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13-Year diabetes showdown: surgery vs. meds – which wins?

NCT ID NCT02328599

Knowledge-focused Sponsor: Ali Aminian 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study combines data from four earlier trials to track 262 adults with type 2 diabetes and obesity for up to 13 years. Researchers want to see if bariatric surgery keeps blood sugar under control longer than medical or lifestyle changes. Participants were originally in randomized studies and are now being followed to measure long-term diabetes remission and blood sugar levels.

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

262 people

The number who actually took part.

Started

Apr 2018

Finished

Feb 2024

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

Subjects who were previously enrolled in a Randomized Control Trial (RCT) at one of the four participating sites who initiated one of the intervention procedures - bariatric surgery or medical/lifestyle therapy.

Ages

20 to 65 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: * Original inclusion criteria for participation in the RCTs at all sites included: * Candidate for general anesthesia or unsupervised exercise. * Age ≥20 and ≤65 years. * Body mass index \>27 and ≤45 kg/m2. * Diagnosis of type 2 diabetes confirmed by either requiring diabetes medication and/or having elevated glycemia based on HbA1c, fasting plasma glucose, and/or oral glucose tolerance test (OGTT) results, according to American Diabetes Association criteria. * Ability and willingness to participate in the study and agree to any of the research arms. * Able to understand the options and to comply with the requirements of each program. * Negative urine pregnancy test at screening and baseline visits (prior to surgery) for women of childbearing potential (i.e., biologically capable of becoming pregnant). Exclusion Criteria: * Subjects who were randomized in one of the four RCTs but never initiated intervention / did not receive randomized treatment * Refusal to sign informed consent

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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.

Obesity Type 2 diabetes mellitus

Contacts and locations

Locations

  • Cleveland Clinic Digestive Disease Institute

    Cleveland, Ohio, 44195, United States

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215, United States

  • University of Pittsburg Medical Center

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Washington

    Seattle, Washington, 98108, United States

More trials for these conditions

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