CSP #465: VA Diabetes Trial (VADT) and CSP #465-F: VA Diabetes Trial Follow-up Study (VADT-FS) - VA Cooperative Studies Program (CSP)
Attention A T users. To access the menus on this page please perform the following steps. 1. Please switch auto forms mode to off. 2. Hit enter to expand a main menu option (Health, Benefits, etc). 3. To enter and activate the submenu links, hit the down arrow. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links.

VA Cooperative Studies Program (CSP)

Menu
Menu

Quick Links

Veterans Crisis Line Badge
My healthevet badge
EBenefits Badge
 

CSP #465: VA Diabetes Trial (VADT) and CSP #465-F: VA Diabetes Trial Follow-up Study (VADT-FS)

Main Study:
CSP #465: VA Diabetes Trial (VADT)

Official title: Glycemic Control and Complications in Diabetes Mellitus Type 2 


Follow-Up Study:   
CSP #465-F: VA Diabetes Trial Follow-up Study (VADT-FS)
  

Data Sharing Statement
CSP #465

What's available

Pending

Available Documentation 

Pending

Dates Data are Available 

Pending

Access Criteria

Pending

Study Characteristics
CSP #465

Objectives

  • To determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 diabetes mellitus who are no longer responsive to oral agents alone
  • To evaluate the effects on microangiopathy, quality of life, and cost effectiveness

Era of Service

All

Population

Patients with type 2 diabetes mellitus who were over age 40 and had inadequate glycemic control, defined as a baseline HbA1c of ≥7.5% on maximal dose of at least one oral anti-hyperglycemic agent or on insulin

Study Design 

Randomized, unblinded clinical trial 

Intervention 

  • Arm 1: Standard glycemic control – diabetes medications (insulin, Glimepiride, Rosiglitazone, and Metformin) with the therapeutic goal to lower the patient's HbA1c to between 8% and 9%
  • Arm 2: Tight glycemic control – diabetes medications with the therapeutic goal to lower HbA1c to below 6%

Time Period 

December 2000 - May 2008

Setting 

National 

1,791

Response Rate

Pending

Recruitment Method

Patients screened for eligibility at twenty VA medical centers

Compensation

Pending

Data Collected

  • Demographic characteristics
  • Clinical characteristics such as time since diabetes mellitus diagnosis, concomitant medications, weight, body mass index, blood pressure, cholesterol, smoking status
  • Occurrence of study primary endpoints: acute myocardial infarction, death from cardiovascular disease, stroke, congestive, heart failure, amputation from peripheral vascular disease (PVD), surgical intervention for coronary or PVD, and critical limb ischemia
  • Occurrence of study secondary endpoints: angina, claudication, retinopathy, nephropathy, neuropathy, quality of life, cognitive function, and cost-effectiveness

Data Collection Methods

  • Medical records
  • Clinical visits

Funding Source

  • VA Cooperative Studies Program (CSP)
  • American Diabetes Association
  • National Eye Institute
  • GlaxoSmithKline
  • Novo Nordisk
  • Roche Diagnostics
  • Sanofi-Aventis
  • Amylin
  • Kos Pharmaceuticals

Contact 

Gideon.Bahn@va.gov  

Selected Publications 

Duckworth W, Abraira C, Moritz T, Reda D, Emanuele N, Reaven PD, Zieve FJ, Marks J, Davis SN, Hayward R, Warren SR, Goldman S, McCarren M, Vitek ME, Henderson WG, Huang GD; VADT Investigators. Glucose control and vascular complications in veterans with type 2 diabetes. N Engl J Med. 2009 Jan 8;360(2):129-39. doi: 10.1056/NEJMoa0808431. Epub 2008 Dec 17. Erratum in: N Engl J Med. 2009 Sep 3;361(10):1028. N Engl J Med. 2009 Sep 3;361(10):1024-5.

