Dietary changes to help adults with Type 1 diabetes and overweight see if moderate carbs, time-restricted eating, or regular calories work

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares three weight-management approaches in adults with T1D and overweight/obesity: moderate carbohydrate restriction, early time-restricted eating, and standard calorie restriction. Participants will have T1D managed with intensive insulin therapy, use CGM, and meet HbA1c and BMI criteria. The trial aims to determine which approach yields meaningful weight loss while maintaining glycemic control and safety. Outcomes likely include changes in weight, metabolic markers, and insulin requirements. The study is conducted at a single site in Málaga, Spain, led by a regional health research foundation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Virgen de la Victoria University Hospital
  Málaga, Málaga, Spain Recruiting

Study contacts

• Principal investigator: José Ignacio Martínez-Montoro, MD, PhD — Virgen de la Victoria University Hospital, Málaga, Spain
• Study coordinator: José Ignacio Martínez-Montoro, MD, PhD
• Email: martinezmontoro@ibima.eu
• Phone: +34 951032647

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.