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→Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes
More than 25% of the patients admitted in the general wards have a history of diabetes mellitus. Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In veterans, the prevalence is disproportionally higher. It is estimated that 40% to 50% of hospitalized veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System, with which glucose values can be wirelessly transmitted from the patient’s bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.
ID: NCT03508934
Sponsor; Investigator: VA Office of Research and Development; Ilias Spanakis, MD
Locations: Baltimore VA Medical Center, Maryland
→Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation (GEM)
The population of older veterans with nontraumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for veterans with nontraumatic lower limb amputation. Additionally, this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for veterans with nontraumatic amputation through gait training programs based in motor learning principles, resulting in improved.
ID: NCT003995238
Sponsor; Investigator: VA Office of Research and Development; Cory L. Christiansen, PhD
Locations: Rocky Mountain Regional VA Medical Center, Aurora, Colorado; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia
→Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial (ACTIVet-2)
Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators haveshown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a hybrid type 2 effectiveness implementation trial using a cluster randomized stepped wedgedesign at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.
ID: NCT05169359
Sponsor; Investigator: VA Office of Research and Development; Howard S. Gordon, MD
Location: 8 locations, including Jesse Brown VA Medical Center, Chicago; Edward Hines Jr. VA Hopsital, Hines, Illinois
→The Diabetes Staging System in Patient Aligned Care Teams
The purpose of this study is to examine the feasibility/acceptability of the Diabetes Staging System in patient aligned care teams and its ability to increase sodium-glucosecotransporter-2 inhibitor and glucagon-like-1 peptide use in veteran patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease. A novel type 2 diabetes staging system patterned after Tumor Node Metastasis cancer staging that uses the number of macrovascular and microvascular complications and most recent hemoglobin A1c and glomerular filtration rate to determine Diabetes Staging System stage which reflects disease severity.
ID: NCT06142006
Sponsor; Collaborator: Durham VA Medical Center; Moahad Dar, MD
Location: Greenville VA Health Care Center, North Carolina
→Enhancing Mental and Physical Health of Women Veterans (EMPOWER)
Women veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women veterans’ needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation effectiveness trial testing 2 strategies designed to support implementation and sustainment of evidence-based practices for women veterans in at least 20 VA facilities from 4 regions.
ID: NCT05050266
Sponsor; Investigator: VA Office of Research and Development; Alison B. Hamilton, PhD, MPH
Location: VA Greater Los Angeles Healthcare System
→Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID)
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in patients with diabetes. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.
ID: NCT03012529
Sponsor; Investigator: VA Office of Research and Development; Paul A. Monach, MD, PhD
Location: 30 VA locations, including South Texas Health Care System, San Antonio; Cincinnati VA Medical Center, Ohio; VA Northern California Health Care System, Mather; Washington DC VA Medical Center; William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
→Effectiveness of Remote Foot Temperature Monitoring (STOP)
Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poorbecause the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a “smart” mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.
ID: NCT05728411
Sponsor; Investigator: VA Office of Research and Development; Rachel M. Thomas
Location: Edward Hines Jr. VA Hospital, Hines, Illinois; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia; VA Puget Sound Health Care System, Seattle, Washington
→Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit who received continuous glucose monitoring vs point of care glucose monitoring. The study will examine relevant outcomes for patients in the intensive care unit with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).
ID: NCT05442853
Sponsor; Investigator: Malcom Randall VA Medical Center; Andrew J. Franck, PharmD
Location: Malcolm Randall VA Medical Center, Gainesville, Florida
→Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)
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 veterans with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA 1c , 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 m 2 ; and do not fulfill any exclusion criteria.
ID: NCT04838392
Sponsor; Investigator: VA Office of Research and Development; Gregory G. Schwartz, PhD, MD
Locations: 40 locations
Actively Recruiting
→Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes
More than 25% of the patients admitted in the general wards have a history of diabetes mellitus. Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In veterans, the prevalence is disproportionally higher. It is estimated that 40% to 50% of hospitalized veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System, with which glucose values can be wirelessly transmitted from the patient’s bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.
ID: NCT03508934
Sponsor; Investigator: VA Office of Research and Development; Ilias Spanakis, MD
Locations: Baltimore VA Medical Center, Maryland
→Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation (GEM)
The population of older veterans with nontraumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for veterans with nontraumatic lower limb amputation. Additionally, this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for veterans with nontraumatic amputation through gait training programs based in motor learning principles, resulting in improved.
ID: NCT003995238
Sponsor; Investigator: VA Office of Research and Development; Cory L. Christiansen, PhD
Locations: Rocky Mountain Regional VA Medical Center, Aurora, Colorado; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia
→Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial (ACTIVet-2)
Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators haveshown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a hybrid type 2 effectiveness implementation trial using a cluster randomized stepped wedgedesign at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.
