New study tests lifestyle fix for diabetes remission
NCT ID NCT07262788
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether a high-carbohydrate diet combined with exercise can help people with type 2 diabetes achieve remission. It involves 24 overweight adults recently diagnosed with diabetes who are not on insulin. The goal is to see if this approach is practical and safe, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- High-carbohydrate diet and exercise program
- What this could lead to
- If successful, this could show that a structured lifestyle change helps some people with type 2 diabetes manage or even reverse their condition without long-term medication.
- What could go wrong
- This is a very small feasibility study with only 24 participants, so results may not apply to everyone. It is not designed to prove effectiveness, only to test if the approach is practical.
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
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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
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Building on previous findings from T2D remission studies involving VLCD interventions, the study include individuals with recently diagnosed T2D who are overweight or obese and not receiving insulin therapy. This subgroup has demonstrated the greatest benefit from significant weight loss. Participants using GLP-1 receptor agonists (GLP-1 RAs) are eligible, provided their weight has been stable for at least three months prior to inclusion. Individuals on insulin therapy will be excluded. Allowing GLP-1 RA use enhances the study's generalizability, as approximately 29% of people with T2D in Denmark are currently treated with these medications. Inclusion Criteria: * Diagnosis of T2D. Treatment lifestyle changes, oral anti-diabetic medication including metformin, and/or sulfonylureas and/or DPP-4 inhibitors and/or SGLT2 inhibitors and/or incretin-based medication * HbA1c between 36-86 mmol/mol * T2D duration of ≤6 years * BMI ≥27 kg/m2 * Body weight changes over 3 months ≤3 kg Exclusion Criteria: * Insulin treatment within 6 months prior to screening (any type) * Heart failure (ejection fraction ≤40%) and treated with SGLT-2i (current or planned) * Cardiovascular disease, including previous heart attack or stroke, for which incretin-based therapy and/or an SGLT-2i has been prescribed. * Kidney disease (eGFR \<60 ml/min/1,73m² and/or albuminuria (≥30 mg/g) for at least three months) and treated with SGLT-2i (current or planned) * Physical comorbidity, which precludes the physical activity during intervention * Dietary restrictions or allergies making the participant unable to adhere to the dietary interventions * Unable to comply with trial procedures and/or interventions * Alcohol/drug abuse * Planned or present pregnancy/fertility treatment, or lack of contraception during reproductive age * Unstable psychiatric disease that is deemed to impede participation in the project * Diagnosed with binge eating disorder * Participation (present or planned) in other clinical trials including lifestyle or pharmacy trials for any condition * If HbA1c ≥60 mmol/mol and the participant is on 2 or more anti-diabetic drugs and has a positive GAD65 and/or stimulated C-peptide \<800 pM
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Steno Diabetes Center Copenhagen
RECRUITINGHerlev, Denmark, 2730, Denmark
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