Vey Low-Energy Ketogenic Therapy in Adults With Type 1 Diabetes and Obesity on Intensive Insulin Therapy Using Advanded Hybrid Closed Loop System
Recruiting · NCT07185555 · Interventional (participants receive a specific treatment) · Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
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)
- ther 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
Where it is running
1 location listed.
- University Hospital Policlinico Consorziale - Bari, Italy, Italy