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

Phase 3

Completed

• Conditions: Type 2 Diabetes; Obesity
• Interventions: Behavioral: Lifestyle modification

• Registration Number: NCT00737347
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2003-09
• Primary Completion: 2007-03
• Study Completion: 2008-04
• Status Verified: 2008-08
• Study First Submitted: 2008-08-15
• Study First Submitted QC: 2008-08-18
• Last Update Submitted: 2008-08-18
• Study First Posted: 2008-08-19
• Last Update Posted: 2008-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

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

Exclusion Criteria

• insulin treated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2.	Lifestyle modification	Standard care. Subjects had 4 sessions with registered dietitian
3	Lifestyle modification	Intensive care. subjects had 10 visits with registered dietitian

Primary Outcome Measures

Name	Time	Method
change in body weight	24 weeks

Secondary Outcome Measures

Name	Time	Method
change in body composition	24 weeks

Trial Locations

Locations (1)

Northwestern Memorial Hospital Wellness Institute; 🇺🇸 Chicago, Illinois, United States