NCT07667504Recruiting
Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes
Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes: The D1ANA Study
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
Although type 1 diabetes (T1D) has traditionally been considered a disease associated with a lean phenotype, it is estimated that up to 2 out of 3 people living with T1D are overweight or obese, factors linked to an increased risk of complications in these patients. The available evidence regarding nutritional strategies for weight loss in T1D is very limited, and clinical trials are needed to determine how to effectively and safely promote weight loss in this population. In recent years, low-carbohydrate diets and several intermittent fasting protocols have demonstrated efficacy in promoting weight loss both in patients with type 2 diabetes and in patients with obesity without diabetes. This study will evaluate the efficacy of moderate carbohydrate restriction, time-restricted eating, and standard calorie restriction for weight loss in adults with T1D and overweight/obesity.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 18 Jun 2026
- Start date
- 2 Jul 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Diseases
- Obesity, Type 1 diabetes
- NCT number
- NCT07667504
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 2 Jul 2026 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Forms of diabetes other than T1D, or T1D duration \< 1 year
- Unstable diabetes, episodes of glycemic decompensation (diabetic ketoacidosis) or severe hypoglycemia (level 3) within the past year.
- History of eating disorders or alcohol abuse
- Presence of other conditions that, in the investigator's judgment, may compromise participation in the study.
Lab values
- 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
Other
- Pregnancy, pregnancy planning, or breastfeeding
- Planned change in treatment during the study (switching from multiple daily insulin injections to continuous insulin infusion, or vice versa)
- Inability to follow the dietary recommendations
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virgen de la Victoria University Hospital Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.