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Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)

Primary Purpose

Prediabetic State, Atherosclerosis, Metformin

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metformin XR
Placebo
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prediabetic State focused on measuring Metformin, Atherosclerosis, Prediabetic State, Hemoglobin A, Glycosylated, Coronary Artery Disease, Peripheral Arterial Disease, Cerebrovascular Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg/dL; or a 2-hour plasma glucose level of 140-199 mg/dL following a 75 g glucose load oral glucose tolerance test.
  2. Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation.

Coronary artery disease is fulfilled by at least one of (1), (2), or (3):

  1. History of myocardial infarction at least one month prior to randomization.
  2. History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization.
  3. Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries.

Cerebrovascular disease is fulfilled by at least one of criteria (1) through (4):

  1. Documented prior ischemic stroke (at least one month prior to randomization),
  2. Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s),
  3. Asymptomatic carotid stenosis of at least 70% luminal diameter,
  4. History of carotid revascularization (surgical or catheter-based).

Peripheral arterial disease: Fulfilled by at least one of the following:

  1. History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia,
  2. Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85.

3. Renal function: Estimated glomerular filtration rate at least 45 mL/min/1.73 m2.

4. Informed consent has been fully executed, and participant agrees to study procedures.

Exclusion Criteria:

  1. Treatment with metformin or other anti-diabetic medication within 12 months of randomization. Note: In the absence of a diagnosis of diabetes, inpatient treatment with insulin or treatment with an SGLT2 inhibitor (e.g., for heart failure) or a GLP-1 receptor agonist (e.g., for obesity) is not exclusionary.
  2. Treatment with systemic glucocorticoids within 3 months of randomization
  3. Fasting plasma glucose 140 mg/dL measured between screening and randomization visits, or any plasma glucose 200 mg/dL or HbA1c 7.0% measured within 12 months of randomization.
  4. Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel
  5. Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor.
  6. Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin > 2 times upper limit of normal
  7. Binge or heavy alcohol consumption within 6 months of randomization
  8. Severe anemia (hemoglobin < 10 g/dL)
  9. Prior history of intolerance to metformin
  10. Myocardial infarction, coronary revascularization procedure, or stroke within 1 month of randomization
  11. Uncontrolled hypertension at screening assessment (systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg
  12. Acute or decompensated congestive heart failure
  13. Expected survival less than study duration
  14. Participants considered to be unable, unwilling, or unreliable to meet protocol requirements
  15. Impaired decision-making capacity, defined by any history of dementia or cognitive impairment
  16. Concurrent participation in another research study involving a randomized comparison of drug or device treatments, unless specifically excepted.
  17. Pregnant, intent to become pregnant during the trial, or lactating
  18. Women of childbearing potential who are not using a highly effective method of contraception

Sites / Locations

  • Phoenix VA Health Care System, Phoenix, AZRecruiting
  • Southern Arizona VA Health Care System, Tucson, AZRecruiting
  • Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, ARRecruiting
  • VA Loma Linda Healthcare System, Loma Linda, CARecruiting
  • VA Long Beach Healthcare System, Long Beach, CARecruiting
  • VA Palo Alto Health Care System, Palo Alto, CARecruiting
  • VA San Diego Healthcare System, San Diego, CARecruiting
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CARecruiting
  • Rocky Mountain Regional VA Medical Center, Aurora, CORecruiting
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT
  • Bay Pines VA Healthcare System, Pay Pines, FL
  • North Florida/South Georgia Veterans Health System, Gainesville, FLRecruiting
  • Miami VA Healthcare System, Miami, FLRecruiting
  • Atlanta VA Medical and Rehab Center, Decatur, GARecruiting
  • VA Pacific Islands Health Care System, Honolulu, HIRecruiting
  • Jesse Brown VA Medical Center, Chicago, IL
  • Edward Hines Jr. VA Hospital, Hines, ILRecruiting
  • Iowa City VA Health Care System, Iowa City, IARecruiting
  • Lexington VA Medical Center, Lexington, KY
  • Rehabilitation R&D Service, Baltimore, MDRecruiting
  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MARecruiting
  • Minneapolis VA Health Care System, Minneapolis, MNRecruiting
  • Kansas City VA Medical Center, Kansas City, MORecruiting
  • Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NERecruiting
  • New Mexico VA Health Care System, Albuquerque, NMRecruiting
  • Manhattan Campus of the VA NY Harbor Healthcare System, New York, NYRecruiting
  • Durham VA Medical Center, Durham, NCRecruiting
  • Cincinnati VA Medical Center, Cincinnati, OHRecruiting
  • Louis Stokes VA Medical Center, Cleveland, OHRecruiting
  • VA Portland Health Care System, Portland, ORRecruiting
  • Ralph H. Johnson VA Medical Center, Charleston, SC
  • Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SCRecruiting
  • Memphis VA Medical Center, Memphis, TNRecruiting
  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXRecruiting
  • Michael E. DeBakey VA Medical Center, Houston, TXRecruiting
  • VA Salt Lake City Health Care System, Salt Lake City, UTRecruiting
  • Hunter Holmes McGuire VA Medical Center, Richmond, VARecruiting
  • Salem VA Medical Center, Salem, VARecruiting
  • Huntington VA Medical Center, Huntington, WVRecruiting
  • Clement J. Zablocki VA Medical Center, Milwaukee, WIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metformin

