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NCT01683331 · ClinicalTrials.gov registry record · Phase 4
A Clinical Trial to Prevent New Onset Diabetes After Transplantation
A Phase 4 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 4
- Development phase
- 251
- Enrollment target
NCT01683331 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 251 participants.
The verdict
NCT01683331, a Phase 4 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 251 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Insulin treatment for hyperglycemia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2012-08 |
| Est. Completion | 2018-02-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01683331
The ClinicalTrials.gov registry entry for NCT01683331 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 251 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Insulin treatment for hyperglycemia is the first listed.
NCT01683331 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01683331 about?
NCT01683331 is a clinical study titled "A Clinical Trial to Prevent New Onset Diabetes After Transplantation". 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 insuli...
What is the current status of trial NCT01683331?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 251 participants. The study started on 2012-08. Estimated completion is 2018-02-27.
What interventions are being tested in trial NCT01683331?
The interventions under investigation include: Insulin treatment for hyperglycemia (DRUG).
Who is sponsoring clinical trial NCT01683331?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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