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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

Tracking Information
First Submitted Date September 18, 2008
First Posted Date September 22, 2008
Results First Submitted Date April 24, 2018
Results First Posted Date June 11, 2019
Last Update Posted Date June 19, 2019
Actual Study Start Date February 1, 2008
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 7, 2019)
The Long Term Effect of Intensive Glycemic Control in Type 2 Diabetes on Major Cardiovascular Complication. [ Time Frame: 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).
Original Primary Outcome Measures
 (submitted: September 19, 2008)
To determine the long term effect of intensive glycemic control in type 2 diabetes on major cardiovascular complication. [ Time Frame: Nine years. ]
Change History
Current Secondary Outcome Measures
 (submitted: June 7, 2019)
  • The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Total Mortality. [ Time Frame: 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.
  • The Long Term Effects of Intensive Glycemic Control in Type 2 Diabetes on the Secondary Outcome Cardiovascular Mortality. [ Time Frame: 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.
  • Number of Events on Major Microvascular or Macrovascular Outcome [ Time Frame: 15 years ]
    End-stage renal disease, amputation for either ischemic or non-ischemic gangrene, CV-related death, or nonfatal MI, stroke, or new CHF.
  • Patients Reported Health Related Quality of Life [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: September 19, 2008)
2.To determine the long term effects of intensive glycemic control in type 2 diabetes on four secondary outcomes: a) cardiovascular mortality, b) major microvascular complications, c) health-related quality of life, and d) total mortality. [ Time Frame: Nine years. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The VA Diabetes Trial Follow-up Study (VADT-FS)
Official Title CSP #465FS - VA Diabetes Trial Long Term Follow-up Study
Brief Summary

CSP #465, "Glycemic Control and Complications in Diabetes Mellitus Type 2," was a randomized unblinded clinical trial comparing tight glycemic control to standard glycemic control. Tight glycemic control consisted of giving patients appropriate diabetic medications to lower the patient's HbA1c to around 7%, whereas standard control attempted to lower the patient's HbA1c to between 8% and 9%. The study was conducted at 20 VA medical centers. 1791 patients were randomized over the 2 year accrual period and then followed for an additional 5 years. Follow-up averaged between 5 and 7 years depending upon when the patient was enrolled in the study. Patients were seen on average every three months in the VA Outpatient Clinics. High blood pressure and elevated cholesterol were aggressively treated in patients in both treatment arms. Education regarding diet, exercise, smoking cessation and management of very high and very low glucose was also provided. Data were collected throughout the study on the patients' physical status, adverse and serious adverse events, concomitant medications, and study end points including mortality, heart attack, stroke and surgery to fix the arteries in the heart, legs or neck. The study consisted of broad use of all anti-diabetic treatments commercially available between 2000 and 2008 including oral medications and insulin. Study required medications and all study clinic visits were provided free of the usual VA co-pay. Active clinical follow-up of the sample ended on May 31, 2008. With the end of the clinical trial the patients were transitioned back to usual patient care services, treatment regimens were adjusted where appropriate and future treatment will be dictated by the patient's health and his/her health care provider.

It is important to clarify that with the completion of the active clinical trial and transitioning of patients to this observational trial, all responsibility for the care, treatment and oversight of the study patients will become the responsibility of the patients' Primary Care Physician. The Long Term Follow-up will not collect adverse or serious adverse events, or actively treat or have any "hands-on" care responsibility for the study participants.

The proposed Long Term Follow-up Study will consist of centralized computer database searches and annual survey questionnaires related to quality of life and self-reported events pertinent to the CSP #465 study.

Detailed Description

Diabetes mellitus is a major health problem in the U.S., especially in the VA population. The majority of diabetics are Type 2, and they are at risk for microvascular (e.g. eye, kidney) and macrovascular (e.g. cardiovascular) complications. It is probable that many of the macrovascular and microvascular complications potentially prevented by the 5-7 years of good Glycemic control achieved in the VADT (median follow-up 6.25 years) will occur years after completion of the VADT experimental protocol. This follow-up study will provide the opportunity to see if this holds true up to 9 years following the end of 465.

The results will help the VA in evaluating most appropriate treatments and costs of such treatment.

This is a longitudinal observational follow-up study of CSP #465, "Glycemic Control and Complications in Diabetes Mellitus Type 2",the VA Diabetes Trial (VADT) NCT #00032487. The objectives are: 1) to determine the long term effects of intensive glycemic control in type 2 diabetes on major cardiovascular complications (primary outcome), and 2) to determine the long term effects of intensive glycemic control in type 2 diabetes on four secondary outcomes: a) cardiovascular mortality, b) major microvascular complications, c) health-related quality of life, and d) total mortality.

All patients active at the end of VADT will be approached for participation in VADT-FS. The only exclusion reason will be failure to receive consent for participation. Consented VADT-FS patients will be followed until the end of the study unless they withdraw their consent. Patients will be sent a short, standardized self-administered survey annually. Information collected will include: 1) self-reported health status; 2) occurrence of study endpoints; and 3) VA or non-VA outpatient visits, hospitalizations and procedures. A variety of data sources will be searched to verify endpoints. These sources include: 1) VA and non-VA medical records; 2) data from the Centers for Medicare and Medicaid Services (CMS); and 3) VA and US death records. Patients who do not respond to 3 mailed surveys will be contacted by phone.

If still unsuccessful, their designated surrogate will be contacted. Certain endpoints will be adjudicated by the same committee that was utilized by VADT. Endpoints that will be adjudicated will include: 1) cause of death; 2) reason for amputation; and 3) cardiac-related non-VA hospitalizations. Endpoints of interest in this study include: 1) mortality; 2) acute myocardial infarction requiring hospitalization; 3) stroke; 4) new onset congestive heart failure; 5) coronary revascularization; 6) amputation; 7) peripheral revascularization; 8) renal insufficiency; 9) severe visual impairment; and 10) self-reported health status (diabetes-related quality of life).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population To be eligible for the VADT, subjects had to be over 40 years old, have type 2 diabetes and be non-responsive (A1c > 7.5%) to a maximum daily dose of one or more oral agents or on insulin. And to participate in the VADT-FS the participant had to be active in the VADT study.
Condition
  • Diabetes
  • Glycemic Control
Intervention Not Provided
Study Groups/Cohorts 465 VADT participants
The participants had previously participated in the VADT CSP #465 study
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 2, 2017)
1044
Original Estimated Enrollment
 (submitted: September 19, 2008)
1350
Actual Study Completion Date December 31, 2017
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients active at the end of VADT will be approached for participation.

Exclusion Criteria:

  • The only exclusion criterion will be failure to achieve consent for continued participation.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00756613
Other Study ID Numbers 465FS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party VA Office of Research and Development
Original Responsible Party Abraira, Carlos - Study Chair, Department of Veterans Affairs
Current Study Sponsor VA Office of Research and Development
Original Study Sponsor US Department of Veterans Affairs
Collaborators Not Provided
Investigators
Study Chair: Peter D Reaven, MD Phoenix VA Health Care System, Phoenix, AZ
Study Chair: Nicholas Emanuele, MD Hines VAMC, Hines IL
PRS Account VA Office of Research and Development
Verification Date June 2019