Rosiglitazone-Induced Weight Gain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00225225
First received: September 21, 2005
Last updated: February 21, 2008
Last verified: February 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Rosiglitazone-Induced Weight Gain

Resource links provided by NLM:


Further study details as provided by Stanford University:

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

Secondary Outcome Measures:
  • develop specific dietary recommendations

Estimated Enrollment: 45
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00225225

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Marina Basina, MD    510-752-6332    marina.basina@kp.org   
Principal Investigator: Marina Basina         
Sponsors and Collaborators
Stanford University
GlaxoSmithKline
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00225225     History of Changes
Other Study ID Numbers: 96242, SPO# 34216
Study First Received: September 21, 2005
Last Updated: February 21, 2008
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014