Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Moderate carbohydrate restriction, Early time-restricted eating, Standard calorie restriction.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Obesity & Overweight. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes: The D1ANA Study
Overview
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.
Interventions
- Behavioral Moderate carbohydrate restriction
Participants will follow a diet with moderate carbohydrate restriction (25-30%), together with 25% caloric restriction - Behavioral Early time-restricted eating
Participants will follow a standard diet with an 8-hour early eating window, starting no later than 10 a.m. (16-hour fast), together with 25% caloric restriction - Behavioral Standard calorie restriction
Participants will follow a standard diet with 25% caloric restriction
Primary outcome measures
- Change in percent body weight [Time frame: From baseline to 6 months]
Secondary outcome measures (12)
- Change in glycated hemoglobin [Time frame: From baseline to 6 months]
- Change in continuous glucose monitoring (CGM) parameters [Time frame: From baseline to 6 months]
- Change in absolute body weight (kg) [Time frame: From baseline to 6 months]
- Change in body mass index (BMI) [Time frame: From baseline to 6 months]
- Change in anthropometric parameters [Time frame: From baseline to 6 months]
- Change in body composition (fat mass, fat-free mass) [Time frame: From baseline to 6 months]
- Change in systolic and diastolic blood pressure [Time frame: From baseline to 6 months]
- Change in insulin dose [Time frame: From baseline to 6 months]
- Change in lipid profile [Time frame: From baseline to 6 months]
- Change in hepatic profile [Time frame: From baseline to 6 months]
- Change in estimated glucose disposal rate (eGDR) [Time frame: From baseline to 6 months]
- Change in eating behavior [Time frame: From baseline to 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Virgen de la Victoria University Hospital — Málaga
Identifiers
NCT: NCT07667504 · PI25/01601