Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452166
Status:
TERMINATED
Last Update Posted:
2008-10-02
First Post:
2007-03-26
Brief Title:
Rosiglitazone and Insulin Resistance in Renally Impaired Patients
Sponsor:
Leiden University Medical Center
Organization:
Leiden University Medical Center
Study Overview
Official Title:
Rosiglitazone and Insulin Resistance in Renally Impaired Patients
Status:
TERMINATED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
it was not possible to recruit new patients anymore
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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remainder of the study If the changes in serum transaminases are considered clinically significant the patient will be withdrawn from the study and if the transaminases have increased but not to clinically significant level then the treatment of patient may be continued on the 4 mg daily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 70 mmolL and BMI 30
Exclusion criteria are
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 PPARs
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 25 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 Eligible patients will receive insulin Actrapid Novo Nordisk AS Copenhagen Denmark at an infusion rate of 40 mU 288 pmolkgm2 body surface area per minute Euglycemia target blood concentration of 5 mM will be maintained by adjusting the rate of 20 glucose infusion according to whole blood glucose concentration measured from arterialized venous blood the patient keeps his or her right arm in a box containing heated air 60C 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 mUL Here the expected insulin level in serum is 80 mUL 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
The insulin sensitivity will be measured by using a euglycaemic hyperinsulinaemic clamp technique which is validated technique
Screening of eligible patients fasting glucose 70 mmolL and BMI 30
Exclusion criteria are
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 PPARs
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 25 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 Eligible patients will receive insulin Actrapid Novo Nordisk AS Copenhagen Denmark at an infusion rate of 40 mU 288 pmolkgm2 body surface area per minute Euglycemia target blood concentration of 5 mM will be maintained by adjusting the rate of 20 glucose infusion according to whole blood glucose concentration measured from arterialized venous blood the patient keeps his or her right arm in a box containing heated air 60C 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 mUL Here the expected insulin level in serum is 80 mUL 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None