Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT00304603|
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Obesity Diabetes Mellitus Type 2||Other: No intervention||Phase 3|
|Study Type :||Observational|
|Actual Enrollment :||1145 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||April 2004|
|Primary Completion Date :||April 2005|
|Study Completion Date :||April 2005|
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.
- Percent change in weight [ Time Frame: Baseleine to Week 24 ]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 ]
- Number of patients with central nervous system (CNS) related adverse events [ Time Frame: Baseline to Week 24 ]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 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304603
|Study Director:||Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|