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Could Weight-Loss surgery slash heart risks in diabetes?

NCT ID NCT03955952

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This study looks at whether bariatric (weight-loss) surgery can reduce the risk of heart attacks, strokes, heart failure, and death in people who have both type 2 diabetes and obesity. It compares people who had the surgery with those who received usual diabetes care. The goal is to see if surgery offers extra protection for the heart and blood vessels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Bariatric surgery (weight-loss surgery)
What this could lead to
If successful, this could show that weight-loss surgery is a powerful way to reduce serious heart problems and early death in people with type 2 diabetes and obesity.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by other factors. Surgery carries risks, and benefits may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

91,700 people

The number who actually took part.

Started

Jun 2019

Finished

Aug 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Type 2 diabetes patients with obesity (BMI\>=30) between 18-80 years old.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Type II diabetes * 18-80 years old * BMI\>=30 * HBA1c \>6.4 OR taking at lease one (1) diabetes medication (insulin or non-insulin) Exclusion Criteria: * History of liver, heart, or lung transplant * Emergency department admission within 5 days prior * Cancer diagnosis within 1 year prior * Any prior ejection fraction \<20% * Non-surgical controls were excluded if they died within 30 days after the index date (date of surgery for the bariatric patients) * Last follow-up date on or before the index date

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bariatric surgery candidate Obesity TYPE2 diabetes

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.