Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by University of Michigan.
NCT01683331 is a Phase 4 study that has completed, run by University of Michigan. The registered enrollment target is 251 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
What the finished NCT01683331 record still lists
NCT01683331 is an interventional study that assigns participants to a tested intervention. The registered 251 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which Insulin treatment for hyperglycemia is the first listed.
NCT01683331 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01683331's enrollment target sits among peer trials
251 342nd of 2000 higher than 1,659 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06043817 · 251 participants · Phase 1
First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations
- NCT02314988 · 252 participants · Phase 2
Tranexamic Acid to Reduce Blood Loss in Spine Surgery
- NCT03941756 · 252 participants · NA
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
- NCT05219617 · 252 participants · Phase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia