A Clinical Trial to Prevent New Onset Diabetes After Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/22/2019 |
| Start Date: | August 2012 |
| End Date: | February 27, 2018 |
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.
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.
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;
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