NCT07185555Recruiting
Vey Low-Energy Ketogenic Therapy in Adults With Type 1 Diabetes and Obesity on Intensive Insulin Therapy Using Advanded Hybrid Closed Loop System
Applying Very Low Calorie Ketogenic Diet to the Treatment of Obesity in People With Type 1 Diabetes on Intensive Insulin Therapy Using Automated Insulin Delivery System
Source: ClinicalTrials.gov · Last updated 29 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 16 Jan 2025
- Primary completion date
- 14 Dec 2025
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Diseases
- Obesity, Type 1 diabetes
- NCT number
- NCT07185555
What you commit to
- Study type: Interventional
- Planned participants: 14
- From 16 Jan 2025 to the primary completion date, 14 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recreational drug use or excessive alcohol consumption
- Planned elective surgery
Other illness
- Ketoacidosis, severe hypoglycemia with seizures/coma, or severe hyperglycemia requiring hospitalization in the last 6 months
- Febrile illness within the last 2 weeks
- Celiac disease, gastroparesis, food allergies
- History or risk of eating disorder, or other psychiatric disorders
- 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
- Rare metabolic diseases (porphyria, CPT2 deficiency, mitochondrial fatty acid oxidation defect, pyruvate carboxylase defect)
- 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
Lab values
- Chronic kidney disease (eGFR \<60 ml/min)
Other
- Dietary restrictions or intolerances incompatible with study food supplies
- Intense physical exercise \>2 hours on \>3 days per week
- Gallstones
- Pregnancy (current or actively trying to conceive)
- Breastfeeding
- Participant judged unable or unwilling to complete the study
Who the study is looking for
- 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
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Policlinico Consorziale Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.