Placebo

Arm Description

Participants receive initial treatment with metformin XR 500 mg 1 tablet daily, with stepwise titration to a maximum dose of 2000 mg (4 tablets) daily.

Participants receive initial treatment with 1 tablet daily of placebo (for metformin XR), with stepwise titration to a maximum of 4 tablets daily.

Outcomes

Primary Outcome Measures

Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization
The primary outcome measure is the time to first occurrence of death, non-fatal myocardial infarction or stroke, hospitalization for unstable angina with objective evidence of acute myocardial ischemia, or coronary revascularization driven by acute or progressive symptoms.

Secondary Outcome Measures

Time in days to Cardiovascular Outcomes
Time to first occurrence of death, myocardial infarction, or stroke Time to first occurrence of a primary endpoint event, peripheral arterial disease event, or hospitalization for congestive heart failure Cumulative incidence of all components of the primary endpoint, including recurrent or multiple events in the same participant Cumulative incidence and time to first occurrence of each component of the primary outcome measure, peripheral arterial disease events, and hospitalization for congestive heart failure
Time in days to Oncologic Outcome
Time to new or recurrent diagnosis of a malignancy or death from a malignancy
Time in days to Diabetes Outcome
Time to new diagnosis of type 2 diabetes

Full Information

First Posted
September 13, 2016
Last Updated
September 27, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02915198
Brief Title
Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes
Acronym
VA-IMPACT
Official Title
CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2023 (Actual)
Primary Completion Date
March 31, 2029 (Anticipated)
Study Completion Date
March 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in patients who have pre-diabetes and heart or blood vessel problems.
Detailed Description
CSP #2002 is a multicenter, prospective, randomized, double blind, secondary prevention trial to test the hypothesis that treatment with metformin, compared with placebo, reduces mortality and cardiovascular morbidity in patients with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA1c, fasting blood glucose, or oral glucose tolerance test criteria; clinically evident coronary, cerebrovascular, or peripheral arterial atherosclerotic cardiovascular disease; and estimated glomerular filtration rate of at least 45 mL/min/1.73 m2; and do not fulfill any exclusion criteria. Patients who are eligible and agree to participate are randomly assigned to treatment with metformin XR (titrated to a maximum dose of 2000 mg daily based on safety and tolerability) or matching placebo. All patients receive counseling on therapeutic lifestyle recommendations. CSP #2002 had a Pilot Phase trial from 2/2019 to 1/2021 and was approved for the full-scale trial, with projected full-scale launch in 10/2022.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State, Atherosclerosis, Metformin
Keywords
Metformin, Atherosclerosis, Prediabetic State, Hemoglobin A, Glycosylated, Coronary Artery Disease, Peripheral Arterial Disease, Cerebrovascular Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Arm Description
Participants receive initial treatment with metformin XR 500 mg 1 tablet daily, with stepwise titration to a maximum dose of 2000 mg (4 tablets) daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive initial treatment with 1 tablet daily of placebo (for metformin XR), with stepwise titration to a maximum of 4 tablets daily.
Intervention Type
Drug
Intervention Name(s)
Metformin XR
Intervention Description
The study medication dose may be increased by a step-wise fashion up to a maximum of 4 tablets per day.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
For patients < 80 years of age at the time of a study visit, and with most recent eGFR 45 mL/min/1.73 m2, study medication dose may be increased in a stepwise fashion to a maximum of 4 tablets daily, corresponding to metformin XR 2000 mg or matching placebo. For patients 80 years of age or with most recent 30 eGFR < 45 mL/min/1.73 m2, the maximum dose of study medication is 2 tablets daily, corresponding to metformin XR 1000 mg or matching placebo
Primary Outcome Measure Information:
Title
Time in days to death, non-fatal myocardial infarction, stroke, hospitalization for unstable angina, or symptom-driven coronary revascularization
Description
