Cardiovascular Kidney Metabolic SyndromeDASH-CKMHNCT07188545
Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
An observational study of Cardiovascular Kidney Metabolic Syndrome, run by Ohio State University at 1 site in United States.
Trial summary
Complex pathophysiological interactions among obesity, metabolic risk factors, chronic kidney disease (CKD), and the cardiovascular system lead to poor cardiovascular-kidney-metabolic health (CKMH), which is a major determinant of premature morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Kidney Metabolic Syndrome
- What is being tested?
- Intervention and Active Comparator
- Type of treatment
- Pill or oral medicine
- How many people
- 23,280,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 30 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The data for this study comes from claims and electronic health records data sources. MarketScan and All of Us are nationally representative databases, and therefore contain patients from all over the US. LifeScale is a local database from The Ohio State University Wexner Medical Center (OSUWMC) and contains patients who seek care at OSUWMC inpatient and outpatient facilities. Adult patients included in the study have evidence of CKMS stage 1 or 2, ≥1 prescription for a GLP-1RA, SGLT2i, DPP4i, or obesity medication, and at least 180 days of continuous database enrollment prior to the first prescription for any medication of interest. Patients will be excluded if they have evidence of stage 3 or 4 CKMS, cancer, renal replacement therapy, end stage renal disease, or solid organ transplant during the baseline period (180 days prior to index date), any history of type I diabetes, or missing sex information. These study criteria will be applied to each of the sources of secondary data to co
Who may be able to join
- Stage 1 or 2 CKMS at baseline
- At least one prescription for an intervention or comparator medication after CKMS diagnosis
- At least 180 days of continuous enrollment prior to the first prescription for any medication of interest (index date)
- Age 18+ at index date
Who cannot join
- Stage 3 or 4 CKMS at baseline
- Medications of interest during baseline period
- Any history of type I diabetes
- Cancer at baseline
- Renal replacement therapy at baseline
- End stage renal disease at baseline
- Solid organ transplant at baseline
- Missing sex
Trial locations and contacts
1 site in 1 country.
About this study
Complex pathophysiological interactions among obesity, metabolic risk factors, chronic kidney disease (CKD), and the cardiovascular system lead to poor cardiovascular-kidney-metabolic health (CKMH), which is a major determinant of premature morbidity and mortality. Poor CKMH may lead to cardiovascular-kidney-metabolic syndrome (CKMS) - the five-stage framework introduced by The American Heart Association (AHA) which accounts for the critical overlap between cardiorenal syndrome and cardiometabolic disease.
Evidence from randomized controlled trials shows glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter-2 inhibitors (SGLT2is) may improve CKMH in individuals with Type 2 Diabetes (T2D) and/ or obesity. However, there is modest evidence suggesting differential effectiveness of GLP-1RA and SGLT2i drugs between males and females. The extent of these sex-based differences is currently unknown. In part, this may be due to underrepresentation of females in clinical trials. Exploring sex-based differences in GLP-1RA and SGLT2i treatment on CKMH outcomes is important to inform CKMS treatment and equity in CKMH.
Robust secondary data sources present the opportunity to elucidate sex heterogeneity in GLP-1RA and SGLT2i treatment on CKMH outcomes. Using a target-trial emulation design, this study aims to observe differences in long-term CKMH outcomes between patients treated by GLP-1RA and SGLT2i medications versus those treated with active comparator medications, and whether there is an observed interaction between sex and treatment.
Read the detailed description
A target-trial design will be conducted in three sources of secondary data: 1)Merative Marketscan (claims-based data derived from commercial insurers), 2) All of Us (public database of Electronic Health Record [EHR] and survey data), and 3) LifeScale (EHR- derived from The Ohio State University Wexner Medical Center).
To construct a clinically similar comparator group, we opted for patients treated with active comparator medications with similar indications to the GLP-1RA and SGLT2i intervention medications. The intervention group is defined as patients with any exposure to the intervention medications, and the comparator group is defined as exposure to the comparator medications with no exposure to the intervention medications in the 30 days following index.
To balance baseline characteristics between intervention and comparator groups, for each cohort established in the three secondary data sources we will apply propensity score matching. Matching variables will include the following confounders: index age, U.S. region, race/ethnicity (where available), rurality, insurance type, Charlson comorbidity index score, index year, Medicaid expansion status in state of residence. Match quality will be assessed by examining standardized mean differences (SMDs) of matching variables by treatment and control, with SMD ≤ 10% indicating a well-balanced cohort after matching.
The primary outcome of interest is 3-P MACE (three-point major adverse cardiovascular event), defined as any of the following: nonfatal myocardial infarction, nonfatal stroke, or cardiac-related death. Secondary outcomes include: all-cause mortality, advancing CKMS stage, stroke, myocardial infarction, incident coronary heart disease diagnosis, incident peripheral artery disease diagnosis, atrial fibrillation diagnosis, renal failure, kidney transplant, and kidney dialysis.
