Clinical trial NCT00837655: Effect of Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure (CKD)
Official title: Study of the Effect of Treatment With Sevelamer on Glucose Tolerance and Insulin Sensitivity in Patients With Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Failure, Chronic
End-Stage Renal Disease
Insulin Resistance
Hyperphosphatemia
Keywords: Chronic kidney disease
End-stage renal disease
phosphate binder
insulin resistance
glucose intolerance
sevelamer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2009-02-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Change in insulin sensitivity and/or glucose tolerance from baseline to the end of the study, as obtained by ISIOGTT.
timeFrame: Week 12
Secondary outcomes:
measure: Change from baseline to the end of the trial in surrogate markers of phosphate balance (PTH, s-urea, s-creatinine, ionized Ca, phosphate).
timeFrame: Week 12
measure: Change from baseline to end of the study in markers of lipid homeostasis (total cholesterol, LDL, HDL, ApoA, ApoB, TG, free fatty acids)
timeFrame: Week 12
measure: Change from baseline to the end of the study in circulating inflammatory cytokines (hsCRP, TNF, fibrinogen, PAI, fetuin)
timeFrame: Week 12
measure: Number of adverse events directly attributable to sevelamer or calciumcarbonate treatments.
timeFrame: Weekly until end of study
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Anders Alvestrand, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Jonas Axelsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1210/jc.2002-021127.