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Eating Approaches for Weight Loss in Adults With Type 1 Diabetes and Overweight

Tests 3 eating approaches for weight loss in adults with type 1 diabetes.

Plain-language title generated from the registry record
Registry title: Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes

Key facts

Where
Málaga, SpainSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with type 1 diabetes who are overweight or obese. It compares three diets for weight loss.

Age
18 to 65 years
Sex
All sexes
Disease stage
Type 1 diabetes treated with intensive insulin therapy (multiple daily injections or an insulin pump). HbA1c 6.5-9% (48–75 mmol/mol). BMI 25 to 45 kg/m2.
Earlier treatment
Must use a CGM (continuous glucose monitor) and have an active prescription for glucagon. Cannot have used SGLT2 inhibitors, GLP-1 or GLP-1/GIP drugs, or other weight-affecting medicines. Cannot have followed any diet, carbohydrate restriction or intermittent fasting before joining.
Biomarker or test result
HbA1c 6.5-9% (48–75 mmol/mol)

Main reasons for not taking part

  • Pregnancy, planning pregnancy, or breastfeeding
  • Diabetes other than type 1, or type 1 diabetes for less than 1 year
  • Heart attack, stroke, heart failure, advanced kidney disease, cirrhosis, or active cancer
  • Diabetic ketoacidosis or severe hypoglycemia (level 3) in the past year
  • Body weight change of more than 5% in the 3 months before screening

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT07667504, who can take part

Where in Spain

  • Virgen de la Victoria University HospitalMálaga, SpainContact: José Ignacio Martínez-Montoro, MD, PhD (principal investigator)Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Trial code
NCT07667504
Record updated
15 July 2026
Original description
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.Read full original descriptionShow less

Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes: The D1ANA Study

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.

Inclusion: 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: 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; 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; 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; 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.

ClinicalTrials.gov NCT07667504