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Completed

NCT Number: NCT01683331

A Clinical Trial to Prevent New Onset Diabetes After Transplantation

Specific Aim 1: To determine the clinical efficacy of early initiation of insulin therapy in decreasing the incidence of NODAT among de novo kidney transplant patients with manifested post-transplant hyperglycemia during the first week after transplantation.

Hypothesis 1: Early initiation of insulin therapy protects beta-cell from early stress related to the surgery and use of higher doses of immunosuppressive medications, and leads to lower incidence of NODAT at 1 and 2 years.

Specific Aim 2: To determine the improvement in overall glycemic control with the early initiation of insulin therapy.

Hypothesis 2: Early initiation of insulin therapy results in greater overall control of glycemia compared to standard care of dietary counseling, life-style modification, oral hypoglycemic agents and/or insulin as needed at 1 year.

Specific Aim 3: To determine the improvement in beta-cell function among patients assigned to the early initiation of insulin therapy at one year post-transplantation.

Hypothesis 3: Early initiation of insulin therapy protects beta-cell from glucotoxicity of post-transplant hyperglycemia and preserves better beta-cell function at 1 year.

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Key information

Conditions

Prevention of New Onset Diabetes Among Kidney Transplant Patients Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (> 18 years) with end stage renal disease (ESRD) undergoing kidney transplantation;
  • Standard triple immunosuppressive medications following kidney transplantation including tacrolimus, mycophenolate mofetil and corticosteroids;
  • Capable to understand the study protocol and to give informed consent;

Exclusion criteria

  • Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;

Treatment and study plan

Insulin treatment for hyperglycemia

Drug

Primary outcomes

  1. The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation

    Time frame: 12 months

    NODAT will be defined according to American Diabetes Association definition:

    • Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or
    • 2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or
    • Glycosylated hemoglobin A1c equal or greater than 6.5; and/or
    • On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria.

Secondary outcomes

  1. The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation

    Time frame: 24 months

    NODAT will be defined according to American Diabetes Association definition:

    • Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or
    • 2 hours OGTT values equal or greater than 200 mg/dl; and/or
    • Glycosylated hemoglobin A1c equal or greater than 6.5; and/or
    • On oral hypoglycemic agents and/or insulin therapy;

Other outcomes

  1. Incidence of Impaired Fasting Glycemia and Impaired Glucose Tolerance 6, 12 and 24 Months After Transplantation.

    Time frame: 6, 12 and 24 months

    Following American Diabetes Association's definition:

    Impaired fasting glycemia: fasting glucose levels between 100 and 125 mg/dl;

    Impaired glucose tolerance: 2 hours' OGTT values between 140 and 199 mg/dl;

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Medical University of Vienna

Registry information

Acronym: ITP-NODAT

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 11, 2012
Registry last updated
Mar 20, 2019

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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