Trial · NCT00756613
The VA Diabetes Trial Follow-up Study (VADT-FS)
NCT00756613, Completed, VA Office of Research and Development; results first posted 2019-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The VA Diabetes Trial Follow-up Study (VADT-FS). Trials, record NCT00756613. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00756613
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The VA Diabetes Trial Follow-up Study (VADT-FS)
- NCT number
- NCT00756613
- Status
- Completed
- Enrollment
- 1,044 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Diabetes, Glycemic Control
- First posted
- 2008-09-22
- Last updated
- 2019-06-19
- Results first posted
- 2019-06-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Long Term Effect of Intensive Glycemic Control in Type 2 Diabetes on Major Cardiovascular Complication. | 15 years | Major CV events (non-fatal MI resulting in hospitalization, non-fatal stroke, new Congestive Heart Failure (CHF), amputation for ischemic diabetic gangrene, or CV-related death). |
| Secondary | The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Total Mortality. | 15 years | The major secondary end-point of cardiovascular (CV) mortality will measure the cause of death (end-stage renal disease, amputation for either ischemic or non-ischemic gangrene, CV-related death, or nonfatal myocardial infarction (MI), stroke, or new congestive heart failure (CHF)) retrieved by the National Death Index (NDI). Survival analysis will analyzed by time of event to death. |
| Secondary | The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Cardiovascular Mortality. | 15 years | The major secondary end-point of total mortality will measure all deaths with data retrieved from VA Information Resource Center (VIREC) Cooperate Data Warehouse (CDW) . Survival analysis will analyzed by time to death. |
| Secondary | Number of Events on Major Microvascular or Macrovascular Outcome | 15 years | End-stage renal disease, amputation for either ischemic or non-ischemic gangrene, CV-related death, or nonfatal MI, stroke, or new CHF. |
| Secondary | Patients Reported Health Related Quality of Life | 9 years | Self-reported health status using an instrument adapted for type 2 diabetes mellitus patients from the Diabetes Control and Complications Trial (DCCT) (Duckworth, 1998; Saudek 1996). This survey tool has been used since the inception of the VADT and will be continued in the annual survey. The minimum value is 0 and the maximum value is 100. The higher score is a better outcome. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Long Term Effect of Intensive Glycemic Control in Type 2 Diabetes on Major Cardiovascular Complication. | 15 years | Total number of participants reflect all that participated in the VA Cooperative Studies Program (CSP) #465 study, Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) NCT00032487, but censored those who refused to consent to 465 follow-up study or died or withdrew from the study. | number of events | NUMBER |
| SECONDARY | The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Total Mortality. | 15 years | Total number of participants reflect all that participated in the VA Cooperative Studies Program (CSP) #465 study, Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) NCT00032487, but censored those who refused to consent to 465 follow-up study or died or withdrew from the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Cardiovascular Mortality. | 15 years | Total number of participants reflect all that participated in the VA Cooperative Studies Program (CSP) #465 study, Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)NCT00032487, but censored those who refused to consent to 465 follow-up study or died or withdrew from the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Events on Major Microvascular or Macrovascular Outcome | 15 years | Total number of participants reflect all that participated in the VA Cooperative Studies Program (CSP) #465 study, Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT) NCT00032487, but censored those who refused to consent to 465 follow-up study or died or withdrew from the study. | events | NUMBER |
| SECONDARY | Patients Reported Health Related Quality of Life | 9 years | T-test for comparing between the two treatment groups using the average of last two responses of the surveys. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Long Term Effect of Intensive Glycemic Control in Type 2 Diabetes on Major Cardiovascular Complication. | 465 VADT Participants - Standard | 336 | number of events | ||
| The Long Term Effect of Intensive Glycemic Control in Type 2 Diabetes on Major Cardiovascular Complication. | 465 VADT Participants -Intensive | 325 | number of events | ||
| The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Total Mortality. | 465 VADT Participants - Standard | 366 | Participants | ||
| The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Total Mortality. | 465 VADT Participants -Intensive | 376 | Participants | ||
| The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Cardiovascular Mortality. | 465 VADT Participants - Standard | 125 | Participants | ||
| The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Cardiovascular Mortality. | 465 VADT Participants -Intensive | 118 | Participants | ||
| Number of Events on Major Microvascular or Macrovascular Outcome | 465 VADT Participants - Standard | 355 | events | ||
| Number of Events on Major Microvascular or Macrovascular Outcome | 465 VADT Participants -Intensive | 342 | events | ||
| Patients Reported Health Related Quality of Life | 465 VADT Participants - Standard | 62.2 | Standard Deviation 17.6 | score on a scale | |
| Patients Reported Health Related Quality of Life | 465 VADT Participants -Intensive | 63.8 | Standard Deviation 17.2 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 465 VADT Participants - Standard | 512 | |
| Overall Study | STARTED | 465 VADT Participants - Intensive | 532 | |
| Overall Study | COMPLETED | 465 VADT Participants - Standard | 426 | |
| Overall Study | COMPLETED | 465 VADT Participants - Intensive | 462 | |
| Overall Study | NOT COMPLETED | 465 VADT Participants - Standard | 86 | |
| Overall Study | NOT COMPLETED | 465 VADT Participants - Intensive | 70 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0 | 0 | |
| Total, other adverse events | 0 | 0 | |
| Total, serious adverse events | 0 | 0 |
Source ClinicalTrials.gov
Papers17
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 465 VADT Participants - Standard vs 465 VADT Participants -Intensive: The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Cardiovascular Mortality. | Trial comparisons |
| 465 VADT Participants - Standard vs 465 VADT Participants -Intensive: The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Total Mortality. | 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/NCT00756613
GET https://conductscience.org/api/trials/v1/NCT00756613/registered