The primary outcome measure is the time to first occurrence of death, non-fatal myocardial infarction or stroke, hospitalization for unstable angina with objective evidence of acute myocardial ischemia, or coronary revascularization driven by acute or progressive symptoms.
Time Frame
through study completion, an average of 4.5 years
Secondary Outcome Measure Information:
Title
Time in days to Cardiovascular Outcomes
Description
Time to first occurrence of death, myocardial infarction, or stroke Time to first occurrence of a primary endpoint event, peripheral arterial disease event, or hospitalization for congestive heart failure Cumulative incidence of all components of the primary endpoint, including recurrent or multiple events in the same participant Cumulative incidence and time to first occurrence of each component of the primary outcome measure, peripheral arterial disease events, and hospitalization for congestive heart failure
Time Frame
through study completion, an average of 4.5 years
Title
Time in days to Oncologic Outcome
Description
Time to new or recurrent diagnosis of a malignancy or death from a malignancy
Time Frame
through study completion, an average of 4.5 years
Title
Time in days to Diabetes Outcome
Description
Time to new diagnosis of type 2 diabetes
Time Frame
through study completion, an average of 4.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-diabetes: This condition is fulfilled by HbA1c of at least 5.7%, but less than 6.5%; or two measurements of fasting plasma glucose (on separate days) of 100-125 mg/dL; or a 2-hour plasma glucose level of 140-199 mg/dL following a 75 g glucose load oral glucose tolerance test. Established atherosclerotic cardiovascular disease: Qualifying participants must have evidence of atherosclerotic disease in at least one of the following vascular beds: coronary, cerebrovascular, or peripheral arterial circulation. Coronary artery disease is fulfilled by at least one of (1), (2), or (3): History of myocardial infarction at least one month prior to randomization. History of percutaneous coronary intervention or coronary artery bypass surgery at least one month prior to randomization. Angiographic evidence of coronary stenosis of at least 50% in at least two major epicardial coronary arteries. Cerebrovascular disease is fulfilled by at least one of criteria (1) through (4): Documented prior ischemic stroke (at least one month prior to randomization), Carotid artery stenosis 50% and history of transient ischemic attack or transient ischemic visual symptoms attributable to the identified lesion(s), Asymptomatic carotid stenosis of at least 70% luminal diameter, History of carotid revascularization (surgical or catheter-based). Peripheral arterial disease: Fulfilled by at least one of the following: History of aorto-iliac or peripheral artery intervention (surgical or catheter based) for limb ischemia, or amputation for limb ischemia, Symptoms of intermittent claudication with ankle:brachial index less than or equal to 0.85. 3. Renal function: Estimated glomerular filtration rate at least 45 mL/min/1.73 m2. 4. Informed consent has been fully executed, and participant agrees to study procedures. Exclusion Criteria: Treatment with metformin or other anti-diabetic medication within 12 months of randomization. Note: In the absence of a diagnosis of diabetes, inpatient treatment with insulin or treatment with an SGLT2 inhibitor (e.g., for heart failure) or a GLP-1 receptor agonist (e.g., for obesity) is not exclusionary. Treatment with systemic glucocorticoids within 3 months of randomization Fasting plasma glucose 140 mg/dL measured between screening and randomization visits, or any plasma glucose 200 mg/dL or HbA1c 7.0% measured within 12 months of randomization. Total CO2 below the local laboratory lower limit of normal on most recent blood chemistry panel Current treatment with cimetidine, vandetanib, or a systemic treatment with a carbonic anhydrase inhibitor. Cirrhosis, active hepatitis, or jaundice at time of randomization, or total bilirubin > 2 times upper limit of normal Binge or heavy alcohol consumption within 6 months of randomization Severe anemia (hemoglobin < 10 g/dL) Prior history of intolerance to metformin Myocardial infarction, coronary revascularization procedure, or stroke within 1 month of randomization Uncontrolled hypertension at screening assessment (systolic blood pressure 180 mm Hg or diastolic blood pressure 110 mm Hg Acute or decompensated congestive heart failure Expected survival less than study duration Participants considered to be unable, unwilling, or unreliable to meet protocol requirements Impaired decision-making capacity, defined by any history of dementia or cognitive impairment Concurrent participation in another research study involving a randomized comparison of drug or device treatments, unless specifically excepted. Pregnant, intent to become pregnant during the trial, or lactating Women of childbearing potential who are not using a highly effective method of contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gregory G Schwartz, PhD MD