Emanuele N, Moritz T, Klein R, Davis MD, Glander K, Khanna A, Thottapurathu L, Bahn G, Duckworth W, Abraira C; Veterans Affairs Diabetes Trial Study Group. Ethnicity, race, and clinically significant macular edema in the Veterans Affairs Diabetes Trial (VADT). Diabetes Res Clin Pract. 2009 Nov;86(2):104-10. doi: 10.1016/j.diabres.2009.08.001. Epub 2009 Aug 31.

Kirkman MS, McCarren M, Shah J, Duckworth W, Abraira C; VADT Study Group. The association between metabolic control and prevalent macrovascular disease in Type 2 diabetes: the VA Cooperative Study in diabetes. J Diabetes Complications. 2006 Mar-Apr;20(2):75-80.

Abraira C, Duckworth W, McCarren M, Emanuele N, Arca D, Reda D, Henderson W. Design of the cooperative study on glycemic control and complications in diabetes mellitus type 2: Veterans Affairs Diabetes Trial. J Diabetes Complications. 2003 Nov-Dec;17(6):314-22.

More Information 

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT00032487
CSP #465-F: VA Diabetes Trial Follow-Up Study (VADT-FS)



  

Data Sharing Statement
CSP #465-F

What's available

Pending

Available Documentation 

Pending

Dates Data are Available 

Pending

Access Criteria

Pending

Study Characteristics
CSP #465-F

Objectives

  • To determine the long-term effects of intensive glycemic control in type 2 diabetes on major cardiovascular complications
  • To determine the long-term effects of intensive glycemic control in type 2 diabetes on four secondary outcomes:
    • cardiovascular mortality
    • major microvascular complications
    • health-related quality of life
    • total mortality

Era of Service

All

Population

Patients who participated in CSP #465

Study Design 

Prospective cohort study

Time Period 

February 2008 - May 2017

Setting

National

1,044

Response Rate

  • 2009: 83.6%
  • 2010: 81.2%
  • 2011: 82.7%

Recruitment Method

All active VADT study participants were approached by the site coordinators

Compensation

$10 gift card

Data Collected

  • Demographics
  • Self-reported health status
  • Occurrence of study primary endpoints: acute myocardial infarction, death from cardiovascular disease, stroke, congestive, heart failure, amputation from peripheral vascular disease (PVD), surgical intervention for coronary or PVD, and critical limb ischemia
  • VA or non-VA outpatient visits, hospitalizations and procedures

Data Collection Method

Standardized self-administered survey questionnaires (for health status, occurrence of study endpoints, VA or non-VA outpatient visits, hospitalizations, and procedures) 

Funding Source

VA Cooperative Studies Program (CSP)

Contact 

Gideon.Bahn@va.gov

Selected Publications 

Azad N, Agrawal L, Emanuele NV, Klein R, Bahn GD, McCarren M, Reaven P, Hayward R, Duckworth W; VADT Study Group. Association of PAI-1 and fibrinogen with diabetic retinopathy in the Veterans Affairs Diabetes Trial (VADT). Diabetes Care. 2014 Feb;37(2):501-6.

Anderson RJ, Bahn GD, Emanuele NV, Marks JB, Duckworth WC; VADT Study Group. Blood pressure and pulse pressure effects on renal outcomes in the Veterans Affairs Diabetes Trial (VADT). Diabetes Care. 2014 Oct;37(10):2782-8. doi: 10.2337/dc14-0284. Epub 2014 Jul 21.

Saremi A, Schwenke DC, Bahn G, Ge L, Emanuele N, Reaven PD; VADT Investigators. The effect of intensive glucose lowering therapy among major racial/ethnic groups in the Veterans Affairs Diabetes Trial. Metabolism. 2015 Feb;64(2):218-25. 

Hayward RA, Reaven PD, Emanuele NV; VADT Investigators. Follow-up of Glycemic Control and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015 Sep 3;373(10):978.  

More Information 

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT00756613