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Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

Primary Purpose

Renal Transplant Recipients, Posttransplant Diabetes Mellitus, Posttransplant Impaired Glucose Tolerance

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Nateglinide
Sponsored by
University of Oslo School of Pharmacy
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Transplant Recipients focused on measuring Nateglinide, Renal, Kidney, Transplantation, Diabets, Glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rikshospitalet, Section of Nephrology

Outcomes

Primary Outcome Measures

Glucose tolerance
Insuline release

Secondary Outcome Measures

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

Full Information

First Posted
April 27, 2006
Last Updated
May 9, 2006
Sponsor
University of Oslo School of Pharmacy
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1. Study Identification

Unique Protocol Identification Number
NCT00319189
Brief Title
Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients
Official Title
Efficacy and Safety of Nateglinide Treatment in Renal Treatment Recipients With Post Transplant Diabetes Mellitus or Impaired Glucose Tolerance
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oslo School of Pharmacy

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Transplant Recipients, Posttransplant Diabetes Mellitus, Posttransplant Impaired Glucose Tolerance
Keywords
Nateglinide, Renal, Kidney, Transplantation, Diabets, Glucose

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nateglinide
Primary Outcome Measure Information:
Title
Glucose tolerance
Title
Insuline release
Secondary Outcome Measure Information:
Title
Glucose oxidation
Title
Postprandial hyperlipidemia
Title
Glomerular filtration rate
Title
HbA1C
Title
Fasting glucose
Title
Plasma nitric oxide
Title
Plasma endothelin-1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Trond Jenssen, MD, PhD
Organizational Affiliation
Rikshospitalet, Section of Nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rikshospitalet, Section of Nephrology
City
Oslo
ZIP/Postal Code
0027
Country
Norway

12. IPD Sharing Statement

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Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

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