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Diet over drugs? new study tests if meal replacements can cure diabetes

NCT ID NCT07270068

Disease control Sponsor: Winnie Chee Siew Swee 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a structured lifestyle program, including a total diet replacement phase, can help Malaysian adults with early type 2 diabetes achieve remission. 92 participants will be randomly assigned to either the intensive program or standard care. The goal is to see if more people can stop diabetes medication and maintain healthy blood sugar levels.

What this could mean

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

Active substance
Total Diet Replacement (a meal replacement plan) combined with a structured lifestyle program
What this could lead to
If successful, this could offer a drug-free way to reverse early type 2 diabetes in some people, reducing long-term health complications.
What could go wrong
This is a small, early-stage study (92 people) in one country, so results may not apply widely. The diet is very restrictive and may be hard to maintain long-term.

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 92 people

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

Started

Dec 2025

Expected to finish

Apr 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

18 to 70 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. Diagnosed diabetes for a duration of \< 3 years (diagnosis based on 2 recorded diagnostic-level tests, HbA1C and/or blood glucose) 2. Body mass index (BMI) \> 25 kg/m2 3. HbA1C level above \> 6.5% to 9% as per the last routine clinical check within 6 months 4. Currently being treated with one or more oral glucose lowering drugs Exclusion Criteria: 1. Type 1 DM 2. Type 2 DM on basal or multiple insulin injections 3. Recent routine HbA1C of \> 9% 4. Patients who in the past 6 months have weight loss exceeding 5 kg (such individuals may have difficulty losing additional weight) 5. Recent (last 12 weeks) or current use of medications/meal replacements for weight loss 6. Alcoholism or any substance abuse 7. History of bariatric surgery, small bowel resection, or extensive bowel resection 8. Chronic treatment with systemic corticosteroids. Use of hormone replacement therapy or oral contraceptives will not lead to exclusion 9. Severe hypertension on multiple drugs treatment 10. Currently pregnant or nursing and planning to get pregnant 11. Requiring hospitalization for depression or are on antipsychotic medications 12. Cancer requiring treatment for the past 5 years, except of non-melanoma skin cancers or cancers that have been clearly cured 13. HIV- positive (self-report) due to effects or weight and body composition of HIV and medications treating HIV 14. Cardiovascular disease (heart attack or procedure within past 3 months or participation in cardiac rehabilitation program within last 3 months, stroke or history/ treatment for transient ischemic attacks in the past 3 months, or documented history of pulmonary embolus for the past 6 months) 15. Renal disease - eGFR \< 60 ml/min (based MDRD) or currently receiving dialysis 16. Proliferative retinopathy and other severe diabetes complications 17. Diagnosed eating disorder or purging

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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

How to take part

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

  1. The places running it

    2 sites. 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

  • Hospital Putrajaya

    RECRUITING

    Kuala Lumpur, Putrajaya, 62250, Malaysia

  • Klinik Kesihatan Seremban

    RECRUITING

    Seremban, Negeri Sembilam, 70300, Malaysia

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