Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

Phase 4CompletedNCT00319189

University of Oslo School of Pharmacy15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Transplant Recipients Posttransplant Diabetes Mellitus Posttransplant Impaired Glucose Tolerance

Interventions

NateglinideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rikshospitalet, Section of Nephrology

Oslo, Norway

Outcomes

Primary Outcomes

Glucose tolerance

Insuline release

Secondary Outcomes

Glucose oxidation

Postprandial hyperlipidemia

Glomerular filtration rate

HbA1C

Fasting glucose

Plasma nitric oxide

Plasma endothelin-1

Data from ClinicalTrials.gov

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