Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00304603|
Recruitment Status : Completed
First Posted : March 20, 2006
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment|
|Obesity Diabetes Mellitus Type 2||Other: No intervention|
|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|
|Actual Primary Completion Date :||April 2005|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|