Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus
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 (thread like structure found in cell which carries genes) and the clinical outcomes.
|Study Design:||Observational Model: Case Control
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|
- Percent change in weight [ Time Frame: Baseleine to Week 24 ] [ Designated as safety issue: No ]The candidate gene analyses and the genome (entire hereditary information of organism) screen for percent change in weight will be performed in 3 phases. 1) Find polymorphisms (existence of distinctly different types in group of 1 species) within candidate genes and chromosomal regions that impact response to topiramate. 2) Confirm Phase 1 findings. 3) Verify that polymorphisms and chromosomal regions that were associated with percent change in weight in 2 phases are associated with percent change in weight in response to topiramate rather than change in diet and exercise.
- Change in in glycosylated hemoglobin (HbA1c) [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
- Number of patients with central nervous system (CNS) related adverse events [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]Most frequent CNS-related adverse events (ie, paresthesia, depression, difficulty with concentration/attention, anorexia, difficulty with memory, fatigue, somnolence, insomnia, mood problems, and hypoesthesia) and adverse events related to venipuncture are monitored during the study.
- Number of patients with adverse events [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||April 2004|
|Study Completion Date:||April 2005|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
Patients from previous topiramate obesity and diabetes studies
The patients from previous topiramate obesity and diabetes studies (PRI/TOP-INT-31 or PRI/TOP-INT-33 or a subset of patients with diabetes mellitus who were randomized within the PRI/TOP-INT-34 study at sites that also participated in the PRI/TOP-INT-31 study.
Other: No intervention
No treatment was given to the patients as this is an observational study.
This pharmacogenomics (effect of genetic variation on drug response) study will analyze genetic variations in the DNA extracted from blood samples collected from patients who were randomized (assigned to treatments by chance) 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 (10 ml of whole blood) for genetic analyses, and a 24-hour post-sample adverse event reporting period. The total duration of the study is 24 hours from the time of the blood sample collection. Safety will be monitored up to 24 hours after blood sample collection. No study medication was administered.
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|