A Clinical Trial to Prevent New Onset Diabetes After Transplantation
Status:
Completed
Trial end date:
2018-02-27
Target enrollment:
Participant gender:
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.