Phone
(720) 723-6070
Email
Gregory.Schwartz@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory G. Schwartz, PhD MD
Organizational Affiliation
Rocky Mountain Regional VA Medical Center, Aurora, CO
Official's Role
Study Chair
Facility Information:
Facility Name
Phoenix VA Health Care System, Phoenix, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Reaven, MD
Phone
602-277-5551
Ext
6875
Email
Peter.Reaven@va.gov
Facility Name
Southern Arizona VA Health Care System, Tucson, AZ
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Punit Goel, MD
Phone
520-792-1450
Ext
16445
Email
Punit.Goel@va.gov
Facility Name
Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205-5484
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barry Uretsky, MD
Phone
501-257-5808
Email
Barry.Uretsky@va.gov
Facility Name
VA Loma Linda Healthcare System, Loma Linda, CA
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357-1000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geir Frivold, MD
Phone
909-825-7084
Ext
3629
Email
Geir.frivold@va.gov
Facility Name
VA Long Beach Healthcare System, Long Beach, CA
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Vo, MD
Phone
562-826-3497
Email
Anthony.Vo@va.gov
Facility Name
VA Palo Alto Health Care System, Palo Alto, CA
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-1207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arlina Ahluwalia, MD
Phone
650-493-5000
Ext
61755
Email
Arlina.Ahluwalia@va.gov
First Name & Middle Initial & Last Name & Degree
Paul Heidenreich, MD
Phone
6504935000
Ext
64069
Email
Paul.Heidenreich@va.gov
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leda Felicio, MD
Phone
858-552-8585
Ext
2232
Email
leda.felicio@va.gov
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073-1003
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tannaz Moin, MD
Phone
310-478-3711
Ext
48380
Email
Tannaz.Moin@va.gov; tmoin@mednet.ucla.edu
Facility Name
Rocky Mountain Regional VA Medical Center, Aurora, CO
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sridharan Raghavan, MD PhD
Phone
415-254-3563
Email
Sridharan.Raghavan@va.gov
First Name & Middle Initial & Last Name & Degree
Gregory G. Schwartz, PhD MD
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516-2770
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Malm, MD
Phone
203-932-5711
Ext
2650
Email
Brian.Malm@va.gov
Facility Name
Bay Pines VA Healthcare System, Pay Pines, FL
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744-0000
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manjunath Harlapur, MD
Phone
727-398-6661
Ext
14893
Email
Manjunath.Harlapur@va.gov
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608-1135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carsten Schmalfuss, MD
Phone
352-376-1611
Ext
6052
Email
Carsten.Schmalfuss@va.gov
Facility Name
Miami VA Healthcare System, Miami, FL
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Palacio, MD
Phone
305-926-3780
Email
Ana.Palacio@va.gov
Facility Name
Atlanta VA Medical and Rehab Center, Decatur, GA
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033-4004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Rhee, MD
Phone
404-321-6111
Ext
202080
Email
Mary.Rhee@va.gov
Facility Name
VA Pacific Islands Health Care System, Honolulu, HI
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819-1522
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Shikuma-Lee, MD
Phone
808-433-7643
Email
Kelsey.ShikumaLee@va.gov
Facility Name
Jesse Brown VA Medical Center, Chicago, IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Terminated
Facility Name
Edward Hines Jr. VA Hospital, Hines, IL
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141-3030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Dayal, MD
Phone
708-202-8387
Ext
24564
Email
Amit.Dayal@va.gov
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2292
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Katz, MD
Phone
319-353-8622
Email
David.Katz2@va.gov
Facility Name
Lexington VA Medical Center, Lexington, KY
