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NOT YET RECRUITING
NCT07667504
NA

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

View on ClinicalTrials.gov

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. In this study, we 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.

Official title: Dietary Approaches for the Management of Overweight and Obesity in Type 1 Diabetes: The D1ANA Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-07

Completion Date

2028-07

Last Updated

2026-06-25

Healthy Volunteers

No

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

Locations (1)

Virgen de la Victoria University Hospital

Málaga, Málaga, Spain