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

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00737347
First received: August 15, 2008
Last updated: August 18, 2008
Last verified: August 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in body composition [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Robert F. Kushner, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00737347     History of Changes
Other Study ID Numbers: 0309-015
Study First Received: August 15, 2008
Last Updated: August 18, 2008
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 27, 2014