Rosiglitazone and Insulin Resistance in Renally Impaired Patients

NCT00452166 | Terminated Phase 3 DMC

• 1 other identifier: p06-108a
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

30 non-diabetic, non-obese patients with stage 4 chronic kidney disease will be asked to participate in this metabolic study. The primary aim of this study is to determine the effect of rosiglitazone on insulin resistance in non-obese patients with non-diabetic stage 4 CKD. Secondary end points are the effects on inflammation (hsCRP), lipid profile, bone density and body composition.

Conditions

Chronic Kidney Disease; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Insulin sensitivity

  12 weeks

Secondary Outcomes (4)

• inflammation

  12 weeks

• lipid profile

  12 weeks

• bone density

  12 weeks

• body composition

  12 weeks

Interventions

rosiglitazone DRUG

Eligibility Criteria

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

You may qualify if:

• CKD stage 4
• BMI ≤ 30
• Fasting glucose \< 7 mmol/l

You may not qualify if:

• A diagnosis of diabetes mellitus for which the patient uses insulin
• Significant co-morbidities which, according to the treating nephrologists, makes it unlikely that the patient will be able to complete the foreseen study period
• Significant cardiovascular co-morbidities which are likely to interfere with the objectives of the study (morbid obesity, family history of dyslipidemia, etc.); at the discretion of the treating nephrologists or the principal investigator
• Allergy for PPAR's
• Cardiac disease with marked limitation of functional capacity (New York Heart Association III or IV clinical status)
• Use of immunosuppressant agents
• History of renal transplant
• Hepatic insufficiency (defined as transaminase concentrations above \> 2.5 times the upper limit of normal for the laboratories)
• A history of alcohol abuse or excessive alcohol use defined as more than 21 consumptions per week
• For female patients: pregnancy, the intention to become pregnant within the study period, or lactating patients

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

LUMC

Leiden, Netherlands

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Insulin Resistance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• andre gaasbeek, md

  LUMC leiden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: April 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 2, 2008

Record last verified: 2008-09

Locations

NL (1)