Status:
COMPLETED
Pharmacodynamic Effects of Sibutramine on Gastric Function in Obesity
Lead Sponsor:
Mayo Clinic
Conditions:
Obesity
Overweight
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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: Control of food intake, size and frequency of meals are critical to the development of obesity. The stomach signals satiation in response to calories and volume ingested, playing a role in...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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 Criteria
- 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).
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00330525
Start Date
January 1 2005
End Date
March 1 2006
Last Update
January 20 2010
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905