Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

Phase 4

Completed

• Conditions: Renal Transplant Recipients; Posttransplant Diabetes Mellitus; Posttransplant Impaired Glucose Tolerance

• Registration Number: NCT00319189
• Lead Sponsor: University of Oslo School of Pharmacy

Brief Summary

The objective of the present study is to evaluate both the efficacy and safet of nateglinide in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose tolerance. Primarily will the change in glucose tolerance and acute insuline responce be addressed.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study Completion: 2003-11
• Status Verified: 2006-04
• Study First Submitted: 2006-04-27
• Study First Submitted QC: 2006-04-27
• Study First Posted: 2006-04-27
• Last Update Submitted: 2006-05-09
• Last Update Posted: 2006-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Reduced glucose tolerance (fasting glucose < 6.1 mmol/L AND 2 hour glucose between 6.7 and 9.9 mmol/L) or posttransplant diabetes mellitus (fasting glucose > 6.1 mmol/L OR 2 hour glucose between >= 10.0 mmol/L)
• Stable patients fgollowing renal transplantation, less than 25% variation in serum creatinine last week and serum creatinine < 200 micromol/L

Exclusion Criteria

• Patients with indulin dependent diabetes mellitus before or after transplantation
• Planned change in daily prednisolone dose during the study period
• Haemoglobin < 8g/dL

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Glucose tolerance
Insuline release

Secondary Outcome Measures

Name	Time	Method
Glucose oxidation
Postprandial hyperlipidemia
Glomerular filtration rate
HbA1C
Fasting glucose
Plasma nitric oxide
Plasma endothelin-1

Trial Locations

Locations (1)

Rikshospitalet, Section of Nephrology; 🇳🇴 Oslo, Norway