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Surgery vs. diet: which tames diabetes better?

NCT ID NCT01047735

Disease control Sponsor: University of Pittsburgh 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two types of weight-loss surgery (gastric bypass and gastric banding) with an intensive diet and exercise program for controlling type 2 diabetes in moderately obese adults aged 25 to 55. The goal is to see which approach works best for improving diabetes and weight loss. It is a small, early-stage trial to test whether a larger study is possible.

What this could mean

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

Active substance
Roux-en-Y Gastric Bypass surgery and Laparoscopic Adjustable Gastric Banding
What this could lead to
If successful, this could show that surgery is more effective than lifestyle changes for controlling diabetes in moderately obese patients, potentially leading to better long-term outcomes.
What could go wrong
This is a small, early feasibility study with only 69 participants, so results may not apply to everyone. Surgery carries risks like infection and nutrient deficiencies, and diabetes may not fully resolve.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

69 people

The number who actually took part.

Started

Sep 2009

Expected to finish

Jul 2028

An estimate. End dates often move.

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.

Ages

25 to 55 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: * Age 25 to 55 years * Mild to moderate obesity with a BMI between 30 and 40 kg/m2 * For potential subjects with BMI 35 to 40 kg/m2: T2DM confirmed by either a documented fasting blood glucose \> 126 mg/dl OR treatment with an anti-diabetic medication * For potential subjects with BMI 30 to 35 kg/m2: T2DM that is difficult to control medically and is recommended for the study by the subject's endocrinologist AND treatment with an anti-diabetic medication * Willingness to be randomized to a surgical intervention Exclusion Criteria: * Prior bariatric or foregut surgery * Poor overall general health * Impaired mental status * Drug and/or alcohol addiction * Current smoking * Pregnant or plans to become pregnant * Type 1 Diabetes Mellitus * Portal hypertension and/or Cirrhosis * Failed study-related nutrition or psychological assessment * Current participation in any other research study * Inability to provide informed consent * Unlikely to comply with study protocol * Unable to communicate with study staff * Unable to exercise (walk a city block or a flight of stairs)

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Conditions

The condition(s) this trial relates to.

atherosclerosis Behavior blindness (disorder) Body Weight cardiovascular disorder Death diabetes mellitus Digestive System Diseases disease hypertensive disorder Inflammation Insulin Resistance kidney failure liver disorder metabolic dysfunction-associated steatotic liver disease morbid obesity Motor Activity myocardial infarction neoplasm Obesity obesity disorder type 2 diabetes mellitus Weight Loss

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

  • William F Gourash

    Pittsburgh, Pennsylvania, 15213, United States

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