A Clinical Trial to Prevent New Onset Diabetes After Transplantation

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

251 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2018-02-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Prevention of New Onset Diabetes Among Kidney Transplant Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Insulin treatment for hyperglycemia

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.

Group Type ACTIVE_COMPARATOR

Insulin treatment for hyperglycemia

Intervention Type DRUG

Standard of care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Insulin treatment for hyperglycemia

Intervention Type DRUG

Eligibility Criteria

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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;