ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00737347
Recruitment Status : Completed
First Posted : August 19, 2008
Last Update Posted : August 19, 2008
Sponsor:
Collaborator:
Takeda
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Obesity Behavioral: Lifestyle modification Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
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
Study Start Date : September 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Responsible Party: Robert F. Kushner, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00737347     History of Changes
Other Study ID Numbers: 0309-015
First Posted: August 19, 2008    Key Record Dates
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