Status:
COMPLETED
Gene Expression and Inflammation in Overweight Subjects
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity
Inflammation
Eligibility:
All Genders
25-45 years
Brief Summary
This study will look at gene expression (whether particular sets of genes are activated \["turned on"\] or deactivated \["turned off"\]) in overweight people as compared to non-overweight individuals....
Detailed Description
Obesity is a global public health problem of epidemic proportions. It is the source of considerable morbidity and early mortality in the U.S. and is associated with increased risk of diabetes, hyperte...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 25-45 years, male or female
- BMI 25.0-45.0 kg/m(2) for Overweight Subjects and 19.0-24.9 kg/m(2) for Non-Overweight Controls
- Healthy, as determined by medical history and laboratory tests
- Written informed consent
- EXCLUSION CRITERIA:
- BMI less than 19.0 or greater than 45.0 kg/m(2)
- History or symptoms compatible with cardiovascular disease, including arrhythmias and syncopal episodes, or use of prescription medications for heart conditions, strokes, or peripheral vascular disease
- Allergy to lidocaine
- Pregnancy or breastfeeding
- Menopause or peri-menopausal period (FSH greater than 15 mIU/ml)
- Use of hormonal contraceptives or estrogen replacement therapy
- Alcohol (more than 2 drinks per day or CAGE greater than 2 questions and/or current/regular use of drugs such as amphetamines, cocaine, heroin, or marijuana
- Current use of tobacco products (smoking or chewing)
- History of Diabetes Mellitus, either type 1 or 2, or Fasting Glucose greater than 126 mg/dl
- Use of cholesterol- or lipid-lowering drugs, or fasting serum lipids in range requiring medication per Adult Treatment Panel III recommendations of the National Cholesterol Education Program
- Liver disease or ALT serum level greater than two-fold above the laboratory reference standard
- Renal insufficiency or estimated creatinine clearance less than or equal to 50 ml/min
- Current use of medications, dietary supplements (including fish oils), or alternative therapies known to alter thyroid function with the exception of occasional use of NSAIDs (3 tablets/week maximum) and Benzodiazepines; use of NSAIDs in the 10 days preceding the hospital admissions
- Current history, symptoms, or behavior compatible with psychiatric disorders or therapy with psychotropic medications that would be incompatible with safe and successful participation in this study
- History of drug or alcohol abuse within the last 5 years; current use of drugs or alcohol
- Keloid formation (relative to subcutaneous adipose tissue biopsies)
- Hypo- or hyperthyroidism (TSH greater than or equal to 10; less than or equal to 0.1 mIU/L)
- Blood pressure greater than 160/95 mm Hg or use of prescription medications for treatment of hypertension
- Cushing Syndrome
Exclusion
Key Trial Info
Start Date :
June 19 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 26 2018
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00344266
Start Date
June 19 2006
End Date
June 26 2018
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892