Primary and secondary outcomes are time-to-event variables; thus, differences in risk of outcomes between intervention and comparator groups will be tested using survival analysis methods. Kaplan-Meier survival curves will be used to visualize the risk of the outcomes between intervention and comparator up to five years, and Cox modelling will be used to adjust for residual confounding and examine whether differences in risk are significant between intervention and comparator groups. The Cox models will include a variable for treatment (intervention versus comparator), sex, and a sex-treatment interaction term. The analyses will be conducted separately for each of the three secondary data sources. To evaluate our secondary hypothesis of whether the target trial emulation studies in the three data sources are aligned, we will compute 3 binary metrics for each outcome of interest: 1) full statistical significance agreement: treatment effect estimates and 95% confidence intervals (CIs) on the same side of the null, 2) estimate agreement: treatment effect estimates fell within the 95% CI of one another; and 3) standardized difference agreement: standardized differences between treatment effect estimates.
- Conditions
- Cardiovascular Kidney Metabolic Syndrome
- Being tested
- Intervention, Active Comparator
- Keywords
- GLP-1, SGLT-2, CKMS, CKMH, target trial, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDrug
GLP-1RA and/or SGLT2i adult users with ≥1 prescription for the intervention GLP-1RA or SGLT2i medications (including combination drugs or mixed therapies with comparator medications).
GLP-1RAs include: Exenatide, Liraglutide, Semaglutide, Dulaglutide, Lixisenatide, Albiglutide, Tirzepatide.
SGLT2is include: Canagliflozin, Dapagliflozin, Bexagliflozin, Empagliflozin, Ertugliflozin, Sotagliflozin.
Active ComparatorDrug
DPP4i or Oral Obesity Agent adult users with ≥1 prescription for the comparator DPP4i or Oral Obesity Agent medications AND no intervention GLP-1RA or SGLT2i prescriptions in first 30 days of follow up.
DPP4is include: Alogliptin, Saxagliptin, Linagliptin, Sitagliptin.
Oral Obesity Agents include: Orlistat, Naltrexone-bupropion, Phentermine-topiramate, Phentermine, Diethylpropion, Bupropion (off-label), Topiramate (off-label)
| Study group | Role | What they receive |
|---|---|---|
| Marketscan Cohort | Merative MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases are nationally representative U.S. claims databases of commercially insured patients. The databases include deidentified inpatient, outpatient, prescription drug, procedure, and enrollment records of beneficiaries, dependents, and retirees covered under a variety of fee-for-service and managed care health plans. This database includes >250 million privately insured individuals and older individuals enrolled in Medicare with an employer sponsored Medigap plan. Data from 2012 to 2022 will be used in DASH-CKMS. Receives: Drug: Intervention; Drug: Active Comparator | |
| All of Us Cohort | All of Us is a unique de-identified dataset administered by the U.S. National Institutes of Health (NIH) containing data from surveys, genomic analyses, electronic health records (EHR), physical measurements, and wearables to study the full range of factors that influence health and disease. All of Us is committed to recruiting a diverse participant pool that includes groups historically underrepresented in healthcare research. To date, about 45% of All of Us participants are racial and ethnic minorities, and over 80% are underrepresented in biomedical research overall. As of December 2024, there are more than 574,000 patient participants in All of Us who completed baseline surveys, provided physical measurements, and donated at least one biospecimen sample, and nearly 850,000 participants who have consented to join the program. Receives: Drug: Intervention; Drug: Active Comparator | |
| Lifescale Cohort | LifeScale data is an institution-scale clinical data warehouse from the Ohio State University Wexner Medical Center (OSUWMC) and Nationwide Children's Hospital (NCH). The data is a limited de-identified copy of the OSU/NCH Caboodle clinical data warehouse mediated by an honest broker and governed under a comprehensive Institutional Review Board (IRB) protocol. Receives: Drug: Intervention; Drug: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-Point major adverse cardiovascular event (3P-MACE)
Any of the following events:
- Nonfatal myocardial infarction
- Nonfatal stroke
- Death within 14 days of myocardial infarction, ischemic stroke, heart failure, acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention
Measured: Up to 5 years
Secondary outcomes (11)
All-cause Mortality
evidence of death from any cause
Measured: Up to 5 years
Advancing CKMS stage
advancing from the baseline CKMS stage
Measured: Up to 5 Years
stroke
Measured: up to 5 years
Myocardial Infarction
Measured: up to 5 years
Incident coronary heart disease diagnosis
Measured: up to 5 years
Incident peripheral artery disease diagnosis
Measured: up to 5 years
Atrial fibrillation diagnosis
Measured: up to 5 years
renal failure
Measured: up to 5 years
kidney transplant
Measured: up to 5 years
kidney dialysis
Measured: up to 5 years
heart failure
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start15 Sep 2025
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Kidney Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 23,280,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Daniel Walker, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188545
- Sponsor's protocol ID
- STUDY20250372
- Acronym
- DASH-CKMH
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
- ClinicalTrials.gov ID
- NCT07188545
- Acronym / sponsor ID
- DASH-CKMH / STUDY20250372
- Conditions
- Cardiovascular Kidney Metabolic Syndrome
- Keywords
- GLP-1, SGLT-2, CKMS, CKMH, target trial, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 23,280,000 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 23 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Complex pathophysiological interactions among obesity, metabolic risk factors, chronic kidney disease (CKD), and the cardiovascular system lead to poor cardiovascular-kidney-metabolic health (CKMH), which is a major determinant of premature morbidity and mortality. Poor CKMH may lead to cardiovascular-kidney-metabolic syndrome (CKMS) - the five-stage framework introduced by The American Heart Association (AHA) which accounts for the critical overlap between cardiorenal syndrome and cardiometabolic disease.
