Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Leiden University Medical Center |
---|---|
Information provided by: | Leiden University Medical Center |
ClinicalTrials.gov Identifier: | NCT00452166 |
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.
Condition | Intervention | Phase |
---|---|---|
Chronic Kidney Disease Insulin Resistance |
Drug: rosiglitazone |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | Rosiglitazone and Insulin Resistance in Renally Impaired Patients |
Estimated Enrollment: | 30 |
Study Start Date: | April 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
This part of the study will be performed in 30 non-diabetic non-obese patients. In this study patients will receive single-dose oral placebo and rosiglitazone once daily to be taken in the morning. During the first 8 weeks the patients will be dosed with 4 mg rosiglitazone. Then the concentration of the serum transaminases will be checked and if these are within an acceptable range, the doses will be doubled for the remainder of the study. If the changes in serum transaminases are considered clinically significant the patient will be withdrawn from the study and if the transaminases have increased but not to clinically significant level then the treatment of patient may be continued on the 4 mg daily dose.
The insulin sensitivity will be measured by using a euglycaemic hyperinsulinaemic clamp technique, which is validated technique. Screening of eligible patients: fasting glucose ≤ 7,0 mmol/L and BMI ≤ 30.
Exclusion criteria are:
Insulin and glucose will be infused in the left arm. In healthy subjects, hepatic glucose production is completely suppressed when the serum insulin level is >60 mU/L. Here the expected insulin level in serum is 80 mU/L. Blood samples will be drawn at 5 min intervals for the determination of blood glucose, and at 10 min intervals during the period of 90 -120 min for the determination of serum insulin and free fatty acids. The insulin-sensitivity index (ISI) will be calculated by dividing the average glucose-infusion rate by the mean steady-state serum insulin levels during a period of 90 -120 min. In addition to glucose-infusion rate and insulin sensitivity index, the influence of the clamp on levels of FFA will also be assed.
At baseline and during the follow-up of the study inflammatory parameters (hsCRP) and lipids will be measured. At baseline and at the end a bone densitometry (DEXA) will be performed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Exclusion of patients will take place in case of:
Study ID Numbers: | p06-108a |
Study First Received: | March 26, 2007 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00452166 History of Changes |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Renal Insufficiency Metabolic Diseases Kidney Failure, Chronic Insulin Hyperinsulinism Hypoglycemic Agents Urologic Diseases |
Renal Insufficiency, Chronic Kidney Diseases Insulin Resistance Glucose Metabolism Disorders Metabolic Disorder Rosiglitazone Kidney Failure |
Renal Insufficiency Metabolic Diseases Physiological Effects of Drugs Kidney Failure, Chronic Pharmacologic Actions Hyperinsulinism Hypoglycemic Agents |
Urologic Diseases Renal Insufficiency, Chronic Insulin Resistance Kidney Diseases Glucose Metabolism Disorders Rosiglitazone Kidney Failure |