ID: NCT05169359
Sponsor; Investigator: VA Office of Research and Development; Howard S. Gordon, MD
Location: 8 locations, including Jesse Brown VA Medical Center, Chicago; Edward Hines Jr. VA Hopsital, Hines, Illinois
→The Diabetes Staging System in Patient Aligned Care Teams
The purpose of this study is to examine the feasibility/acceptability of the Diabetes Staging System in patient aligned care teams and its ability to increase sodium-glucosecotransporter-2 inhibitor and glucagon-like-1 peptide use in veteran patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease. A novel type 2 diabetes staging system patterned after Tumor Node Metastasis cancer staging that uses the number of macrovascular and microvascular complications and most recent hemoglobin A1c and glomerular filtration rate to determine Diabetes Staging System stage which reflects disease severity.
ID: NCT06142006
Sponsor; Collaborator: Durham VA Medical Center; Moahad Dar, MD
Location: Greenville VA Health Care Center, North Carolina
→Enhancing Mental and Physical Health of Women Veterans (EMPOWER)
Women veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women veterans’ needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation effectiveness trial testing 2 strategies designed to support implementation and sustainment of evidence-based practices for women veterans in at least 20 VA facilities from 4 regions.
ID: NCT05050266
Sponsor; Investigator: VA Office of Research and Development; Alison B. Hamilton, PhD, MPH
Location: VA Greater Los Angeles Healthcare System
→Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID)
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in patients with diabetes. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.
ID: NCT03012529
Sponsor; Investigator: VA Office of Research and Development; Paul A. Monach, MD, PhD
Location: 30 VA locations, including South Texas Health Care System, San Antonio; Cincinnati VA Medical Center, Ohio; VA Northern California Health Care System, Mather; Washington DC VA Medical Center; William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
→Effectiveness of Remote Foot Temperature Monitoring (STOP)
Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poorbecause the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a “smart” mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.
ID: NCT05728411
Sponsor; Investigator: VA Office of Research and Development; Rachel M. Thomas
Location: Edward Hines Jr. VA Hospital, Hines, Illinois; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia; VA Puget Sound Health Care System, Seattle, Washington
→Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit who received continuous glucose monitoring vs point of care glucose monitoring. The study will examine relevant outcomes for patients in the intensive care unit with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).
ID: NCT05442853
Sponsor; Investigator: Malcom Randall VA Medical Center; Andrew J. Franck, PharmD
Location: Malcolm Randall VA Medical Center, Gainesville, Florida
→Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)
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 veterans with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA 1c , 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 m 2 ; and do not fulfill any exclusion criteria.
ID: NCT04838392
Sponsor; Investigator: VA Office of Research and Development; Gregory G. Schwartz, PhD, MD
Locations: 40 locations
Actively Recruiting
→Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes
More than 25% of the patients admitted in the general wards have a history of diabetes mellitus. Up to 30% of the hospitalized diabetics develop hypoglycemia (low glucose values); a condition that is associated with seizures, cardiac arrhythmias, and even death. In veterans, the prevalence is disproportionally higher. It is estimated that 40% to 50% of hospitalized veterans are diabetics. In this clinical trial the investigators describe the development of a novel system, the Glucose Telemetry System, with which glucose values can be wirelessly transmitted from the patient’s bedside to a monitor device at the nursing station. The goal of this work is to develop a more effective glucose surveillance system at the general wards, which can decrease hypoglycemia in the hospital and improve clinical outcomes.
ID: NCT03508934
Sponsor; Investigator: VA Office of Research and Development; Ilias Spanakis, MD
Locations: Baltimore VA Medical Center, Maryland
→Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation (GEM)
The population of older veterans with nontraumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for veterans with nontraumatic lower limb amputation. Additionally, this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for veterans with nontraumatic amputation through gait training programs based in motor learning principles, resulting in improved.
ID: NCT003995238
Sponsor; Investigator: VA Office of Research and Development; Cory L. Christiansen, PhD
Locations: Rocky Mountain Regional VA Medical Center, Aurora, Colorado; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia
→Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial (ACTIVet-2)
Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators haveshown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a hybrid type 2 effectiveness implementation trial using a cluster randomized stepped wedgedesign at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.
ID: NCT05169359
Sponsor; Investigator: VA Office of Research and Development; Howard S. Gordon, MD
Location: 8 locations, including Jesse Brown VA Medical Center, Chicago; Edward Hines Jr. VA Hopsital, Hines, Illinois
→The Diabetes Staging System in Patient Aligned Care Teams
The purpose of this study is to examine the feasibility/acceptability of the Diabetes Staging System in patient aligned care teams and its ability to increase sodium-glucosecotransporter-2 inhibitor and glucagon-like-1 peptide use in veteran patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease. A novel type 2 diabetes staging system patterned after Tumor Node Metastasis cancer staging that uses the number of macrovascular and microvascular complications and most recent hemoglobin A1c and glomerular filtration rate to determine Diabetes Staging System stage which reflects disease severity.
