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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00304603 |
Purpose
The purpose of this study is to explore the mode of action of topiramate in the treatment of obese and diabetic patients by testing association between genetic variations within candidate genes or chromosomes and the clinical outcomes.
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | A Study to Evaluate the Mode of Action of Topiramate in the Treatment of Obese Subjects With and Without Type 2 Diabetes Mellitus Using DNA Samples From Subjects Who Were Randomized Within Select Previous Topiramate Studies |
| Estimated Enrollment: | 1140 |
| Study Start Date: | April 2004 |
| Study Completion Date: | April 2005 |
Previous studies suggest that genetic factors may play a significant role in determining the amount of weight loss in response to pharmacological treatment. Topiramate is not approved for the treatment of obesity, but reported weight changes in response to treatment with topiramate may be linked to genetic factors. This pharmacogenomics (effect of genetic variation on drug response) study will analyze genetic variations in the DNA extracted from blood samples collected from subjects who were randomized in 1 of 3 previous topiramate studies on obesity and diabetes. The study consist of a screening telephone contact, a single visit to the study site for a blood sample collection (10ml of whole blood) for genetic analyses, and a 24-hour post-sample adverse event-reporting period. The goal of the study is to identify genes that impact percent change in weight and HbA1c from baseline at Week 24 (of the selected studies) and the occurrence of the most frequent central nervous system (CNS)-related adverse events in response to topiramate. The study hypothesis is that there are certain types of genes that are involved in the mode of action of topiramate.
No study drug was administered.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| ClinicalTrials.gov Identifier: | NCT00304603 History of Changes |
| Other Study ID Numbers: | CR003409 |
| Study First Received: | March 17, 2006 |
| Last Updated: | March 21, 2008 |
| Health Authority: | United States: Institutional Review Board |
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DNA Polymorphism Obesity Type 2 Diabetes Mellitus Pharmacogenomics Topiramate |
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Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overnutrition Nutrition Disorders Overweight Body Weight |
Signs and Symptoms Topiramate Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Anti-Obesity Agents |