Trial · NCT00609986
IV Insulin Protocol in Diabetes and Renal Transplantation
NCT00609986, Not applicable, Completed, Medical University of South Carolina; results first posted 2013-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IV Insulin Protocol in Diabetes and Renal Transplantation. Trials, record NCT00609986. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00609986
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IV Insulin Protocol in Diabetes and Renal Transplantation
- NCT number
- NCT00609986
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 104 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Kidney Transplantation, Diabetes, Hyperglycemia
- Interventions
- insulin, NPH Insulin or glargine insulin and aspartame insulin
- First posted
- 2008-02-07
- Last updated
- 2013-09-06
- Results first posted
- 2013-08-07
- Limitations and caveats
- A limitation of the trial was that the majority of the patients enrolled in the study were African American, and therefore the findings cannot be extended to groups of other ethnic groups.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Delayed Graft Function | 10 days | Need for dialysis in the first week post-transplant in a patient who required dialysis pre-transplantation or day-10 post-transplant creatinine concentration above 2.5 mg/dl. |
| Primary | Acute/Active Rejection | 30 months | Grades IA through III and antibody immediate rejection, either A (immediate or hyperacute) or B (delayed or accelerated acute) were diagnosed and classified based on renal allograft biopsies according to the Banff 97 Working Classification of Renal Allograph Pathology. |
| Secondary | Severe Hypoglycemia | 30 months | Blood glucose less than 40 mg/dl |
| Secondary | Severe Hyperglycemia | 30 months | Blood glucose greater than 350 mg/dl. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Delayed Graft Function | 10 days | The intent-to-treat analysis set consisted of the participants that underwent a renal transplant. | participants | NUMBER |
| SECONDARY | Severe Hypoglycemia | 30 months | The intent-to-treat analysis set consisted of the participants that underwent a renal transplant. | participants | NUMBER |
| PRIMARY | Acute/Active Rejection | 30 months | The intent-to-treat analysis set consisted of the participants that underwent a renal transplant. | participants | NUMBER |
| SECONDARY | Severe Hyperglycemia | 30 months | The intent-to-treat analysis set consisted of the participants that underwent a renal transplant. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Delayed Graft Function | Intensive | 8 | participants | ||
| Delayed Graft Function | Control | 12 | participants | ||
| Severe Hypoglycemia | Intensive | 7 | participants | ||
| Severe Hypoglycemia | Control | 2 | participants | ||
| Acute/Active Rejection | Intensive | 9 | participants | ||
| Acute/Active Rejection | Control | 2 | participants | ||
| Severe Hyperglycemia | Intensive | 5 | participants | ||
| Severe Hyperglycemia | Control | 12 | participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intensive | 52 | |
| Overall Study | STARTED | Control | 52 | |
| Overall Study | Received Transplant | Intensive | 44 | |
| Overall Study | Received Transplant | Control | 49 | |
| Overall Study | COMPLETED | Intensive | 44 | |
| Overall Study | COMPLETED | Control | 49 | |
| Overall Study | NOT COMPLETED | Intensive | 8 | |
| Overall Study | NOT COMPLETED | Control | 3 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | severe hypoglycemia | Endocrine disorders | Intensive | 7 | 44 | 8 |
| other | severe hypoglycemia | Endocrine disorders | Control | 2 | 49 | 2 |
| other | severe hyperglycemia | Endocrine disorders | Intensive | 5 | 44 | 5 |
| other | severe hyperglycemia | Endocrine disorders | Control | 12 | 49 | 25 |
| serious | renal graft thrombosis | Renal and urinary disorders | Intensive | 0 | 44 | 0 |
| serious | renal graft thrombosis | Renal and urinary disorders | Control | 1 | 49 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Intensive | ||
| Total, all-cause mortality | Control | ||
| Total, other adverse events | Intensive | 12 | 44 |
| Total, other adverse events | Control | 14 | 49 |
| Total, serious adverse events | Intensive | 0 | 44 |
| Total, serious adverse events | Control | 1 | 49 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Intensive vs Control: Severe Hypoglycemia | Trial comparisons |
| Intensive vs Control: Acute/Active Rejection | Trial comparisons |
| Intensive vs Control: Severe Hyperglycemia | Trial comparisons |
| Intensive vs Control: Delayed Graft Function | Trial comparisons |
| Intensive vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00609986
GET https://conductscience.org/api/trials/v1/NCT00609986/registered