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Rosiglitazone-Induced Weight Gain

This study has been terminated.
(due to published data on Rosiglitazone)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00225225
First Posted: September 23, 2005
Last Update Posted: October 20, 2016
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:
GlaxoSmithKline
Information provided by (Responsible Party):
Marina Basina, Stanford University
  Purpose

Given the high prevalence of type 2 diabetes and the 2- to 4-fold increased risk of fatal and non-fatal coronary heart disease events in these patients, long-term glycemic control is of great importance. TZDs improves glycemic control in patients with type 2 DM as well as enhances their insulin-mediated glucose disposal. However, the improvement of glycemic control seen with TZDs may be blunted in the long run by weight gain.

Previous data on weight gain during TZD therapy in patients with type 2 DM is very sparse. It is generally assumed that an increase in adipocyte differentiation is the cause of weight gain in association with TZD treatment which may limit their use. Increased body weight assumed to compromise the positive effects of treatment. There is also a theoretical concern that, with the development of new adipocytes, future weight loss may be difficult.

However, if weight gain is primarily due to failure to adjust caloric intake in proportion to the decrease in urinary glucose loss, it is totally preventable. It has been previously shown that improvement of glycemia favored weight gain by decreasing the energy loss in the urine as glucose. Severity of weight gain appears to be proportional to the level of glycemic control achieved.

The overall goal of the proposed research is to provide the experimental evidence for the later alternative by showing that the modest weight gain that takes place in association with effective rosiglitazone treatment of hyperglycemic patients with type 2 DM is primarily due to its therapeutic efficacy. More specifically, by decreasing the caloric intake in proportion to a decrease in urinary glucose loss associated with improved glycemic control, we will be able to prevent significant weight gain following Rosiglitazone treatment. In order to provide an optimal dietary modification that can be universally applied to TZD-treated patients in clinical practice, we will have a group with a fixed amount of caloric restriction per day. It will be the first randomized controlled trial of a potential strategy for prevention of weight gain associated with thiazolidinediones.


Condition Intervention
Diabetes Mellitus, Type 2 Drug: Rosiglitazone Behavioral: dietary recommendation for weight maintenance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rosiglitazone-Induced Weight Gain

Resource links provided by NLM:


Further study details as provided by Marina Basina, Stanford University:

Primary Outcome Measures:
  • modification of the diet prevents weight gain.

Secondary Outcome Measures:
  • develop specific dietary recommendations

Enrollment: 45
Study Start Date: October 2002
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fixed calorie (500 kcal) Reduction Drug: Rosiglitazone
Placebo Comparator: Control (no diet change) Drug: Rosiglitazone Behavioral: dietary recommendation for weight maintenance

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria:- 1) age between 30 and 70 years old, 2) normal chemical screening battery, 2) BMI less than 36 kg/M2, 3) non-controlled type 2 DM, defined by a fasting plasma glucose between 160 and 220 mg/dl, 4) individuals should be on a stable dose of sulfonylurea for at least one month prior to the enrollment. Exclusion Criteria:- 1) liver enzymes 2.5 times above normal values, 2) chronic inflammatory, neoplastic disease, 3) subjects with clinical evidence of congestive heart failure.
  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): NCT00225225


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
GlaxoSmithKline
  More Information

Publications:
Responsible Party: Marina Basina, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00225225     History of Changes
Other Study ID Numbers: 96242
SPO# 34216
First Submitted: September 21, 2005
First Posted: September 23, 2005
Last Update Posted: October 20, 2016
Last Verified: October 2016

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
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs