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Completed

NCT Number: NCT00319189

Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

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.

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Key information

Conditions

Renal Transplant Recipients Posttransplant Diabetes Mellitus Posttransplant Impaired Glucose Tolerance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rikshospitalet, Section of Nephrology

Oslo, 0027, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nateglinide

Drug

Primary outcomes

  1. Glucose tolerance

  2. Insuline release

Secondary outcomes

  1. Glucose oxidation

  2. Postprandial hyperlipidemia

  3. Glomerular filtration rate

  4. HbA1C

  5. Fasting glucose

  6. Plasma nitric oxide

  7. Plasma endothelin-1

Sponsors and collaborators

Lead sponsor

University of Oslo School of Pharmacy

Other

Registry information

Official study title

Efficacy and Safety of Nateglinide Treatment in Renal Treatment Recipients With Post Transplant Diabetes Mellitus or Impaired Glucose Tolerance

Important dates

Study start
2002
Study completion
2003
First posted
Apr 27, 2006
Registry last updated
May 10, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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