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| Name | Class |
|---|---|
| Medical University of Vienna | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin treatment for hyperglycemia | Active Comparator | 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. |
|
| Standard of care | No Intervention | Patients assigned in this arm will receive standard of care following their kidney transplantation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin treatment for hyperglycemia | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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; | 6, 12 and 24 months |
Inclusion Criteria:
Exclusion Criteria:
1. Type 1 and 2 Diabetes Mellitus (DM) either as co-morbidity or cause of ESRD;
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| Name | Affiliation | Role |
|---|---|---|
| Akinlolu Ojo, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
Of 42 participants randomized prior to kidney transplantation at University of Michigan, 6 did not undergo study procedure due to medical conditions that developed in the immediate postoperative period which prevented them from going forward in the study. Data are not available on the 209 participants randomized through the University of Austria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Treatment for Hyperglycemia | 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. |
| FG001 | Standard of Care | Patients assigned in this arm will receive standard of care following their kidney transplantation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Treatment for Hyperglycemia | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Count of Participants | Participants | 12 months |
|
24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Treatment for Hyperglycemia | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
The original trial design was to include 250 participants. Data from the Austrian site has not been provided to the PI, thus limiting the analysis to a much smaller population.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Akinlolu Ojo | University of Michigan | 734 936-4890 | aojo@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2017 | Feb 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 24 months |
| BG001 | Standard of Care | Patients assigned in this arm will receive standard of care following their kidney transplantation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Standard of Care | Patients assigned in this arm will receive standard of care following their kidney transplantation. |
|
|
|
| Secondary | 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:
| Posted | Count of Participants | Participants | 24 months |
|
|
|
|
| Other Pre-specified | 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; | Not Posted | 6, 12 and 24 months | Participants |
| 0 |
| 18 |
| 15 |
| 18 |
| 15 |
| 18 |
| EG001 | Standard of Care | Patients assigned in this arm will receive standard of care following their kidney transplantation. | 0 | 18 | 10 | 18 | 14 | 18 |
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Low Vitamin D | Endocrine disorders | Systematic Assessment |
|
| Nausea/Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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