Status:
RECRUITING
Vey Low-Energy Ketogenic Therapy in Adults With Type 1 Diabetes and Obesity on Intensive Insulin Therapy Using Advanded Hybrid Closed Loop System
Lead Sponsor:
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Conditions:
Type 1 Diabetes (T1D)
Obesity (Disorder)
Eligibility:
All Genders
18-99 years
Phase:
NA
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 thera...
Detailed Description
Excess weight in type 1 diabetes (T1D) is increasingly recognized as a critical clinical problem. Factors contributing to weight gain include intensive insulin therapy, compensatory intake of high-ene...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
January 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT07185555
Start Date
January 16 2025
End Date
March 1 2026
Last Update
September 29 2025
Active Locations (1)
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1
University Hospital Policlinico Consorziale
Bari, Italy, Italy, 70124