A Clinical Trial to Prevent New Onset Diabetes After Transplantation (ITP-NODAT)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prevention of New Onset Diabetes Among Kidney Transplant Patients |
Drug: Insulin treatment for hyperglycemia |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Clinical Trial to Prevent New Onset Diabetes After Transplantation |
- The incidence of NODAT 12 months after kidney transplantation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
NODAT will be defined according to American Diabetes Association definition:
- Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or
- 2 hours OGTT values equal or greater than 200 mg/dl; and/or
- Glycosylated hemoglobin A1c equal or greater than 6.5; and/or
- On oral hypoglycemic agents and/or insulin therapy;
- The incidence of NODAT 24 months after kidney transplantation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
NODAT will be defined according to American Diabetes Association definition:
- Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or
- 2 hours OGTT values equal or greater than 200 mg/dl; and/or
- Glycosylated hemoglobin A1c equal or greater than 6.5; and/or
- On oral hypoglycemic agents and/or insulin therapy;
- Incidence of impaired fasting glycemia and impaired glucose tolerance 6, 12 and 24 months after transplantation. [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
Following American Diabetes Association's definition:
Impaired fasting glycemia: fasting glucose levels between 100 and 125 mg/dl;
Impaired glucose tolerance: 2 hours' OGTT values between 140 and 199 mg/dl;
| Estimated Enrollment: | 300 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2017 |
| Estimated Primary Completion Date: | August 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Insulin treatment for hyperglycemia
Table 1. NPH Insulin Titration Regimen for Patients in Group A Pre-dinner Capillary blood glucose NPH dose initiation (IU/day) NPH dose adjustment(IU/day) > 240 mg/dl 14 Increase by 4 > 180 mg/dl 12 Increase by 4 > 140 mg/dl 10 Increase by 4 > 120 mg/dl 0 Increase by 2 100 to 119 mg/dl 0 Maintain the dose 80 - <100 mg/dl 0 Decrease by 4 60 - <80 mg/dl 0 Decrease by 8 < 60 mg/dl 0 Give ½ of previous dose
|
Drug: Insulin treatment for hyperglycemia |
|
No Intervention: Standard of care
Patients assigned in this arm will receive standard of care following their kidney transplantation.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult patients (> 18 years) with ESRD undergoing kidney transplantation;
- Standard triple immunosuppressive medications following kidney transplantation including tacrolimus, mycophenolate moftile and corticosteroids;
- Capable to understand the study protocol and to give informed consent;
Exclusion Criteria:
1. Type 1 and 2 DM either as co-morbidity or cause of ESRD;
Contacts and Locations| United States, Michigan | |
| University of Michigan | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Fu L Luan, MD 734-763-9031 fluan@med.umich.edu | |
| Contact: Jill E Seary, RN 734 936 4811 jseary@med.umich.edu | |
More Information
No publications provided
| Responsible Party: | Fu L Luan, Clinical Associate Professor, University of Michigan |
| ClinicalTrials.gov Identifier: | NCT01683331 History of Changes |
| Other Study ID Numbers: | 1R01DK092475-01 |
| Study First Received: | August 30, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Michigan:
|
Kidney transplant New onset diabetes Prevention Insulin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013