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

NCT07185555 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-09-29

No results posted yet for this study

Summary

Overweight and obesity are frequent in adults with type 1 diabetes (T1D), with prevalence exceeding 50% in recent studies. Excess weight in T1D is associated with higher cardiometabolic risk and therapeutic challenges, while effective and safe weight management strategies are still limited.

This single-center, single-arm feasibility study will evaluate the efficacy and safety of a Very Low-Energy Ketogenic Therapy (VLEKT; 600-800 kcal/day) in adults with T1D and obesity treated with Advanced Hybrid Closed Loop (AHCL) insulin delivery systems. Participants will follow a structured 4-week program with commercial very-low-carbohydrate, high-protein meal replacements, under close medical supervision.

The primary endpoint is change in body weight at 4 weeks. Secondary outcomes include body composition, muscle strength, glucose metrics, insulin requirements, biochemical parameters, and patient-reported outcomes. Safety will be assessed through hypoglycemia incidence, ketone monitoring, and occurrence of diabetic ketoacidosis (DKA).

The study will enroll 14 participants. It is expected that VLEKT will achieve \~5% weight loss within one month while maintaining glycemic safety under AHCL technology.

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.

Sponsors & Collaborators

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-01-16
Primary Completion
2025-12-14
Completion
2026-03-01

Countries

  • Italy

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 NCT07185555 on ClinicalTrials.gov