Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus
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
3 other identifiers
observational
1,145
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2004
Shorter than P25 for all trials
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
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 17, 2006
CompletedFirst Posted
Study publicly available on registry
March 20, 2006
CompletedNovember 28, 2012
November 1, 2012
1 year
March 17, 2006
November 27, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent change in weight
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.
Baseleine to Week 24
Secondary Outcomes (3)
Change in in glycosylated hemoglobin (HbA1c)
Baseline to Week 24
Number of patients with central nervous system (CNS) related adverse events
Baseline to Week 24
Number of patients with adverse events
Baseline to Week 24
Study Arms (1)
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.
Interventions
No treatment was given to the patients as this is an observational study.
Eligibility Criteria
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).
You may qualify if:
- Must have been randomized within the 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
- Must consent to participate and use data from previous clinical trials in connection with results from the genetic analyses
You may not qualify if:
- Patients who received a blood transfusion within 60 days before collecting DNA samples
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
Biospecimen
Whole blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2006
First Posted
March 20, 2006
Study Start
April 1, 2004
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
November 28, 2012
Record last verified: 2012-11