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Can diet help people with type 1 diabetes lose weight? new study aims to find out

NCT ID NCT07667504

Disease control Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Updated 2 times

Summary

This study compares three diets for weight loss in adults with type 1 diabetes who are overweight or obese. Participants will follow either a moderate carbohydrate restriction, an early time-restricted eating plan, or a standard calorie-restricted diet. The goal is to see which approach works best and is safe for managing weight in this group.

What this could mean

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

Active substance
dietary interventions (moderate carbohydrate restriction, early time-restricted eating, standard calorie restriction)
What this could lead to
If successful, this could provide safe and effective dietary strategies for weight loss in people with type 1 diabetes, helping reduce complications.
What could go wrong
This is a small early-stage trial with only 75 participants, so results may not apply to everyone. Dietary changes can be hard to follow long-term, and weight loss might not be sustained.

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 75 people

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

Started

Jul 2026

Expected to finish

Jul 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 65 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: * T1D treated with intensive insulin therapy (multiple daily insulin injections or continuous subcutaneous insulin infusion systems) * HbA1c 6.5-9% * BMI ≥ 25 and ≤ 45 kg/m2 * Active prescription and use of CGM * Active prescription for glucagon Exclusion Criteria: * Pregnancy, pregnancy planning, or breastfeeding * Forms of diabetes other than T1D, or T1D duration \< 1 year * Previous cardiovascular events (acute myocardial infarction or stroke), heart failure, unstable coronary artery disease, chronic kidney disease with estimated glomerular filtration rate ≤ 30 mL/min/m², cirrhosis, or presence of active cancer * Unstable diabetes, episodes of glycemic decompensation (diabetic ketoacidosis) or severe hypoglycemia (level 3) within the past year. * Planned change in treatment during the study (switching from multiple daily insulin injections to continuous insulin infusion, or vice versa) * Use of sodium-glucose cotransporter 2 inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists, GLP-1/GIP agonists, or other medications that may influence weight loss * Having experienced a change in body weight greater than 5% within the 3 months before screening * Following any form of diet prior to inclusion, carbohydrate restriction, or intermittent fasting * History of eating disorders or alcohol abuse * Inability to follow the dietary recommendations * Presence of other conditions that, in the investigator's judgment, may compromise participation in the study.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight type 1 diabetes mellitus

As listed by the trial registrant

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

Obesity & overweight Type 1 diabetes (T1D)

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

  • Virgen de la Victoria University Hospital

    RECRUITING

    Málaga, Málaga, 29010, Spain

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