Explore the NIHProtocol Details
Gene Expression and Release of Inflammatory Mediators in Overweight Subjects Before and After Weight Loss
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
06-DK-0183 |
Sponsoring Institute |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Obesity; |
Recruitment Keyword(s) |
Obesity; |
Condition(s) |
Overweight; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
Healthy individuals between 25 and 45 years of age may be eligible for this study. Overweight subjects must have a BMI of 25 to 40, and non-overweight control subjects a BMI of 19 to 24.9. Candidates are screened with a medical history, physical examination, blood tests and electrocardiogram (EKG). They are instructed to record their dietary intake for a 3-day period and to collect their urine for a 24-hour interval.
Participants have their food records reviewed a week after the screening visit. They are then scheduled for an overnight admission to the Clinical Center. Non-overweight subjects have one or two inpatient stays; overweight subjects have six inpatient stays plus frequent nutrition counseling sessions. During the 2-day hospital admissions, the following studies are performed:
-DEXA scan to determine the percentage of body fat tissue. The subject lies on a table for about 15 to 60 minutes while the body composition is measured with very low-dose x-rays.
-Single-slice CT scan to compare the amount of fat tissue under the skin with that in the abdomen. The subject lies on a table for about 5 to 10 minutes while the CT scanner measures body composition with very low-dose x-rays.
-Subcutaneous fat microdialysis to investigate how weight loss affects the activity of fat tissue. A small tube (catheter) is placed into the fat tissue under the skin of the abdomen after numbing the skin with a local anesthetic. Fluid samples are collected through the tube. The procedure lasts overnight. In five non-overweight controls, a small amount of a substance called leukotriene B4 is put into their fat tissue to help adjust the instruments used in the study.
-Air-displacement plethysmography to measure body composition. Subjects wear close-fitting clothing and enter a small capsule called a Bod-Pod. They breathe normally in the capsule while their body fat composition is studied.
-Blood tests. Blood samples are drawn to analyze thyroid hormones, lipids, glucose, electrolytes, clotting factors, kidney function, red cells and DNA.
-Euglycemic-hyperinsulinemic clamp to measure the effects of insulin in the body and to derive an index of insulin-sensitivity. Catheters are placed in a vein in an arm and in a vein in the hand on the other side of the body. Insulin and glucose are infused through the catheter in the arm, and blood samples are drawn from the catheter in the hand every 5 minutes to measure glucose levels. The test lasts about 2 hours.
-Subcutaneous fat biopsy to find out how weight loss affects fat tissue characteristics, gene regulation and the ability to store glucose. A small sample of fat tissue is obtained from the skin of the abdomen after numbing the area with an anesthetic.
-Nutrition counseling for overweight subjects. A nutritionist reviews the food record and designs a personalized diet for each participant.
-Weight loss intervention for overweight subjects. In addition to individual nutritional counseling, group sessions are provided every 2 weeks during the first 3 months of the study and then every month.
Eligibility
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
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information http://clinicalstudies.info.nih.gov. |
| Louis Simchowitz, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health Building 10 Room 9N311 10 Center Drive Bethesda, Maryland 20892 (301) 402-2373 jeffm@bdg10.niddk.nih.gov |
Joyce D. Linderman, R.N. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health Building 10 Room 9N311 10 Center Drive Bethesda, Maryland 20892 (301) 451-1048 rabela@niddk.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00344266
QUESTIONS?
Contact the Patient Recruitment and Public Liaison Office for:
- Details on how to participate in a study
- Details on how to refer a patient to a study
NIH Clinical Studies Information Request
Contact the Office of Communications for:
- General information about the NIH Clinical Center
Contact the Department Clinical Research Informatics, (DCRI) for:
- Technical questions about Adobe Acrobat and the PDF format
- Technical questions about this web server
