Type 2 Diabetes MellitusM6NCT06355219
Macrovascular and Microvascular Morbidity and Mortality After Metabolic Surgery Versus Medicines
An observational study of Type 2 Diabetes Mellitus and Obesity, run by Ali Aminian.
Trial summary
The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity, Microvascular Disease
- How many people
- 3,932 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 20 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with obesity (defined by body mass index [BMI] ≥30 kg/m^2) and T2DM who underwent metabolic surgery at Cleveland Clinic Health System (CCHS) from 2010 to 2017 were compared with similar patients who continuously received GLP-1 RA for at least 2 years. The study used Cleveland Clinic electronic health records (EHR), including Surescripts dispensed prescription records. Follow-up ended on December 31, 2022. To minimize the effects of confounding factors, a doubly robust estimation combining the overlap weighting and outcome regression will be utilized to compare primary and secondary end points in surgical and GLP-1RA groups.
Who may be able to join
- BMI>=30 kg/m^2
- Type 2 Diabetes Mellitus
- 18-75 y/o
- Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) (Surgical Cohort) at CCHS hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017
- For the GLP-1RA Group:
- Follow-up of at least 30 days after the assigned index date
Show all 9Show fewer
- Did not meet any of the exclusion criteria for surgical patients (see below)
- Did not have metabolic surgery prior to assigned index date.
- Continuously received GLP-1 RA for ≥2 years (prescription order for GLP-1 RA placed between January 1, 2010, and December 31, 2017, as well as ≥ 3 documented prescription fills within 1 year before their assigned index date and ≥ 3 fills within 1 year after their index date)
Who cannot join
- History of solid organ transplant
- Cardiac ejection fraction <20% any time before index date
- Active cancer
- Cancer code within 1 year before index date
- ED admission within 5 days before index date
- Dialysis or estimated glomerular filtration rate (eGFR) <20 before index date.
- Received care in CCHS locations other than in Ohio and Florida.
About this study
Official title: Macrovascular and Microvascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus GLP-1 Receptor Agonists
The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths.
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Microvascular Disease, Macrovascular Disease, Major Adverse Cardiovascular Events, Nephropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Kidney Diseases, Retinal Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Surgery | Patients aged 18 years to 75 years, who had a BMI ≥30 and T2DM at the time of surgery, and who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) at Cleveland Clinic Health System(CCHS) hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017. | |
| GLP-1 RAs | Non-surgical patients at CCHS who at randomly assigned index dates had T2DM and obesity, follow-up of at least 30 days after the assigned index date, did not meet any of the exclusion criteria for surgical patients, and did not have metabolic surgery prior to the assigned index date, who continuously received GLP-1 RA for ≥2 years, defined by prescription order for GLP-1 RA placed between January 1, 2010, and December 31, 2017, as well as ≥ 3 documented prescription fills within 1 year before their assigned index date and ≥ 3 fills within 1 year after their index date. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality Rate
Death from all causes percentage
Measured: After surgical or assigned index date to Dec 31, 2022
Secondary outcomes (3)
Incidence of MACE
Incident major adverse cardiovascular events (MACE, composite of 4 outcomes), defined as the first occurrence of coronary artery events (unstable angina, myocardial infarction, or coronary intervention/surgery), cerebrovascular events (ischemic stroke, hemorrhagic stroke, or carotid intervention/surgery), heart failure, or atrial fibrillation.
Measured: After surgical or assigned index date to Dec 31, 2022
Incidence of Nephropathy
Onset of ≥40% sustained decline in eGFR compared with baseline (calculated using the 2021 CKD-EPI equation), onset of sustained eGFR <15 mL/min/1.73 m^2, initiation of dialysis, or kidney transplant.
Measured: After surgical or assigned index date to Dec 31, 2022
Incidence of Retinopathy
(1) First occurrence of retinopathy in patients who did not have such events at baseline or (2) progression to a more severe form of retinopathy in those with baseline retinopathy
Measured: After surgical or assigned index date to Dec 31, 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start1 Jan 2010
- Primary completion31 Dec 2022
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 3,932 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ali Aminian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ali Aminian, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355219
- Sponsor's protocol ID
- IRB #19-066
- Acronym
- M6
- Status last verified
- May 2024
- First submitted
- 29 Mar 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macrovascular and Microvascular Outcomes in Patients With Type 2 Diabetes and Obesity: Comparison of Metabolic Surgery Versus GLP-1 Receptor Agonists
- ClinicalTrials.gov ID
- NCT06355219
- Acronym / sponsor ID
- M6 / IRB #19-066
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Microvascular Disease, Macrovascular Disease, Major Adverse Cardiovascular Events, Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,932 participants (actual)
- Lead sponsor
- Ali AminianUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 9 Apr 2024 (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.
The goal of this study is to compare the impact of metabolic surgery and a class of anti-diabetes medications (Glucagon-like peptide-1 receptor agonists,GLP-1 RAs) on occurrence of diseases involving small and large vessels such as heart disease, kidney disease, and disease of the retina (a part of the eye), as well as deaths.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic Surgery | – | –Patients aged 18 years to 75 years, who had a BMI ≥30 and T2DM at the time of surgery, and who underwent Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) at Cleveland Clinic Health System(CCHS) hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017. |
| GLP-1 RAs | – | –Non-surgical patients at CCHS who at randomly assigned index dates had T2DM and obesity, follow-up of at least 30 days after the assigned index date, did not meet any of the exclusion criteria for surgical patients, and did not have metabolic surgery prior to the assigned index date, who continuously received GLP-1 RA for ≥2 years, defined by prescription order for GLP-1 RA placed between January 1, 2010, and December 31, 2017, as well as ≥ 3 documented prescription fills within 1 year before their assigned index date and ≥ 3 fills within 1 year after their index date. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity (defined by body mass index [BMI] ≥30 kg/m^2) and T2DM who underwent metabolic surgery at Cleveland Clinic Health System (CCHS) from 2010 to 2017 were compared with similar patients who continuously received GLP-1 RA for at least 2 years. The study used Cleveland Clinic electronic health records (EHR), including Surescripts dispensed prescription records. Follow-up ended on December 31, 2022. To minimize the effects of confounding factors, a doubly robust estimation combining the overlap weighting and outcome regression will be utilized to compare primary and secondary end points in surgical and GLP-1RA groups.
Key inclusion criteria (9 listed)
- BMI>=30 kg/m^2
- Type 2 Diabetes Mellitus
- 18-75 y/o
- Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) (Surgical Cohort) at CCHS hospitals in Florida and Ohio between January 1, 2010, and December 31, 2017
- Follow-up of at least 30 days after the assigned index date
Key exclusion criteria (7 listed)
- History of solid organ transplant
- Cardiac ejection fraction <20% any time before index date
- Active cancer
- Cancer code within 1 year before index date
- ED admission within 5 days before index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause Mortality Rate
Time frame: After surgical or assigned index date to Dec 31, 2022
Death from all causes percentage
3 secondary outcomes
Incidence of MACE
Time frame: After surgical or assigned index date to Dec 31, 2022
Incidence of Nephropathy
Time frame: After surgical or assigned index date to Dec 31, 2022
Incidence of Retinopathy
Time frame: After surgical or assigned index date to Dec 31, 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Obesity, run by Ali Aminian.
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
All-cause Mortality Rate (time frame: After surgical or assigned index date to Dec 31, 2022). 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 21 May 2024.