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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737347
First Posted: August 19, 2008
Last Update Posted: August 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Takeda
Information provided by:
Northwestern University
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Obesity Behavioral: Lifestyle modification Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Weight Gain in Adult Patients With Type 2 Diabetes Treated With Pioglitazone

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • change in body weight [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • change in body composition [ Time Frame: 24 weeks ]

Enrollment: 39
Study Start Date: September 2003
Study Completion Date: April 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
usual care. Subjects had one 90 minute visit with registered dietitian
Active Comparator: 2.
Standard care. Subjects had 4 sessions with registered dietitian
Behavioral: Lifestyle modification
lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling
Other Name: lifestyle behavioral counseling
Active Comparator: 3
Intensive care. subjects had 10 visits with registered dietitian
Behavioral: Lifestyle modification
lifestyle intervention includes meal planning, food preparation, food label reading, dining out, and physical activity counseling
Other Name: lifestyle behavioral counseling

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • insulin treated
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737347


Locations
United States, Illinois
Northwestern Memorial Hospital Wellness Institute
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Takeda
Investigators
Principal Investigator: Robert F Kushner, MD Northwestern University
  More Information

Responsible Party: Robert F. Kushner, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00737347     History of Changes
Other Study ID Numbers: 0309-015
First Submitted: August 15, 2008
First Posted: August 19, 2008
Last Update Posted: August 19, 2008
Last Verified: August 2008

Keywords provided by Northwestern University:
type 2 diabetes
obesity
weight gain
thiazolidinediones

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Weight Gain
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs