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Type 1 Diabetes (T1D)D1ANANCT07667504

Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes

A study testing Moderate carbohydrate restriction, Early time-restricted eating and Standard calorie restriction in people with Type 1 Diabetes (T1D) and Obesity & Overweight, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes (T1D), Obesity & Overweight
What is being tested?
Moderate carbohydrate restriction, Early time-restricted eating and Standard calorie restriction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteSpain
Study dates
2 Jul 2026to Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

José Ignacio Martínez-Montoro, MD, PhD contact

+34 951032647

martinezmontoro@ibima.eu

Spain1 site, 1 recruiting

  • Virgen de la Victoria University Hospital

    Málaga, Málaga, 29010

    José Ignacio Martínez-Montoro, MD, PhD

    Francisco J Tinahones, MD, PhD

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Being tested
Moderate carbohydrate restriction, Early time-restricted eating, Standard calorie restriction
Medical subject headings
Diabetes Mellitus, Type 1, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moderate carbohydrate restrictionBehavioural

    Participants will follow a diet with moderate carbohydrate restriction (25-30%), together with 25% caloric restriction

  • Early time-restricted eatingBehavioural

    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

  • Standard calorie restrictionBehavioural

    Participants will follow a standard diet with 25% caloric restriction

Study groups in NCT07667504
Study groupRoleWhat they receive
Moderate carbohydrate restrictionExperimentalModerate carbohydrate restriction (25-30% of total energy intake) plus 25% caloric restriction. Eating window ≥12 hours.
Receives: Behavioral: Moderate carbohydrate restriction
Time-restricted eatingExperimental8-hour early eating window (starting no later than 10 a.m.) plus 25% caloric restriction
Receives: Behavioral: Early time-restricted eating
Standard calorie restrictionActive comparator25% caloric restriction. Eating window ≥12 hours.
Receives: Behavioral: Standard calorie restriction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in percent body weight

    Measured by a calibrated digital scale

    Measured: From baseline to 6 months

Secondary outcomes (22)

  1. Change in glycated hemoglobin

    Fasting blood samples. Glycated hemoglobin will be assessed by HPLC

    Measured: From baseline to 6 months

  2. Change in continuous glucose monitoring (CGM) parameters

    Parameters measured by CGM, including time in range, time below range, mean glucose, standard deviation of glucose, coefficient of variation of glucose, time above range, time in tight range, glucose management indicator

    Measured: From baseline to 6 months

  3. Change in absolute body weight (kg)

    Measured by a calibrated digital scale

    Measured: From baseline to 6 months

  4. Change in body mass index (BMI)

    Calculated as kg/m2

    Measured: From baseline to 6 months

  5. Change in anthropometric parameters

    Assessed by standard methods (waist circumference, hip circumference, waist-to-hip-ratio)

    Measured: From baseline to 6 months

  6. Change in body composition (fat mass, fat-free mass)

    Assessed by air displacement plethysmography

    Measured: From baseline to 6 months

  7. Change in systolic and diastolic blood pressure

    Measured by standard procedures

    Measured: From baseline to 6 months

  8. Change in insulin dose

    Assessed by the recording of basal insulin dose, bolus insulin dose, total insulin dose (IU/day, IU/kg/day)

    Measured: From baseline to 6 months

  9. Change in lipid profile

    Fasting blood samples, including several lipid parameters (e.g., total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides)

    Measured: From baseline to 6 months

  10. Change in hepatic profile

    Fasting blood samples including several liver parameters (e.g., aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase)

    Measured: From baseline to 6 months

  11. Change in estimated glucose disposal rate (eGDR)

    Insulin resistance will be calculated from waist circumference, hypertension status, and HbA1c

    Measured: From baseline to 6 months

  12. Change in eating behavior

    Assessed by the Three-Factor Eating Questionnaire - Revised 18 items (TEFQ-18)

    Measured: From baseline to 6 months

  13. Change in T1D-related distress

    Assessed by the Type1 Diabetes Distress Assessment System (T1-DDAS)

    Measured: From baseline to 6 months

  14. Change in treatment satisfaction

    Assessed by the Diabetes Treatment Satisfaction Questionnaire, status version (DTSQs) and change version (DTSQc)

    Measured: From baseline to 6 months

  15. Change in quality of life and general health

    Assessed by the EuroQol 5 dimensions 5 levels (EQ-5D-5L)

    Measured: From baseline to 6 months

  16. Change in sleep quality

    Assessed by the Pittsburgh Sleep Quality Index (PSQI) and by accelorometry

    Measured: From baseline to 6 months

  17. Change in ketonemia

    Measured by capillary blood β-hydroxybutyrate

    Measured: From baseline to 6 months

  18. Change in physical activity

    Assessed by the International Physical Activity Questionnaire and by accelorometry

    Measured: From baseline to 6 months

  19. Adverse events

    Assessed by systematic recording of adverse events throughout the study period

    Measured: From baseline to 6 months

  20. Change in resting energy expenditure

    Assessed by indirect calorimetry

    Measured: From baseline to 6 months

  21. Change in energy and nutrient intake

    Assessed by 24 h recalls

    Measured: From baseline to 6 months

  22. Dietary adherence

    Assessed by 24 h recalls and adherence logs

    Measured: From baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2026
  2. Study start2 Jul 2026
  3. Primary completionJul 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07667504
Sponsor's protocol ID
PI25/01601
Acronym
D1ANA
Status last verified
Jul 2026
First submitted
18 Jun 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Moderate carbohydrate restriction, Early time-restricted eating and Standard calorie restriction in people with Type 1 Diabetes (T1D) and Obesity & Overweight, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact José Ignacio Martínez-Montoro, MD, PhD (+34 951032647, martinezmontoro@ibima.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in percent body weight (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07667504.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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