A Clinical Trial to Prevent New Onset Diabetes After Transplantation
Completed · Phase 4
Conditions studied: Prevention of New Onset Diabetes Among Kidney Transplant Patients
In brief
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.
Key facts
- Study ID
- NCT01683331
- Run by
- University of Michigan
- People needed
- 251
- Starts
- 2012-08-01
- Expected to finish
- 2018-02-27
- Last updated by the study team
- 2019-03-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;
Where it is running
- University of Michigan — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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