Type 2 DiabetesNCT07271043
Nutrition+: Effect of a High-Protein Diabetes Formula on Body Composition in Type 2 Diabetes Patients Treated With Incretin Mimetics
A study testing protein supplement in people with Type 2 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
A randomized clinical study to assess the efficacy of a high-protein diabetes specific formula (HPDSF) on lean muscle mass in overweight and obese patients with type 2 diabetes who are initiating treatment with incretin-mimetic drugs. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- protein supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Subject is between 18-75 years of age
- Subject was diagnosed with type 2 diabetes at least 3 months prior to screening
- 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®)
- Body mass index (BMI) is ≥ 25 kg/m2
Who cannot join
- Subject has type 1 diabetes mellitus
- Subject with estimated glomerular filtration rate <60 milliliters/minute/1.73 m²,
- Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
- History of acute kidney injury (AKI) during the 6 months prior to screening g.
- Intolerance or allergy to HP-DSF shake or to any of its ingredients
- Women who are pregnant or lactating or expect to be pregnant or lactating during the study period.
- Women of childbearing potential who are not using highly effective contraceptive methods.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Marwa Al-Badri, MD, 6179758258, marwa.albadri@joslin.harvard.edu
Osama Hamdy, MD., PhD
About this study
Official title: Evaluating the Efficacy of High-Protein Diabetes Specific Formula (HP-DSF) on Body Composition in Overweight/Obese Patients With Type 2 Diabetes Treated With Incretin Mimetic Drugs
A randomized clinical study to assess the efficacy of a high-protein diabetes specific formula (HPDSF) on lean muscle mass in overweight and obese patients with type 2 diabetes who are initiating treatment with incretin-mimetic drugs.
- Conditions
- Type 2 Diabetes
- Being tested
- protein supplement
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein supplementDietary supplement
HP-DSF shakes provided by Abbott Nutrition
| Study group | Role | What they receive |
|---|---|---|
| Participants will be instructed to drink two HP-DSF shakes | Experimental | Not described Receives: Dietary Supplement: protein supplement |
| Participants in this control group will follow the regular standard of diabetes care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lean muscle mass from baseline
Measured: Endpoints will be analyzed at three months and six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jan 2026
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Osama Hamdy, MD, PhD, Principal investigator, Joslin Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271043
- Sponsor's protocol ID
- STUDY00000322
- Status last verified
- May 2026
- First submitted
- 25 Nov 2025
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of High-Protein Diabetes Specific Formula (HP-DSF) on Body Composition in Overweight/Obese Patients With Type 2 Diabetes Treated With Incretin Mimetic Drugs
- ClinicalTrials.gov ID
- NCT07271043
- Acronym / sponsor ID
- STUDY00000322
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Dec 2025 (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.
A randomized clinical study to assess the efficacy of a high-protein diabetes specific formula (HPDSF) on lean muscle mass in overweight and obese patients with type 2 diabetes who are initiating treatment with incretin-mimetic drugs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants will be instructed to drink two HP-DSF shakes | Experimental | Dietary Supplement: protein supplement |
| Participants in this control group will follow the regular standard of diabetes care | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is between 18-75 years of age
- Subject was diagnosed with type 2 diabetes at least 3 months prior to screening
- 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®)
- Body mass index (BMI) is ≥ 25 kg/m2
Key exclusion criteria (8 listed)
- Subject has type 1 diabetes mellitus
- Subject with estimated glomerular filtration rate <60 milliliters/minute/1.73 m²,
- Urine albumin-to-creatinine ratio (UACR) of 300 mg/g or higher
- History of acute kidney injury (AKI) during the 6 months prior to screening g.
- Intolerance or allergy to HP-DSF shake or to any of its ingredients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein supplementHP-DSF shakes provided by Abbott Nutrition | Dietary supplement | Participants will be instructed to drink two HP-DSF shakes |
Primary outcome
Change in lean muscle mass from baseline
Time frame: Endpoints will be analyzed at three months and six months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
Osama Hamdy, MD, PhD principal investigator
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing protein supplement in people with Type 2 Diabetes, run by Joslin Diabetes Center at 1 site in United States.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa Al-Badri, MD (6179758258, marwa.albadri@joslin.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lean muscle mass from baseline (time frame: Endpoints will be analyzed at three months and six months.). 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 29 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.