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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00737347

Enrollment

Registered

2008-08-19

Start date

2003-09-30

Completion date

2008-04-30

Last updated

2008-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes

Keywords

type 2 diabetes, obesity, weight gain, thiazolidinediones

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)

Interventions

BEHAVIORALLifestyle modification

lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* insulin treated

Design outcomes

Primary

Measure	Time frame
change in body weight	24 weeks

Secondary

Measure	Time frame
change in body composition	24 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026