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

University of Michigan

Status and phase: Completed; Phase 4

Conditions: Prevention of New Onset Diabetes Among Kidney Transplant Patients

Treatments: Drug: Insulin treatment for hyperglycemia

Study type: Interventional

Funder types: Other

Identifiers

NCT01683331

1R01DK092475-01

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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251 participants in 2 patient groups

Insulin treatment for hyperglycemia

Active Comparator group

Description:

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.

Treatment:

Drug: Insulin treatment for hyperglycemia

Standard of care

No Intervention group

Description:

Patients assigned in this arm will receive standard of care following their kidney transplantation.