Can cutting carbs beat diabetes? new study says maybe

NCT ID NCT05330247

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Updated 2 times

Summary

This study looks at whether a low-carb, high-protein diet can help people with type 2 diabetes control their blood sugar and lose weight better than a standard diabetes diet. About 100 overweight or obese adults with type 2 diabetes will follow one of the two diets for 12 months. Researchers will measure changes in blood sugar, body weight, and other health markers.

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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

100 people

The number who actually took part.

Started

Sep 2022

Finished

Jan 2026

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: * Men or postmenopausal women aged 18-75 years. Menopause is defined as \>12 months without menses * Overweight or obesity with Body Mass Index (BMI) \>25 kg/m2 * Type 2 diabetes with HbA1c between 48 mmol/mol and 75 mmol/mol (6.5%-9.0%) * Treated with or without metformin, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose cotransporter 2 (SGLT-2) inhibitors and/or glucagon-like peptide 1 receptor agonists (GLP-1RA) * Nonsmokers or having quitted smoking \>1 year before the study * Acceptance of regulation of antidiabetic, antihypertensive, and lipid-lowering medications by Cut-DM endocrinologists only Exclusion Criteria: * Ongoing insulin or insulin analog therapy * Severe gut disease as evaluated by the principal investigator e.g. Crohn's disease, Ulcerative colitis, Celiac disease etc. * Extensive surgery to the gut e.g. bariatric surgery, colectomy etc. * Severe heart disease as evaluated by the principal investigator e.g. angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV) * Severe renal impairment (eGFR\<45 ml/min/1.73 m2 or urine albumin / creatinine ratio \> 300 mg/g) * Severe hepatic impairment as evaluated by the principal investigator (measure of alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) * Cancer within the last 5 years (except basal cell skin cancer or squamous cell skin cancer) * Psychiatric disease, e.g. a history of major depressive or other severe psychiatric disorders * Ongoing systemic corticosteroid treatment, e.g. prednisolone * Reported or documented food allergy, food intolerance, or currently following a particular eating pattern or strong food preferences, not compatible with study participation * Reported or documented alcohol consumption exceeding the recommendations from The Danish Health Authorities * Ongoing treatment with sulfonylureas and/or thiazolidinediones due to the risk of hypoglycemia unless discontinuation is possible, in which case a \>3-month wash-out is mandatory * Hemoglobin \<7 mmol/L for men and \<6 mmol/L for women * Inability, physically and/or mentally, to comply with the procedures required by the study protocol, as evaluated by the principal investigator * Weight change ≥5% the preceding 3 months of screening * Participation in other on-going clinical trials

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Bispebjerg Hospital

    Copenhagen, Copenhagen NV, 2400, Denmark

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