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OpenTrials
Completed

NCT Number: NCT00737347

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

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.

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Key information

Conditions

Type 2 Diabetes Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northwestern Memorial Hospital Wellness Institute

Chicago, Illinois, 60611, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • insulin treated

Treatment and study plan

Lifestyle Modification

Behavioral

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

Other names: lifestyle behavioral counseling

Primary outcomes

  1. change in body weight

    Time frame: 24 weeks

Secondary outcomes

  1. change in body composition

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Takeda

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2008
First posted
Aug 19, 2008
Registry last updated
Aug 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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