Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)
Information source: Karolinska Institutet
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Kidney Failure, Chronic; End-Stage Renal Disease; Insulin Resistance; Hyperphosphatemia
Intervention: Sevelamer (Drug); Calcium carbonate (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Karolinska Institutet Official(s) and/or principal investigator(s): Anders Alvestrand, MD PhD, Principal Investigator, Affiliation: Karolinska Institutet Jonas Axelsson, MD, PhD, Principal Investigator, Affiliation: Karolinska Institutet
Summary
The purpose of this study is to perform a randomized, controlled clinical trial to
investigate if the phosphate binder sevelamer can improve insulin resistance and glucose
handling in patients receiving maintenance hemodialysis.
Clinical Details
Official title: Study of the Effect of Treatment With Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.
Secondary outcome: Change from baseline to the end of the trial in surrogate markers of phosphate balance (PTH, s-urea, s-creatinine, ionized Ca, phosphate).Change from baseline to end of the study in markers of lipid homeostasis (total cholesterol, LDL, HDL, ApoA, ApoB, TG, free fatty acids) Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin) Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female patients 18-80 years of age with chronic renal failure treated with
maintenance HD for >3 months.
Exclusion Criteria:
- Diabetes mellitus
- Treatment with sevelamer within 3 months prior to enrollment
- Acute, clinically significant inflammation within 1 month prior to enrollment
- Pregnancy or breast-feeding
- Clinically significant obstipation or bowel obstruction
- Discontinuation of previous sevelamer treatment because of side effects
- Expected time in HD < 1 year
- Unwillingness to undergo the investigations and follow-up required in the the
protocol
- Patients who have received any investigational drug within 1 month prior to enrolment
- Participation in another study, which may interfere with the present study
Locations and Contacts
Sahlgrenska University Hospital, Gothenburg 413 45, Sweden
Karolinska University Hospital, Stockholm 14186, Sweden
Additional Information
Related publications: Soonthornpun S, Setasuban W, Thamprasit A, Chayanunnukul W, Rattarasarn C, Geater A. Novel insulin sensitivity index derived from oral glucose tolerance test. J Clin Endocrinol Metab. 2003 Mar;88(3):1019-23.
Starting date: January 2009
Last updated: September 25, 2012
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