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Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00319189
Enrollment
15
Registered
2006-04-27
Start date
2002-11-30
Completion date
2003-11-30
Last updated
2006-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Nateglinide, Renal, Kidney, Transplantation, Diabets, Glucose

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.

Interventions

Sponsors

University of Oslo School of Pharmacy
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Glucose tolerance
Insuline release

Secondary

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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026