NCT07185555 Vey Low-Energy Ketogenic Therapy in Adults With Type 1 Diabetes and Obesity on Intensive Insulin Therapy Using Advanded Hybrid Closed Loop System

Eligibility & Interventions

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This trial targets 14 participants in total. It began in 2025-01-16 with a primary completion date of 2025-12-14.

Brief 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.

Eligibility Criteria

Inclusion Criteria: 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 Criteria: Ketoacidosis, severe hypoglycemia with seizures/coma, or severe hyperglycemia requiring hospitalization in the last 6 months Febrile illness within the last 2 weeks Dietary restrictions or intolerances incompatible with study food supplies Celiac disease, gastroparesis, food allergies Intense physical exercise \>2 hours on \>3 days per week History or risk of eating disorder, or other psychiatric disorders Recreational drug use or excessive alcohol consumption Chronic kidney disease (eGFR \<60 ml/min) Gallstones 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 Planned elective surgery Rare metabolic diseases (porphyria, CPT2 deficiency, mitochondrial fatty acid oxidation defect, pyruvate carboxylase defect) Pregnancy (current or actively trying to conceive) Breastfeeding 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 Participant judged unable or unwilling to complete the study

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