We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The VA Diabetes Trial Follow-up Study (VADT-FS) (VADT-F)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00756613
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : June 11, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Conditions Diabetes
Glycemic Control
Enrollment 1044
Recruitment Details All alive VADT study subjects were approached for participation in the VADT-FS.
Pre-assignment Details  
Arm/Group Title 465 VADT Participants - Standard 465 VADT Participants - Intensive
Hide Arm/Group Description The participants had previously participated in the VADT trial in the standard of care group. The participants had previously participated in the VADT CSP #465 study in the intensive treatment group.
Period Title: Overall Study
Started 512 532
Completed 426 462
Not Completed 86 70
Arm/Group Title 465 VADT Participants - Standard 465 VADT Participants -Intensive Total
Hide Arm/Group Description The participants had previously participated in the VADT CSP #465 study The participants had previously participated in the VADT CSP #465 study Total of all reporting groups
Overall Number of Baseline Participants 512 532 1044
Hide Baseline Analysis Population Description
In the original study VADT (NCT00032487) there were 1791 patients, however in the follow-up study there were only 1044 patients consented from the 1791in the VADT study. The patients that did not enter the follow-up study either refused to consent to 465 follow-up study, or died, or withdrew from the original study.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 532 participants 1044 participants
<=18 years 0 0 0
Between 18 and 65 years 354 393 747
>=65 years 158 139 297
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 512 participants 532 participants 1044 participants
60.1  (8.3) 59.5  (8.0) 59.8  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 532 participants 1044 participants
Female
14
   2.7%
18
   3.4%
32
   3.1%
Male
498
  97.3%
514
  96.6%
1012
  96.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 532 participants 1044 participants
Hispanic or Latino
95
  18.6%
113
  21.2%
208
  19.9%
Not Hispanic or Latino
417
  81.4%
419
  78.8%
836
  80.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 512 participants 532 participants 1044 participants
American Indian or Alaska Native
3
   0.6%
6
   1.1%
9
   0.9%
Asian
2
   0.4%
5
   0.9%
7
   0.7%
Native Hawaiian or Other Pacific Islander
2
   0.4%
1
   0.2%
3
   0.3%
Black or African American
89
  17.4%
91
  17.1%
180
  17.2%
White
409
  79.9%
418
  78.6%
827
  79.2%
More than one race
7
   1.4%
11
   2.1%
18
   1.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Long Term Effect of Intensive Glycemic Control in Type 2 Diabetes on Major Cardiovascular Complication.
Hide Description 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).
Time Frame 15 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 465 VADT Participants - Standard 465 VADT Participants -Intensive
Hide Arm/Group Description:
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
Overall Number of Participants Analyzed 899 892
Measure Type: Number
Unit of Measure: number of events
336 325
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 465 VADT Participants - Standard, 465 VADT Participants -Intensive
Comments To determine the long term effects of intensive glycemic control in type 2 diabetes on major cardiovascular events.
Type of Statistical Test Equivalence
Comments We considered a 20% reduction in primary events to be a reasonable goal of intensive glycemic control over the anticipated 15-year study time period. This effect size was chosen by taking into consideration both the probability of observing an effect of that size given the level of achieved A1c separation, and the perceived value to the patient of this level of benefit relative to the risk and burden of intensive glycemic control.
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.78 to 1.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Total Mortality.
Hide Description 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.
Time Frame 15 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 465 VADT Participants - Standard 465 VADT Participants -Intensive
Hide Arm/Group Description:
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
Overall Number of Participants Analyzed 899 892
Measure Type: Count of Participants
Unit of Measure: Participants
366
  40.7%
376
  42.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 465 VADT Participants - Standard, 465 VADT Participants -Intensive
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The equivalence margin is expected 20% reduction for the intensive treatment group compared to the standard treatment group.
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.88 to 1.18
Estimation Comments [Not Specified]
3.Secondary Outcome
Title The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Cardiovascular Mortality.
Hide Description 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.
Time Frame 15 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 465 VADT Participants - Standard 465 VADT Participants -Intensive
Hide Arm/Group Description:
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
Overall Number of Participants Analyzed 899 892
Measure Type: Count of Participants
Unit of Measure: Participants
125
  13.9%
118
  13.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 465 VADT Participants - Standard, 465 VADT Participants -Intensive
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The equivalence margin is 20% reduction of intensive treatment group versus standard treatment group.
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.67 to 1.20
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Events on Major Microvascular or Macrovascular Outcome
Hide Description End-stage renal disease, amputation for either ischemic or non-ischemic gangrene, CV-related death, or nonfatal MI, stroke, or new CHF.
Time Frame 15 years
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 465 VADT Participants - Standard 465 VADT Participants -Intensive
Hide Arm/Group Description:
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in standard treatment group.
The participants had previously participated in the VADT Cooperative Studies Program (CSP) #465 study in the intensive group.
Overall Number of Participants Analyzed 899 892
Measure Type: Number
Unit of Measure: events
355 342
5.Secondary Outcome
Title Patients Reported Health Related Quality of Life
Hide Description 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.
Time Frame 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
T-test for comparing between the two treatment groups using the average of last two responses of the surveys.
Arm/Group Title 465 VADT Participants - Standard 465 VADT Participants -Intensive
Hide Arm/Group Description:
The participants had only participated in the VADT Cooperative Studies Program Follow-up #465-F study in standard treatment group.
The participants had only participated in the VADT Cooperative Studies Program Follow-up #465-F study in the intensive group.
Overall Number of Participants Analyzed 449 470
Mean (Standard Deviation)
Unit of Measure: score on a scale
62.2  (17.6) 63.8  (17.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 465 VADT Participants - Standard, 465 VADT Participants -Intensive
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments T-test comparing between the two groups of treatment using the average score of last two surveys.
Statistical Test of Hypothesis P-Value 0.172
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.61
Estimation Comments [Not Specified]
Time Frame The VA Diabetes Trial Follow-up Study (VADT-FS) has not collected adverse or serious adverse events, is not required to file FDA reports or actively treat or have any "hands-on" care responsibility for the study participants.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title [Not Specified]
Hide Arm/Group Description serious and other [non-serious] adverse events were not collected or assessed as part of the study
All-Cause Mortality
[Not Specified]
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
[Not Specified]
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
[Not Specified]
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tamara Paine
Organization: VA
Phone: 7082028387 ext 25785
EMail: tamara.paine@va.gov
Publications of Results:
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00756613    
Other Study ID Numbers: 465FS
First Submitted: September 18, 2008
First Posted: September 22, 2008
Results First Submitted: April 24, 2018
Results First Posted: June 11, 2019
Last Update Posted: June 19, 2019