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VA » Health Care » VA Cooperative Studies Program (CSP) » Home Page » Epidemiology Centers (CSPECs) » INVESTD-R » CSP #465: VA Diabetes Trial (VADT) and CSP #465-F: VA Diabetes Trial Follow-up Study (VADT-FS)

VA Cooperative Studies Program (CSP)

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)

Investigator Access CSP #465
What's Available	Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.
Available Documentation
Dates Data are Available
Access Criteria	Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Gideon.Bahn@va.gov. Investigators may be asked to provide further documentation such as a study proposal. All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.
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
Interventions	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
N	1,791 participants
Response Rate	Unconfirmed
Recruitment Method	Twenty VA medical centers screened and recruited patients meeting the eligibility criteria. Those providing informed consent were enrolled in the study.
Compensation	Unconfirmed
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 and instruments administered during clinical visits
Funding Sources	VA Cooperative Studies Program (CSP) American Diabetes Association National Eye Institute GlaxoSmithKline (GSK) Novo Nordisk Roche Diagnostics Sanofi-Aventis Amylin Kos Pharmaceuticals
Investigators	Co-Investigator: Carlos Abraira, MD Co-Investigator: William Duckworth, MD
Contact	Study Contact: Gideon Bahn; 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) Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)

Investigator Access CSP #465-F
What's Available	Check with the study contact and publications for information on a public dataset, data archive, data enclave, or website where data might be available.
Available Documentation
Dates Data are Available
Access Criteria	Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Gideon.Bahn@va.gov. Investigators may be asked to provide further documentation such as a study proposal. All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.
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 VADT clinical trial
Study Design	Prospective cohort
Time Period	February 2008 - May 2017
Setting	National
N	1,044 participants
Response Rate	2009: 83.6% 2010: 81.2% 2011: 82.7%
Recruitment Method	All active VADT study participants were approached by the site coordinators for participation
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)
Investigators	Unconfirmed
Contact	Study Contact: Gideon Bahn; 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 Dimensions for VA summary (Requires an account to access outside the VA network. Dimensions for VA is a database that connects publications, grants, patents, clinical trials, and policy documents)

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