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Mode of Action of Topiramate in the Treatment of Obese Patients With and Without Type 2 Diabetes Mellitus

NCT ID: NCT00304603

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Obesity Diabetes Mellitus Type 2

Keywords

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Obesity Type 2 Diabetes Mellitus Topiramate Pharmacogenomics DNA Polymorphism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No intervention

Intervention Type OTHER

No treatment was given to the patients as this is an observational study.

Interventions

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No intervention

No treatment was given to the patients as this is an observational study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients who received a blood transfusion within 60 days before collecting DNA samples
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=527&filename=CR003409_CSR.pdf

A Study to Explore 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 Obesity and Diabetes Studies

Other Identifiers

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TOPMAT-OBE-3001

Identifier Type: OTHER

Identifier Source: secondary_id

RWJ-17021-000

Identifier Type: OTHER

Identifier Source: secondary_id

CR003409

Identifier Type: -

Identifier Source: org_study_id