Weight Loss in Response to Sibutramine (MERIDIA) is Influenced by the Inherited Genes
Pharmacogenomics of Weight Loss With Sibutramine in Obese and Overweight Patients
2 other identifiers
interventional
181
1 country
1
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 intake. It is unclear whether the approved appetite reducing drug sibutramine changes the function of the stomach. Differences in the way individuals respond to treatment with the appetite suppressant sibutramine may also explain why some people lose weight while others do not. In a previous study of 48 overweight or obese participants, we preliminarily observed that variation in the gene for the promoter of the serotonin transporter protein was significantly associated with degree of weight loss. This new single center clinical study aims to evaluate the effects of the FDA-approved appetite suppressing medication, sibutramine (MERIDIA)on weight loss and stomach emptying in patients who are overweight or obese. The effect of individual differences in inherited genes that modify serrotonin and noradrenergic receptors on weight reduction with sibutramine will be tested.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 obesity
Started Jul 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 8, 2007
CompletedFirst Posted
Study publicly available on registry
February 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedMarch 14, 2011
March 1, 2011
1.3 years
February 8, 2007
March 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Association of weight loss with candidate genotypes
2006-2007
Secondary Outcomes (2)
T1/2 gastric emptying of solids
2006-2007
body composition (fat)
2006-2007
Study Arms (3)
1
PLACEBO COMPARATORplacebo tablet
2
EXPERIMENTALsibutramine
3
EXPERIMENTALsibutramine
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Grudell AB, Sweetser S, Camilleri M, Eckert DJ, Vazquez-Roque MI, Carlson PJ, Burton DD, Braddock AE, Clark MM, Graszer KM, Kalsy SA, Zinsmeister AR. A controlled pharmacogenetic trial of sibutramine on weight loss and body composition in obese or overweight adults. Gastroenterology. 2008 Oct;135(4):1142-54. doi: 10.1053/j.gastro.2008.07.009. Epub 2008 Jul 16.
PMID: 18725220DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael L. Camilleri, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 8, 2007
First Posted
February 12, 2007
Study Start
July 1, 2006
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
March 14, 2011
Record last verified: 2011-03