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

Conditions studied: Type 1 Diabetes (T1D), Obesity (Disorder)

In brief

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.

Key facts

Study ID

NCT07185555

Run by

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

People needed

14

Starts

2025-01-16

Expected to finish

2026-03-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospital Policlinico Consorziale — Bari, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

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