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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014