Status:
COMPLETED
Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Control of food intake, size and frequency of meals are critical to the development of obesity. The stomach signals feelings of fullness after a meal and therefore plays a role in control of calorie i...
Detailed Description
Background:. Genetic variations are potentially key to inter-individual differences in responses to treatment with the appetite suppressant sibutramine. Overall Aims: To evaluate influence of genetic...
Eligibility Criteria
Inclusion
- Normal weight, overweight and obese subjects with BMI\> 18 Kg/m2 residing in Olmsted County, MN: Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease.
- Age: 18-65 years
- Gender: Men or women. Women of childbearing potential will have negative pregnancy test within 48 h of enrollment and before each radiation exposure.
Exclusion
- Weight exceeding 300 pounds or 137 kilograms (due to limitations regarding SPECT imaging studies).
- Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.
- Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility or use of medications that may alter gastrointestinal motility, appetite or absorption e.g., orlistat (Xenical\).
- Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale \[HADS\] self-administered alcoholism screening test (substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HADS score \>8 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
- Intake of medication, whether prescribed or OTC medication (except multivitamins) within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, and thyroxine replacement.
- Concomitant use of MAOI inhibitors and other centrally acting appetite suppressants (since this would make them ineligible for sibutramine treatment).
- Hypersensitivity to sibutramine (since this would make them ineligible for sibutramine treatment).
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00433641
Start Date
July 1 2006
End Date
November 1 2007
Last Update
March 14 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905