Rosiglitazone-Induced Weight Gain

NCT00225225 | Terminated

• 2 other identifiers: 96242SPO# 34216
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• modification of the diet prevents weight gain.

Secondary Outcomes (1)

• develop specific dietary recommendations

Study Arms (2)

fixed calorie (500 kcal) Reduction

ACTIVE COMPARATOR

Drug: Rosiglitazone

Control (no diet change)

PLACEBO COMPARATOR

Drug: Rosiglitazone; Behavioral: dietary recommendation for weight maintenance

Interventions

Rosiglitazone DRUG

Control (no diet change); fixed calorie (500 kcal) Reduction

dietary recommendation for weight maintenance BEHAVIORAL

Control (no diet change)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Stanford University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (4)

• Vasudevan AR, Balasubramanyam A. Thiazolidinediones: a review of their mechanisms of insulin sensitization, therapeutic potential, clinical efficacy, and tolerability. Diabetes Technol Ther. 2004 Dec;6(6):850-63. doi: 10.1089/dia.2004.6.850.

  PMID: 15684639 BACKGROUND

• Asnani S, Richard BC, Desouza C, Fonseca V. Is weight loss possible in patients treated with thiazolidinediones? Experience with a low-calorie diet. Curr Med Res Opin. 2003;19(7):609-13. doi: 10.1185/030079903125002306.

  PMID: 14606983 BACKGROUND

• Camp HS. Thiazolidinediones in diabetes: current status and future outlook. Curr Opin Investig Drugs. 2003 Apr;4(4):406-11.

  PMID: 12808879 BACKGROUND

• Viberti GC. Rosiglitazone: potential beneficial impact on cardiovascular disease. Int J Clin Pract. 2003 Mar;57(2):128-34.

  PMID: 12661797 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: October 1, 2002
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: October 20, 2016

Record last verified: 2016-10

Locations

US (1)