A Clinical Trial to Prevent New Onset Diabetes After Transplantation (ITP-NODAT)

This study is currently recruiting participants.
Verified January 2014 by University of Michigan
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Fu L Luan, University of Michigan
ClinicalTrials.gov Identifier:
NCT01683331
First received: August 30, 2012
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Prevention of New Onset Diabetes Among Kidney Transplant Patients
Drug: Insulin treatment for hyperglycemia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Clinical Trial to Prevent New Onset Diabetes After Transplantation

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The incidence of NODAT 12 months after kidney transplantation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    NODAT will be defined according to American Diabetes Association definition:

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


Secondary Outcome Measures:
  • The incidence of NODAT 24 months after kidney transplantation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

    NODAT will be defined according to American Diabetes Association definition:

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


Other Outcome Measures:
  • Incidence of impaired fasting glycemia and impaired glucose tolerance 6, 12 and 24 months after transplantation. [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]

    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;



Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin treatment for hyperglycemia
Table 1. NPH Insulin Titration Regimen for Patients in Group A Pre-dinner Capillary blood glucose NPH dose initiation (IU/day) NPH dose adjustment(IU/day) > 240 mg/dl 14 Increase by 4 > 180 mg/dl 12 Increase by 4 > 140 mg/dl 10 Increase by 4 > 120 mg/dl 0 Increase by 2 100 to 119 mg/dl 0 Maintain the dose 80 - <100 mg/dl 0 Decrease by 4 60 - <80 mg/dl 0 Decrease by 8 < 60 mg/dl 0 Give ½ of previous dose
Drug: Insulin treatment for hyperglycemia
No Intervention: Standard of care
Patients assigned in this arm will receive standard of care following their kidney transplantation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients (> 18 years) with ESRD undergoing kidney transplantation;
  2. Standard triple immunosuppressive medications following kidney transplantation including tacrolimus, mycophenolate moftile and corticosteroids;
  3. Capable to understand the study protocol and to give informed consent;

Exclusion Criteria:

1. Type 1 and 2 DM either as co-morbidity or cause of ESRD;

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683331

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Diane M Cibrik, MD    734-763-9031    dcibrik@med.umich.edu   
Contact: Jennifer L Mawby, RN    734 936 4811    jlmawby@med.umich.edu   
Sub-Investigator: Diane M Cibrik, MD         
Principal Investigator: Akinlolu Ojo, MD         
Sub-Investigator: Fu L Luan, MD         
Sponsors and Collaborators
University of Michigan
Medical University of Vienna
Investigators
Principal Investigator: Akinlolu Ojo, MD University of Michigan
  More Information

No publications provided

Responsible Party: Fu L Luan, Clinical Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01683331     History of Changes
Other Study ID Numbers: 1R01DK092475-01
Study First Received: August 30, 2012
Last Updated: January 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Kidney transplant
New onset diabetes
Prevention
Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014