Vey Low-Energy Ketogenic Therapy in Adults With Type 1 Diabetes and Obesity on Intensive Insulin Therapy Using Advanded Hybrid Closed Loop System

NARecruitingINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

January 16, 2025

Primary Completion Date

December 14, 2025

Study Completion Date

March 1, 2026

Conditions
Type 1 Diabetes (T1D)Obesity (Disorder)
Interventions
DIETARY_SUPPLEMENT

VLEKT

Participants will follow a Very Low-Energy Ketogenic Therapy (VLEKT) providing 600-800 kcal/day for 4 weeks. The intervention consists of meal replacements (solid or liquid, ready-to-use or reconstituted) with very low carbohydrate content, high-quality proteins (milk, whey, pea, soy), and fiber (inulin, FOS). Gluten-free, lactose-free, and vegan options are available. Meal replacements are provided by Therascience or Penta at discounted prices. Participants will self-monitor capillary ketonemia daily, maintain adequate hydration, and avoid intense physical exercise. The Advanced Hybrid Closed Loop (AHCL) insulin delivery system will be used throughout the study with periodic adjustments based on device downloads. At the end of the 4-week intervention, a structured reintroduction of conventional meals will be initiated.

Trial Locations (1)

70124

RECRUITING

University Hospital Policlinico Consorziale, Bari

All Listed Sponsors
lead

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER