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

Trial details

Who runs it

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Trial code

NCT07185555

Record updated

29 September 2025

Original description

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.Read full original descriptionShow less

Applying Very Low Calorie Ketogenic Diet to the Treatment of Obesity in People With Type 1 Diabetes on Intensive Insulin Therapy Using Automated Insulin Delivery System

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.

Inclusion: Age ≥ 18 years; Diagnosis of type 1 diabetes or autoimmune diabetes for ≥ 12 months; BMI ≥ 30 kg/m²; HbA1c < 9%; Knowledge and use of carbohydrate counting; Use of an Advanced Hybrid Closed Loop (AHCL) system for ≥ 3 months and willingness to maintain it during the study; At least 1 diabetology follow-up visit in the last 12 months (including telemedicine); Willingness to purchase meal replacements for the entire study duration.

Exclusion: Recreational drug use or excessive alcohol consumption; Planned elective surgery; Ketoacidosis, severe hypoglycemia with seizures/coma, or severe hyperglycemia requiring hospitalization in the last 6 months; Febrile illness within the last 2 weeks; Celiac disease, gastroparesis, food allergies; History or risk of eating disorder, or other psychiatric disorders; Liver failure; Heart failure (NYHA III-IV), unstable angina, cardiac arrhythmia, myocardial infarction, or stroke within the last 12 months; Respiratory failure; Severe or active infections; Rare metabolic diseases (porphyria, CPT2 deficiency, mitochondrial fatty acid oxidation defect, pyruvate carboxylase defect); Current glucocorticoid therapy (except stable low-dose, inhaled, or replacement for adrenal insufficiency); Other serious medical conditions that might interfere with participation or study completion in the investigator's judgment; Chronic kidney disease (eGFR <60 ml/min); Dietary restrictions or intolerances incompatible with study food supplies; Intense physical exercise >2 hours on >3 days per week; Gallstones; Pregnancy (current or actively trying to conceive); Breastfeeding; Participant judged unable or unwilling to complete the study.

ClinicalTrials.gov NCT07185555