Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00433641
• Date of registration: 08/02/2007
• Primary sponsor: Mayo Clinic
• Public title: Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes
• Scientific title: Pharmacogenomics of Weight Loss With Sibutramine in Obese and Overweight Patients
• Date of first enrolment: July 2006
• Target sample size: 181
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00433641
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Michael L. Camilleri, M.D.
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

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).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Drug: sibutramine

Primary Outcome(s)

Association of weight loss with candidate genotypes [Time Frame: 2006-2007]

Secondary Outcome(s)

body composition (fat) [Time Frame: 2006-2007]

T1/2 gastric emptying of solids [Time Frame: 2006-2007]

Secondary ID(s)

06-003371

NIH DK67071

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institutes of Health (NIH)