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

August 30, 2012
January 10, 2014
August 2012
August 2017   (final data collection date for primary outcome measure)
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;
Same as current
Complete list of historical versions of study NCT01683331 on ClinicalTrials.gov Archive Site
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;
Same as current
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;

Same as current
 
A Clinical Trial to Prevent New Onset Diabetes After Transplantation
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prevention of New Onset Diabetes Among Kidney Transplant Patients
Drug: Insulin treatment for hyperglycemia
  • 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
    Intervention: Drug: Insulin treatment for hyperglycemia
  • No Intervention: Standard of care
    Patients assigned in this arm will receive standard of care following their kidney transplantation.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
August 2017
August 2017   (final data collection date for primary outcome measure)

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;

Both
18 Years and older
No
United States
 
NCT01683331
1R01DK092475-01
Yes
Fu L Luan, University of Michigan
University of Michigan
Medical University of Vienna
Principal Investigator: Akinlolu Ojo, MD University of Michigan
University of Michigan
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP