A Phase 4 interventional study of Insulin treatment for hyperglycemia in Prevention of New Onset Diabetes Among Kidney Transplant Patients, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-20.
Sponsored by University of Michigan · Phase 4, Interventional, and Prevention
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 251 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Exclusion Criteria:
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.
Drug: Insulin treatment for hyperglycemia
Patients assigned in this arm will receive standard of care following their kidney transplantation.
The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation
NODAT will be defined according to American Diabetes Association definition: 1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or 2. 2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or 3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or 4. On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria.
Time frame: 12 months
The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation
NODAT will be defined according to American Diabetes Association definition: 1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or 2. 2 hours OGTT values equal or greater than 200 mg/dl; and/or 3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or 4. On oral hypoglycemic agents and/or insulin therapy;
Time frame: 24 months
Incidence of Impaired Fasting Glycemia and Impaired Glucose Tolerance 6, 12 and 24 Months After Transplantation.
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;
Time frame: 6, 12 and 24 months
| Milestone | Insulin Treatment for Hyperglycemia | Standard of Care |
|---|---|---|
| Started | 18 | 18 |
| Began dosage | 18 | 18 |
| 12 months | 18 | 18 |
| 24 months | 18 | 18 |
| Completed | 18 | 18 |
| Not completed | 0 | 0 |
NODAT will be defined according to American Diabetes Association definition: 1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or 2. 2 hours Oral Glucose Tolerance Test (OGTT) values equal or greater than 200 mg/dl; and/or 3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or 4. On oral hypoglycemic agents and/or insulin therapy; Incidence is measured in terms of number of participants who meet any of these 4 criteria.
| Participants | Insulin Treatment for Hyperglycemia | Standard of Care |
|---|---|---|
| The Incidence of New Onset of Diabetes After Transplant (NODAT) 12 Months After Kidney Transplantation | 3 | 1 |
NODAT will be defined according to American Diabetes Association definition: 1. Fasting glucose level equal or greater than 126 mg/dl on two separate blood testings; and/or 2. 2 hours OGTT values equal or greater than 200 mg/dl; and/or 3. Glycosylated hemoglobin A1c equal or greater than 6.5; and/or 4. On oral hypoglycemic agents and/or insulin therapy;
| Participants | Insulin Treatment for Hyperglycemia | Standard of Care |
|---|---|---|
| The Incidence of New Onset of Diabetes After Transplant (NODAT) 24 Months After Kidney Transplantation | 1 | 0 |
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;
Results for this outcome have not been posted.
Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Treatment for Hyperglycemia | 0/18 (0%) | 15/18 (83.3%) | 15/18 (83.3%) |
| Standard of Care | 0/18 (0%) | 10/18 (55.6%) | 14/18 (77.8%) |
| Event | Insulin Treatment for Hyperglycemia | Standard of Care |
|---|---|---|
| Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders | 9/18 | 8/18 |
| Urinary Tract InfectionRenal and urinary disorders | 6/18 | 4/18 |
| Event | Insulin Treatment for Hyperglycemia | Standard of Care |
|---|---|---|
| DiarrheaGastrointestinal disorders | 13/18 | 10/18 |
| Low Vitamin DEndocrine disorders | 3/18 | 9/18 |
| AnemiaBlood and lymphatic system disorders | 8/18 | 6/18 |
| Nausea/VomitingGastrointestinal disorders | 8/18 | 7/18 |
| Abdominal PainGastrointestinal disorders | 7/18 | 3/18 |
| HypertensionCardiac disorders | 3/18 | 7/18 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 6/18 | 1/18 |
| Age, Continuous(years) | Insulin Treatment for Hyperglycemia | Standard of Care | Total |
|---|---|---|---|
| Mean | 52.6 ± 13.9 | 44.6 ± 15.5 | 48.6 ± 15.1 |
| Sex: Female, Male(Participants) | Insulin Treatment for Hyperglycemia | Standard of Care | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 8 | 8 | 16 |
| Ethnicity (NIH/OMB)(Participants) | Insulin Treatment for Hyperglycemia | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 17 | 16 | 33 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Insulin Treatment for Hyperglycemia | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 1 | 6 |
| White | 13 | 16 | 29 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Insulin Treatment for Hyperglycemia | Standard of Care | Total |
|---|---|---|---|
| United States | 18 | 18 | 36 |
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