RECRUITING

Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes

Conditions

Prediabetic State Atherosclerosis Metformin Hemoglobin A, Glycosylated Coronary Artery Disease Peripheral Arterial Disease Cerebrovascular Disorders

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research will help us to learn if the medicine called metformin reduces the risk of death, heart attacks, and/or strokes in Veterans who have pre-diabetes and heart or blood vessel problems.

Official Title

CSP #2002 - Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)

Quick Facts

Study Start:2023-04-03

Study Completion:2029-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02915198

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 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. 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). 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.	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

Inclusion Criteria

Exclusion 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.
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.
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).
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.

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

Contacts and Locations

Study Contact

Gregory G Schwartz, PhD MD

CONTACT

(720) 723-6070

Gregory.Schwartz@va.gov

Principal Investigator

Gregory G. Schwartz, PhD MD

STUDY_CHAIR

Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Locations (Sites)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012

United States

Southern Arizona VA Health Care System, Tucson, AZ

Tucson, Arizona, 85723-0001

United States

Central Arkansas VHS John L. McClellan Memorial Veterans Hospital, Little Rock, AR

Little Rock, Arkansas, 72205-5484

United States

VA Loma Linda Healthcare System, Loma Linda, CA

Loma Linda, California, 92357-1000

United States

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822

United States

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207

United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002

United States

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003

United States

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045

United States

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770

United States

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, 33744-0000

United States

North Florida/South Georgia Veterans Health System, Gainesville, FL

Gainesville, Florida, 32608-1135

United States

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125

United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004

United States

VA Pacific Islands Health Care System, Honolulu, HI

Honolulu, Hawaii, 96819-1522

United States

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612

United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030

United States

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2292

United States

Lexington VA Medical Center, Lexington, KY

Lexington, Kentucky, 40502-2235

United States

Rehabilitation R&D Service, Baltimore, MD

Baltimore, Maryland, 21202

United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817

United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309

United States

Kansas City VA Medical Center, Kansas City, MO

Kansas City, Missouri, 64128-2226

United States

Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE

Omaha, Nebraska, 68105-1850

United States

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153

United States

Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

New York, New York, 10010-5011

United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875

United States

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220-2213

United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702

United States

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964

United States

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703

United States

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Columbia, South Carolina, 29209-1638

United States

Memphis VA Medical Center, Memphis, TN

Memphis, Tennessee, 38104-2127

United States

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216-7167

United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211

United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001

United States

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249

United States

Salem VA Medical Center, Salem, VA

Salem, Virginia, 24153-6404

United States

Huntington VA Medical Center, Huntington, WV

Huntington, West Virginia, 25704-9300

United States

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-0001

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Gregory G. Schwartz, PhD MD, STUDY_CHAIR, Rocky Mountain Regional VA Medical Center, Aurora, CO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-03

Study Completion Date2029-03-31

Study Record Updates

Study Start Date2023-04-03

Study Completion Date2029-03-31

Terms related to this study

Keywords Provided by Researchers

Metformin
Atherosclerosis
Prediabetic State
Hemoglobin A, Glycosylated
Coronary Artery Disease
Peripheral Arterial Disease
Cerebrovascular Disorders

Additional Relevant MeSH Terms

Prediabetic State
Atherosclerosis
Metformin