Actively Recruiting
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular Outcomes (VA-IMPACT)
Led by VA Office of Research and Development · Updated on 2025-12-17
7410
Participants Needed
40
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether the medicine metformin can reduce the risk of death, heart attacks, and strokes in Veterans who have pre-diabetes along with problems related to heart or blood vessels. This is a multicenter, prospective, randomized, double-blind trial focused on secondary prevention to compare metformin with placebo in reducing mortality and cardiovascular complications. Eligible participants have pre-diabetes based on blood sugar levels and established atherosclerotic cardiovascular disease, with adequate kidney function. Participants are randomly assigned to receive either metformin extended-release (XR) or a matching placebo. The treatment starts with 500 mg of metformin XR or placebo once daily, with doses gradually increased up to 2000 mg daily as tolerated. All participants also receive counseling on lifestyle changes to support their health. The study began its full-scale phase in April 2023 following a pilot phase and will continue with treatment and monitoring over several years. During the study, participants will have regular assessments including monitoring for death, heart attacks, strokes, hospitalizations for unstable angina, and coronary procedures, tracked over an average of 4.5 years. Researchers will measure time to these events as the main outcome. Secondary outcomes include cardiovascular, cancer-related, and diabetes-related events. Participants will be followed closely to ensure safety and adherence to the study medication and procedures throughout the trial period.
CONDITIONS
Brief Title
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with pre-diabetes based on HbA1c, fasting glucose, or oral glucose tolerance test
- Established atherosclerotic cardiovascular disease in coronary, cerebrovascular, or peripheral arteries
- Estimated glomerular filtration rate of at least 45 mL/min/1.73 m2
- Ability and willingness to provide informed consent and follow study procedures
You will not qualify if you...
- Use of metformin or other anti-diabetic medications within 12 months prior to randomization
- Treatment with systemic glucocorticoids within 3 months prior to randomization
- Fasting plasma glucose over 130 mg/dL or HbA1c 7.0% or higher within 12 months
- Low total CO2 below normal laboratory limits
- Current use of cimetidine, vandetanib, or systemic carbonic anhydrase inhibitors
- Liver problems such as cirrhosis, active hepatitis, or jaundice
- Heavy alcohol use within 6 months
- Severe anemia with hemoglobin less than 10 g/dL
- History of metformin intolerance
- Heart attack, coronary procedure, or stroke within 1 month prior to randomization
- Uncontrolled high blood pressure
- Acute or decompensated heart failure
- Expected survival less than study duration
- Inability or unwillingness to comply with study requirements
- Dementia or cognitive impairment
- Participation in other randomized drug or device trials
- Pregnancy, intent to become pregnant, or breastfeeding
- Women of childbearing potential not using highly effective contraception
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4.5 years
Participants receive metformin XR or placebo with dose titration up to a maximum of 2000 mg daily based on safety and tolerability, along with counseling on therapeutic lifestyle recommendations.
Regular visits for medication management and safety monitoring
Trial Site Locations
Total: 40 locations
1
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
Actively Recruiting
2
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States, 85723-0001
Actively Recruiting
3
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
Little Rock, Arkansas, United States, 72205-5484
Actively Recruiting
4
VA Loma Linda Healthcare System, Loma Linda, CA
Loma Linda, California, United States, 92357-1000
Actively Recruiting
5
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States, 90822
Actively Recruiting
6
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1207
Actively Recruiting
7
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
Actively Recruiting
8
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States, 90073-1003
Actively Recruiting
9
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States, 80045-7211
Actively Recruiting
10
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516-2770
Actively Recruiting
11
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States, 33744-0000
Actively Recruiting
12
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, United States, 32608-1135
Actively Recruiting
13
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
Actively Recruiting
14
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States, 30033-4004
Actively Recruiting
15
VA Pacific Islands Health Care System, Honolulu, HI
Honolulu, Hawaii, United States, 96819-1522
Actively Recruiting
16
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Terminated
17
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-3030
Actively Recruiting
18
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2292
Actively Recruiting
19
Lexington VA Medical Center, Lexington, KY
Lexington, Kentucky, United States, 40502-2235
Not Yet Recruiting
20
Rehabilitation R&D Service, Baltimore, MD
Baltimore, Maryland, United States, 21202
Actively Recruiting
21
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Actively Recruiting
22
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417-2309
Actively Recruiting
23
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States, 64128-2226
Actively Recruiting
24
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States, 68105-1850
Actively Recruiting
25
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States, 87108-5153
Actively Recruiting
26
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010-5011
Actively Recruiting
27
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705-3875
Actively Recruiting
28
Cincinnati VA Medical Center, Cincinnati, OH
Cincinnati, Ohio, United States, 45220-2213
Active, Not Recruiting
29
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702
Actively Recruiting
30
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97207-2964
Actively Recruiting
31
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5703
Actively Recruiting
32
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
Columbia, South Carolina, United States, 29209-1638
Actively Recruiting
33
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, United States, 38104-2127
Actively Recruiting
34
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216-7167
Actively Recruiting
35
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211
Actively Recruiting
36
VA Salt Lake City Health Care System, Salt Lake City, UT
Salt Lake City, Utah, United States, 84148-0001
Actively Recruiting
37
Hunter Holmes McGuire VA Medical Center, Richmond, VA
Richmond, Virginia, United States, 23249
Actively Recruiting
38
Salem VA Medical Center, Salem, VA
Salem, Virginia, United States, 24153-6404
Actively Recruiting
39
Huntington VA Medical Center, Huntington, WV
Huntington, West Virginia, United States, 25704-9300
Actively Recruiting
40
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, United States, 53295-0001
Actively Recruiting
Research Team
G
Gregory G Schwartz, PhD MD
K
Kevin Gropp
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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