Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes
D1ANA
1 other identifier
interventional
75
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
July 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
July 15, 2026
July 1, 2026
2 years
June 18, 2026
July 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Change in percent body weight
Measured by a calibrated digital scale
From baseline to 6 months
Secondary Outcomes (22)
Change in glycated hemoglobin
From baseline to 6 months
Change in continuous glucose monitoring (CGM) parameters
From baseline to 6 months
Change in absolute body weight (kg)
From baseline to 6 months
Change in body mass index (BMI)
From baseline to 6 months
Change in anthropometric parameters
From baseline to 6 months
- +17 more secondary outcomes
Other Outcomes (9)
Change in gut microbiota
From baseline to 6 months
Change in DNA methylation
From baseline to 6 months
Change in inflammatory parameters
From baseline to 6 months
- +6 more other outcomes
Study Arms (3)
Moderate carbohydrate restriction
EXPERIMENTALModerate carbohydrate restriction (25-30% of total energy intake) plus 25% caloric restriction. Eating window ≥12 hours.
Time-restricted eating
EXPERIMENTAL8-hour early eating window (starting no later than 10 a.m.) plus 25% caloric restriction
Standard calorie restriction
ACTIVE COMPARATOR25% caloric restriction. Eating window ≥12 hours.
Interventions
Participants will follow a diet with moderate carbohydrate restriction (25-30%), together with 25% caloric restriction
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
Participants will follow a standard diet with 25% caloric restriction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virgen de la Victoria University Hospital
Málaga, Málaga, 29010, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Ignacio Martínez-Montoro, MD, PhD
Virgen de la Victoria University Hospital, Málaga, Spain
- PRINCIPAL INVESTIGATOR
Francisco J Tinahones, MD, PhD
Virgen de la Victoria University Hospital, Málaga, Spain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors and data analysts will be blinded to treatment allocation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2026
First Posted
June 25, 2026
Study Start
July 2, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
July 1, 2028
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share