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Protein shake may protect muscle during diabetes Weight-Loss treatment

NCT ID NCT07271043

Disease control Sponsor: Joslin Diabetes Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a special high-protein shake can help overweight or obese adults with type 2 diabetes preserve lean muscle mass when they start taking GLP-1 drugs like Ozempic or Mounjaro. About 60 participants will be randomly assigned to drink the shake or follow standard care. The main goal is to see if the shake prevents muscle loss during weight reduction.

What this could mean

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

Active substance
high-protein diabetes specific formula (HP-DSF) shake
What this could lead to
If it works, this could show that adding a high-protein shake helps people with type 2 diabetes keep their muscle while losing weight on GLP-1 drugs.
What could go wrong
This is a small, early-stage study with only 60 participants. The supplement may not significantly preserve muscle, and results may not apply to everyone with diabetes.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2026

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

18 to 75 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: 1. Subject is between 18-75 years of age 2. Subject was diagnosed with type 2 diabetes at least 3 months prior to screening 3. Subject is about to start treatment with an IMD, a GLP-1 receptor agonist (RA) alone or a dual GLP-1/GIP RA. These treatments include either semaglutide (Ozempic®, Wegovy®), tirzepatide (Mounjaro®, Zepbound®), or dulaglutide (Trulicity®) 4. Body mass index (BMI) is ≥ 25 kg/m2 Exclusion Criteria: 1. Subject has type 1 diabetes mellitus 2. Subject with estimated glomerular filtration rate \<60 milliliters/minute/1.73 m², 3. Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher 4. History of acute kidney injury (AKI) during the 6 months prior to screening g. 5. Intolerance or allergy to HP-DSF shake or to any of its ingredients 6. Women who are pregnant or lactating or expect to be pregnant or lactating during the study period. 7. Women of childbearing potential who are not using highly effective contraceptive methods. \-

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

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

Diabete type 2 Type 2 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Joslin Diabetes Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

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