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NCT00737347 Clinical Trial

Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone

Obesity Clinical Trial

Official title:
Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00737347
Other study ID # 0309-015
Secondary ID
Status Completed
Phase Phase 3
First received August 15, 2008
Last updated August 18, 2008
Start date September 2003
Est. completion date April 2008

Study information
Verified date August 2008
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of the study is to investigate the effectiveness of three lifestyle treatment programs varying in level of intensiveness on prevention of pioglitazone-induced weight gain and to measure the composition of the change in body weight.

Description:

The three lifestyle interventions were usual care (1 visit), standard care (4 total visits) and intensive care (10 total visits)

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date April 2008
Est. primary completion date March 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 65 Years
Eligibility Inclusion Criteria:

- type 2 diabetes with BMI 27 or greater, glycated hemoglobin 7% or greater

Exclusion Criteria:

- insulin treated

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Lifestyle modification
lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling

Locations
Country Name City State
United States Northwestern Memorial Hospital Wellness Institute Chicago Illinois

Sponsors (2)
Lead Sponsor Collaborator
Northwestern University Takeda

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary change in body weight 24 weeks No
Secondary change in body composition 24 weeks Yes
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