however, they will not undergo exercise training



Primary Outcome Measures :
  1. Change in Post-absorptive Lipid Oxidation [ Time Frame: Baseline and 14 weeks ]
    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.


Secondary Outcome Measures :
  1. Fitness (VO2peak) [ Time Frame: up to 14 weeks ]
    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.

  2. Glucose Disposal Rate (GDR) during the Hyperinsulinemic-Euglycemic Clamp [ Time Frame: up to 14 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04293367


Locations
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United States, New York
Mount Sinai St. Luke's Clinical Research Unit
New York, New York, United States, 10025
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Jeanine Albu Icahn School of Medicine at Mount Sinai
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeanine Albu, Professor of Medicine, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04293367    
Other Study ID Numbers: SLR 1-10-CT-01
#: 1-10-CT-01 ( Other Grant/Funding Number: American Diabetes Association )
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeanine Albu, Icahn School of Medicine at Mount Sinai:
Obesity
Prediabetes
metabolic flexibility
insulin sensitivity
high-intensity interval training
exercise tolerance
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases