Phase 4
N=36
A Clinical Trial to Prevent New Onset Diabetes After Transplantation
Prevention of New Onset Diabetes Among Kidney Transplant Patients
Bottom Line
View on ClinicalTrials.gov: NCT01683331 ↗Enrolled (actual)
36
Serious AEs
69.4%
Results posted
Mar 2019
Primary outcome: Primary: The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation — 3; 1 Participants — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Insulin treatment for hyperglycemia (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation |
3; 1 | 0.87 |
| SECONDARY The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation |
1; 0 | 0.92 |
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.
Eligibility Criteria
Inclusion Criteria
- 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;
Exclusion Criteria
- Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;
Data sourced from ClinicalTrials.gov (NCT01683331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.