ID: NCT06142006
Sponsor; Collaborator: Durham VA Medical Center; Moahad Dar, MD
Location: Greenville VA Health Care Center, North Carolina
→Enhancing Mental and Physical Health of Women Veterans (EMPOWER)
Women veterans are the fastest growing segment of VA users. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women veterans’ needs, and that they will want and be able to use those services. The EMPOWER QUERI 2.0 Program is a cluster randomized type 3 hybrid implementation effectiveness trial testing 2 strategies designed to support implementation and sustainment of evidence-based practices for women veterans in at least 20 VA facilities from 4 regions.
ID: NCT05050266
Sponsor; Investigator: VA Office of Research and Development; Alison B. Hamilton, PhD, MPH
Location: VA Greater Los Angeles Healthcare System
→Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics (VA INTREPID)
The purpose of this research study is to determine if rifampin, an antibiotic (a medicine that treats infections), is effective in treating osteomyelitis (infection of the bone) of the foot in patients with diabetes. Despite use of powerful antibiotics prescribed over a long period of time, many diabetic patients remain at a high risk for needing an amputation of part of the foot or lower leg because the osteomyelitis is not cured. Some small research studies have shown that addition of rifampin to other antibiotics is effective in treating osteomyelitis. However, because few diabetics with osteomyelitis have been studied, there is no definite proof that it is better than the usual treatments for diabetic patients. If this study finds that adding rifampin to the usual antibiotics prescribed for osteomyelitis reduces the risk for amputations, doctors will be able to more effectively treat many veteran patients with this serious infection. Improving treatment outcomes is an important healthcare goal of the VA.
ID: NCT03012529
Sponsor; Investigator: VA Office of Research and Development; Paul A. Monach, MD, PhD
Location: 30 VA locations, including South Texas Health Care System, San Antonio; Cincinnati VA Medical Center, Ohio; VA Northern California Health Care System, Mather; Washington DC VA Medical Center; William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin
→Effectiveness of Remote Foot Temperature Monitoring (STOP)
Diabetic foot ulcers are common, debilitating, and costly complications of diabetes, disproportionately impacting Black and rural veterans. Forty percent of individuals have an ulcer recurrence within a year of ulcer healing and 65% within 5 years. Monitoring plantar foot temperatures is one of the few interventions that reduces the risk of ulcer recurrence. Despite the evidence, adoption has been poorbecause the original procedures, including the use of handheld thermometers, were burdensome and time-consuming. Podimetrics, a private company, has developed a temperature monitoring system involving a “smart” mat that can wirelessly transmit data and a remote monitoring team that works with VA providers to assist with triage and monitoring. This care model has incredible promise, but has been untested in VA. The investigators propose to conduct a randomized trial to evaluate effectiveness of remote temperature monitoring as well as costs. Additionally, the investigators will evaluate the implementation process, including barriers and facilitators to use among key stakeholders.
ID: NCT05728411
Sponsor; Investigator: VA Office of Research and Development; Rachel M. Thomas
Location: Edward Hines Jr. VA Hospital, Hines, Illinois; Hunter Holmes McGuire VA Medical Center, Richmond, Virginia; VA Puget Sound Health Care System, Seattle, Washington
→Continuous Glucose Monitoring for Hyperglycemia in Critically Ill Patients
The investigators intend to conduct a single-center, prospective, randomized comparative trial of patients admitted to the intensive care unit who received continuous glucose monitoring vs point of care glucose monitoring. The study will examine relevant outcomes for patients in the intensive care unit with diabetes mellitus and/or hyperglycemia. The primary outcome of the study will be the proportion of time in target range (blood glucose 70-180 mg/dL).
ID: NCT05442853
Sponsor; Investigator: Malcom Randall VA Medical Center; Andrew J. Franck, PharmD
Location: Malcolm Randall VA Medical Center, Gainesville, Florida
→Investigation of Metformin in Pre-Diabetes on Atherosclerotic Cardiovascular OuTcomes (VA-IMPACT)
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 veterans with pre-diabetes and established atherosclerotic cardiovascular disease. Qualifying patients have pre-diabetes defined by HbA 1c , 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 m 2 ; and do not fulfill any exclusion criteria.
ID: NCT04838392
Sponsor; Investigator: VA Office of Research and Development; Gregory G. Schwartz, PhD, MD
Locations: 40 locations