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

Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Study ID
NCT07667504
Status
Recruiting
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Conditions

  • Obesity & Overweight
  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Moderate carbohydrate restriction — BEHAVIORAL
    Participants will follow a diet with moderate carbohydrate restriction (25-30%), together with 25% caloric restriction
  • Early time-restricted eating — BEHAVIORAL
    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 restriction — BEHAVIORAL
    Participants will follow a standard diet with 25% caloric restriction

Study Details

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.

Key Dates

First listed
Jun 25, 2026
Start date
Jul 2, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
75 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Moderate carbohydrate restriction
    Moderate carbohydrate restriction (25-30% of total energy intake) plus 25% caloric restriction. Eating window ≥12 hours.
  • Experimental: Time-restricted eating
    8-hour early eating window (starting no later than 10 a.m.) plus 25% caloric restriction
  • Active Comparator: Standard calorie restriction
    25% caloric restriction. Eating window ≥12 hours.

Primary Outcome Measure

Change in percent body weight [ Time Frame: From baseline to 6 months ]

Central Contacts

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