NCT00319189

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
Last Updated

May 10, 2006

Status Verified

April 1, 2006

First QC Date

April 27, 2006

Last Update Submit

May 9, 2006

Conditions

Renal Transplant RecipientsPosttransplant Diabetes MellitusPosttransplant Impaired Glucose Tolerance

Keywords

NateglinideRenalKidneyTransplantationDiabetsGlucose

Outcome Measures

Primary Outcomes (2)

  • Glucose tolerance

  • Insuline release

Secondary Outcomes (7)

  • Glucose oxidation

  • Postprandial hyperlipidemia

  • Glomerular filtration rate

  • HbA1C

  • Fasting glucose

  • +2 more secondary outcomes

Interventions

NateglinideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet, Section of Nephrology

Oslo, 0027, Norway

Location

MeSH Terms

Interventions

Nateglinide

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Trond Jenssen, MD, PhD

    Rikshospitalet, Section of Nephrology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

November 1, 2002

Study Completion

November 1, 2003

Last Updated

May 10, 2006

Record last verified: 2006-04

Locations

NO(1)