Status:
COMPLETED
Obesity and Fatty Acid Flux Comparison Trials
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Eligibility:
All Genders
18-49 years
Brief Summary
This study will explore factors that affect obesity and obesity-related diseases in both Caucasians and African Americans. By looking at the rate at which the human body burns calories while at rest (...
Detailed Description
Thirty percent of Americans are obese. Women are more severely affected than men. African-Americans are more severely affected than Caucasians. To understand the metabolic consequences of obesity, it...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA - Population:
- A total of 134 subjects, age range 18 to 49 will be recruited.
- 64 African-Americans (32 men, 32 women)
- 56 Caucasians (35 men, 35 women)
- Within each racial group equal numbers of normal weight, overweight and obese subjects will be recruited.
- African-Americans: Individuals will be considered to be African-American if they self-identify as African-American and were born in the United States. Further they must describe both parents as being African-American and born in the United States.
- Age: We will recruit subjects between the ages of 18 and 49 years.
- Weight: Enrollees must weigh less than 136 kg (300 lbs) and have a BMI less than 36 kg/m(2).
- Screening Blood Work: To enroll subjects must have normal hemoglobin levels, electrolyte panel and normal kidney, thyroid and liver function tests.
- Hysterectomy: Women who have had hysterectomies may participate as long as they are less than or equal to 49 years of age and have normal gonadotropin levels.
- Weight and Exercise Regimens: Subjects must report that they have been weight stable for at least 3 months and will not initiate a rigorous exercise regimen during participation in the study.
- EXCLUSION CRITERIA:
- Age: As above, subjects less than 18 years or greater than 49 years will not be enrolled.
- Weight: Subjects greater than 136 kg (300 lbs) or BMI greater than 36 kg/m(2) will not be enrolled.
- Medications: Subjects taking medications that are known to affect the parameters under investigation will be excluded. Some examples of such medications are: oral contraceptives, depoprovera, antihyperglycemic medications, antihypertensives, hypolipidemics, steroids or antiobesity agents.
- Medical conditions, specifically: Diabetes, Hypertension and Hyperlipidemia.
- Breastfeeding: Women who are breastfeeding or have an infant less than four months of age will be excluded.
- Pregnancy: Pregnant women will be excluded from participating.
- Minority Status other than African-American: After the sample size necessary to achieve clinically relevant data is calculated, the plan is to seek permission from the IRB to expand this study by the enrollment of other minorities.
Exclusion
Key Trial Info
Start Date :
December 19 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00074945
Start Date
December 19 2003
End Date
February 28 2013
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892