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

NCT07667504 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-07-15

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes (T1D)
  • Obesity & Overweight

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

Sponsors & Collaborators

  • Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

    lead OTHER

Principal Investigators

  • José Ignacio Martínez-Montoro, MD, PhD · Virgen de la Victoria University Hospital, Málaga, Spain

  • Francisco J Tinahones, MD, PhD · Virgen de la Victoria University Hospital, Málaga, Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-02
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07667504 on ClinicalTrials.gov