Evidence from randomized controlled trials shows glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter-2 inhibitors (SGLT2is) may improve CKMH in individuals with Type 2 Diabetes (T2D) and/ or obesity. However, there is modest evidence suggesting differential effectiveness of GLP-1RA and SGLT2i drugs between males and females. The extent of these sex-based differences is currently unknown. In part, this may be due to underrepresentation of females in clinical trials. Exploring sex-based differences in GLP-1RA and SGLT2i treatment on CKMH outcomes is important to inform CKMS treatment and equity in CKMH.
Robust secondary data sources present the opportunity to elucidate sex heterogeneity in GLP-1RA and SGLT2i treatment on CKMH outcomes. Using a target-trial emulation design, this study aims to observe differences in long-term CKMH outcomes between patients treated by GLP-1RA and SGLT2i medications versus those treated with active comparator medications, and whether there is an observed interaction between sex and treatment.
Detailed description
A target-trial design will be conducted in three sources of secondary data: 1)Merative Marketscan (claims-based data derived from commercial insurers), 2) All of Us (public database of Electronic Health Record [EHR] and survey data), and 3) LifeScale (EHR- derived from The Ohio State University Wexner Medical Center).
To construct a clinically similar comparator group, we opted for patients treated with active comparator medications with similar indications to the GLP-1RA and SGLT2i intervention medications. The intervention group is defined as patients with any exposure to the intervention medications, and the comparator group is defined as exposure to the comparator medications with no exposure to the intervention medications in the 30 days following index.
To balance baseline characteristics between intervention and comparator groups, for each cohort established in the three secondary data sources we will apply propensity score matching. Matching variables will include the following confounders: index age, U.S. region, race/ethnicity (where available), rurality, insurance type, Charlson comorbidity index score, index year, Medicaid expansion status in state of residence. Match quality will be assessed by examining standardized mean differences (SMDs) of matching variables by treatment and control, with SMD ≤ 10% indicating a well-balanced cohort after matching.
The primary outcome of interest is 3-P MACE (three-point major adverse cardiovascular event), defined as any of the following: nonfatal myocardial infarction, nonfatal stroke, or cardiac-related death. Secondary outcomes include: all-cause mortality, advancing CKMS stage, stroke, myocardial infarction, incident coronary heart disease diagnosis, incident peripheral artery disease diagnosis, atrial fibrillation diagnosis, renal failure, kidney transplant, and kidney dialysis.
