RecruitingNot ApplicableNCT07185555

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

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Enrollment

14 participants

Start Date

Jan 16, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity (Disorder)Type 1 Diabetes (T1D)

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 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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria8

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 Criteria20

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

Interventions

DIETARY_SUPPLEMENTVLEKT

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.