Trial Outcomes & Findings for The VA Diabetes Trial Follow-up Study (VADT-FS) (NCT NCT00756613)
NCT ID: NCT00756613
Last Updated: 2019-06-19
Results Overview
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).
COMPLETED
1044 participants
15 years
2019-06-19
Participant Flow
All alive VADT study subjects were approached for participation in the VADT-FS.
Participant milestones
| Measure |
465 VADT Participants - Standard
The participants had previously participated in the VADT trial in the standard of care group.
|
465 VADT Participants - Intensive
The participants had previously participated in the VADT CSP #465 study in the intensive treatment group.
|
|---|---|---|
|
Overall Study
STARTED
|
512
|
532
|
|
Overall Study
COMPLETED
|
426
|
462
|
|
Overall Study
NOT COMPLETED
|
86
|
70
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The VA Diabetes Trial Follow-up Study (VADT-FS)
Baseline characteristics by cohort
| Measure |
465 VADT Participants - Standard
n=512 Participants
The participants had previously participated in the VADT CSP #465 study
|
465 VADT Participants -Intensive
n=532 Participants
The participants had previously participated in the VADT CSP #465 study
|
Total
n=1044 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
498 Participants
n=99 Participants
|
514 Participants
n=107 Participants
|
1012 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
95 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
208 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
417 Participants
n=99 Participants
|
419 Participants
n=107 Participants
|
836 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
354 Participants
n=99 Participants
|
393 Participants
n=107 Participants
|
747 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
158 Participants
n=99 Participants
|
139 Participants
n=107 Participants
|
297 Participants
n=206 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
59.5 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
59.8 years
STANDARD_DEVIATION 8.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
89 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
180 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
409 Participants
n=99 Participants
|
418 Participants
n=107 Participants
|
827 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 15 yearsPopulation: 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.
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).
Outcome measures
| Measure |
465 VADT Participants - Standard
n=899 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
|
465 VADT Participants -Intensive
n=892 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
|
|---|---|---|
|
The Long Term Effect of Intensive Glycemic Control in Type 2 Diabetes on Major Cardiovascular Complication.
|
336 number of events
|
325 number of events
|
SECONDARY outcome
Timeframe: 15 yearsPopulation: 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.
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.
Outcome measures
| Measure |
465 VADT Participants - Standard
n=899 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
|
465 VADT Participants -Intensive
n=892 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
|
|---|---|---|
|
The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Total Mortality.
|
366 Participants
|
376 Participants
|
SECONDARY outcome
Timeframe: 15 yearsPopulation: 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.
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.
Outcome measures
| Measure |
465 VADT Participants - Standard
n=899 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
|
465 VADT Participants -Intensive
n=892 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
|
|---|---|---|
|
The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Cardiovascular Mortality.
|
125 Participants
|
118 Participants
|
SECONDARY outcome
Timeframe: 15 yearsPopulation: 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.
End-stage renal disease, amputation for either ischemic or non-ischemic gangrene, CV-related death, or nonfatal MI, stroke, or new CHF.
Outcome measures
| Measure |
465 VADT Participants - Standard
n=899 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
|
465 VADT Participants -Intensive
n=892 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
|
|---|---|---|
|
Number of Events on Major Microvascular or Macrovascular Outcome
|
355 events
|
342 events
|
SECONDARY outcome
Timeframe: 9 yearsPopulation: T-test for comparing between the two treatment groups using the average of last two responses of the surveys.
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.
Outcome measures
| Measure |
465 VADT Participants - Standard
n=449 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
|
465 VADT Participants -Intensive
n=470 Participants
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
|
|---|---|---|
|
Patients Reported Health Related Quality of Life
|
62.2 score on a scale
Standard Deviation 17.6
|
63.8 score on a scale
Standard Deviation 17.2
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place