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

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ClinicalTrials.gov Identifier: NCT01683331
Recruitment Status : Completed
First Posted : September 11, 2012
Results First Posted : March 20, 2019
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
Medical University of Vienna
Information provided by (Responsible Party):
Akinlolu Ojo, University of Michigan

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Clinical Trial to Prevent New Onset Diabetes After Transplantation
Actual Study Start Date : August 2012
Actual Primary Completion Date : February 27, 2018
Actual Study Completion Date : February 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Insulin treatment for hyperglycemia
Neutral Protamine Hagedorn (NPH) Insulin Titration Regimen, based on pre-dinner capillary blood glucose measurements (CPG) expressed in mg/dl; All NPH initiation doses and dose adjustments are presented in IU/day For pts. with CPG > 240, NPH initiation: 14, dose increases by 4; For pts. with CPG > 180 mg/dl, NPH initiation: 12, dose increases by 4; For pts. with CPG > 140 mg/dl, NPH initiation: 10, dose increases by 4; For pts. with CPG > 120 mg/dl, NPH initiation: 0, dose increases by 2; For pts. with CPG 100-119 mg/dl, NPH initiation: 0, maintain dose; For pts. with CPG 80-<100 mg/dl, NPH initiation: 0, dose decrease by 4; For pts. with CPG 60-<80 mg/dl, NPH initiation: 0, decrease by 8; For pts. with CPG <60 mg/dl, NPH initiation: 0, 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.



Primary Outcome Measures :
  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:

    1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or
    2. 2 hours Oral Glucose Tolerance Test (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; Incidence is measured in terms of number of participants who meet any of these 4 criteria.


Secondary Outcome Measures :
  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:

    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:
  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;




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683331


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Medical University of Vienna
Investigators
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Principal Investigator: Akinlolu Ojo, MD University of Michigan
  Study Documents (Full-Text)

Documents provided by Akinlolu Ojo, University of Michigan:

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Responsible Party: Akinlolu Ojo, Emeritus Professor of Medicine, Active, University of Michigan
ClinicalTrials.gov Identifier: NCT01683331     History of Changes
Other Study ID Numbers: 1R01DK092475-01 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2012    Key Record Dates
Results First Posted: March 20, 2019
Last Update Posted: March 20, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: Yes

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

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