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502-2235
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Karounos, MD
Phone
859-233-4511
Ext
4430
Email
Dennis.Karounos@va.gov
Facility Name
Rehabilitation R&D Service, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilias Spanakis, MD
Phone
410-605-7000
Ext
7394
Email
Ilias.Spanakis@va.gov
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Scott Kinlay, MD
Phone
857-203-6840
Email
Scott.Kinlay@va.gov
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417-2309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Selcuk Adabag, MD
Phone
612-467-3655
Email
Selcuk.Adabag@va.gov
Facility Name
Kansas City VA Medical Center, Kansas City, MO
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128-2226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Garcia-Touza, MD
Phone
914-886-3866
Email
Mariana.Garcia-Touza@va.gov
Facility Name
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105-1850
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrus Desouza, MD
Phone
402-346-8800
Ext
5506
Email
cyrus.desouza@va.gov
Facility Name
New Mexico VA Health Care System, Albuquerque, NM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle D Ratliff, MD
Phone
505-265-1711
Ext
4495
Email
Michelle.Ratliff@va.gov
Facility Name
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
City
New York
State/Province
New York
ZIP/Postal Code
10010-5011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binita Shah, MD
Phone
212-686-7500
Ext
7722
Email
Binita.Shah@va.gov
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705-3875
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Crowley, MD
Phone
919-599-8865
Email
Matthew.Crowley@va.gov
Facility Name
Cincinnati VA Medical Center, Cincinnati, OH
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220-2213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanan Kerr, MD
Phone
513-260-3565
Email
Hanan.Kerr@va.gov
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-1702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure Sayyed Kassem, MD
Phone
216-791-3800
Ext
65184
Email
Laure.SayyedKassem@va.gov
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207-2964
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
North Noelck, MD
Phone
503-220-8262
Ext
56426
Email
North.Noelck2@va.gov
First Name & Middle Initial & Last Name & Degree
Linda Humphrey, MD
Phone
5032208262
Ext
57176
Email
Linda.Humphrey@va.gov
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5703
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Waring, MD
Phone
843-789-6467
Email
Ashley.Waring@va.gov
Facility Name
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29209-1638
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Subhashini Yaturu, MD
Phone
803-776-4000
Ext
6092
Email
Subhashini.Yaturu@va.gov
Facility Name
Memphis VA Medical Center, Memphis, TN
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104-2127
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard D Childress, MD
Phone
901-523-8990
Ext
6817
Email
richard.childress@va.gov
Facility Name
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216-7167
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Sam, MD
Phone
214-857-1477
Email
Colleen.Sam@va.gov
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arunima Misra, MD
Phone
713-791-1414
Ext
27940
Email
Arunima.Misra@va.gov
Facility Name
VA Salt Lake City Health Care System, Salt Lake City, UT
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Lui, MD
Phone
801-582-1565
Email
Charles.Lui@va.gov
Facility Name
Hunter Holmes McGuire VA Medical Center, Richmond, VA
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward McFalls, MD
Phone
804-675-5419
Email
Edward.McFalls@va.gov
Facility Name
Salem VA Medical Center, Salem, VA
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153-6404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Iranmanesh, MD
Phone
540-983-1071
Email
Ali.Iranmanesh@va.gov
Facility Name
Huntington VA Medical Center, Huntington, WV
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25704-9300
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Sias, MD
Phone
304-429-6755
Ext
2580
Email
Tina.Sias@va.gov
Facility Name
Clement J. Zablocki VA Medical Center, Milwaukee, WI
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295-0001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Kay, MD
Phone
414-384-2000
Ext
42263
Email
Cynthia.Kay@va.gov

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

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