Primary and secondary outcomes are time-to-event variables; thus, differences in risk of outcomes between intervention and comparator groups will be tested using survival analysis methods. Kaplan-Meier survival curves will be used to visualize the risk of the outcomes between intervention and comparator up to five years, and Cox modelling will be used to adjust for residual confounding and examine whether differences in risk are significant between intervention and comparator groups. The Cox models will include a variable for treatment (intervention versus comparator), sex, and a sex-treatment interaction term. The analyses will be conducted separately for each of the three secondary data sources. To evaluate our secondary hypothesis of whether the target trial emulation studies in the three data sources are aligned, we will compute 3 binary metrics for each outcome of interest: 1) full statistical significance agreement: treatment effect estimates and 95% confidence intervals (CIs) on the same side of the null, 2) estimate agreement: treatment effect estimates fell within the 95% CI of one another; and 3) standardized difference agreement: standardized differences between treatment effect estimates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Marketscan Cohort | – | Drug: Intervention, Drug: Active ComparatorMerative MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases are nationally representative U.S. claims databases of commercially insured patients. The databases include deidentified inpatient, outpatient, prescription drug, procedure, and enrollment records of beneficiaries, dependents, and retirees covered under a variety of fee-for-service and managed care health plans. This database includes >250 million privately insured individuals and older individuals enrolled in Medicare with an employer sponsored Medigap plan. Data from 2012 to 2022 will be used in DASH-CKMS. |
| All of Us Cohort | – | Drug: Intervention, Drug: Active ComparatorAll of Us is a unique de-identified dataset administered by the U.S. National Institutes of Health (NIH) containing data from surveys, genomic analyses, electronic health records (EHR), physical measurements, and wearables to study the full range of factors that influence health and disease. All of Us is committed to recruiting a diverse participant pool that includes groups historically underrepresented in healthcare research. To date, about 45% of All of Us participants are racial and ethnic minorities, and over 80% are underrepresented in biomedical research overall. As of December 2024, there are more than 574,000 patient participants in All of Us who completed baseline surveys, provided physical measurements, and donated at least one biospecimen sample, and nearly 850,000 participants who have consented to join the program. |
| Lifescale Cohort | – | Drug: Intervention, Drug: Active ComparatorLifeScale data is an institution-scale clinical data warehouse from the Ohio State University Wexner Medical Center (OSUWMC) and Nationwide Children's Hospital (NCH). The data is a limited de-identified copy of the OSU/NCH Caboodle clinical data warehouse mediated by an honest broker and governed under a comprehensive Institutional Review Board (IRB) protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data for this study comes from claims and electronic health records data sources. MarketScan and All of Us are nationally representative databases, and therefore contain patients from all over the US. LifeScale is a local database from The Ohio State University Wexner Medical Center (OSUWMC) and contains patients who seek care at OSUWMC inpatient and outpatient facilities. Adult patients included in the study have evidence of CKMS stage 1 or 2, ≥1 prescription for a GLP-1RA, SGLT2i, DPP4i, or obesity medication, and at least 180 days of continuous database enrollment prior to the first prescription for any medication of interest. Patients will be excluded if they have evidence of stage 3 or 4 CKMS, cancer, renal replacement therapy, end stage renal disease, or solid organ transplant during the baseline period (180 days prior to index date), any history of type I diabetes, or missing sex information. These study criteria will be applied to each of the sources of secondary data to co
Key inclusion criteria (4 listed)
- Stage 1 or 2 CKMS at baseline
- At least one prescription for an intervention or comparator medication after CKMS diagnosis
- At least 180 days of continuous enrollment prior to the first prescription for any medication of interest (index date)
- Age 18+ at index date
Key exclusion criteria (8 listed)
- Stage 3 or 4 CKMS at baseline
- Medications of interest during baseline period
- Any history of type I diabetes
- Cancer at baseline
- Renal replacement therapy at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionGLP-1RA and/or SGLT2i adult users with ≥1 prescription for the intervention GLP-1RA or SGLT2i medications (including combination drugs or mixed therapies with comparator medications). GLP-1RAs include: Exenatide, Liraglutide, Semaglutide, Dulaglutide, Lixisenatide, Albiglutide, Tirzepatide. SGLT2is include: Canagliflozin, Dapagliflozin, Bexagliflozin, Empagliflozin, Ertugliflozin, Sotagliflozin. | Drug | All of Us Cohort, Lifescale Cohort, Marketscan Cohort |
| Active ComparatorDPP4i or Oral Obesity Agent adult users with ≥1 prescription for the comparator DPP4i or Oral Obesity Agent medications AND no intervention GLP-1RA or SGLT2i prescriptions in first 30 days of follow up. DPP4is include: Alogliptin, Saxagliptin, Linagliptin, Sitagliptin. Oral Obesity Agents include: Orlistat, Naltrexone-bupropion, Phentermine-topiramate, Phentermine, Diethylpropion, Bupropion (off-label), Topiramate (off-label) | Drug | All of Us Cohort, Lifescale Cohort, Marketscan Cohort |
Primary outcome
3-Point major adverse cardiovascular event (3P-MACE)
Time frame: Up to 5 years
Any of the following events: * Nonfatal myocardial infarction * Nonfatal stroke * Death within 14 days of myocardial infarction, ischemic stroke, heart failure, acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention
11 secondary outcomes
All-cause Mortality
Time frame: Up to 5 years
Advancing CKMS stage
Time frame: Up to 5 Years
stroke
Time frame: up to 5 years
Myocardial Infarction
Time frame: up to 5 years
Incident coronary heart disease diagnosis
Time frame: up to 5 years
Incident peripheral artery disease diagnosis
Time frame: up to 5 years
Atrial fibrillation diagnosis
Time frame: up to 5 years
renal failure
Time frame: up to 5 years
kidney transplant
Time frame: up to 5 years
kidney dialysis
Time frame: up to 5 years
heart failure
Time frame: up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Kidney Metabolic Syndrome, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Point major adverse cardiovascular event (3P-MACE) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.