Type 1 Diabetes (T1D) Clinical Trials

Find Type 1 Diabetes (T1D) Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Virgen de la Victoria University Hospital
RECRUITING
Málaga
Contact Information
Primary
José Ignacio Martínez-Montoro, MD, PhD
martinezmontoro@ibima.eu
+34 951032647
Time Frame
Start Date: 2026-07-02
Estimated Completion Date: 2028-07
Participants
Target number of participants: 75
Treatments
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.
Sponsors
Leads: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

This content was sourced from clinicaltrials.gov