Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07185555

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionType 1 Diabetes (T1D), Obesity (Disorder)

Full registry 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

Treatments and study arms

VLEKT

Dietary Supplement

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.

Primary outcomes

Change in body weight from baseline to end of 4-week Very Low-Energy Ketogenic TherapyBaseline and Week 4

Body weight will be measured in kilograms using a calibrated scale at baseline and after completion of the 4-week intervention. The primary outcome is the absolute change in weight from baseline. Participants will be assessed under standardized conditions (light clothing, no shoes, fasting state where possible).

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University Hospital Policlinico Consorziale🇮🇹 Bari, Italy, Italy
Lucia CoriolanoContact
Francesco Giorgino, M.D., Ph.D.Principal Investigator
Angelo Cignarelli, M.D., Ph.D.Sub Investigator