Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT07185555

Vey Low-Energy Ketogenic Therapy in Adults With Type 1 Diabetes and Obesity on Intensive Insulin Therapy Using Advanded Hybrid Closed Loop System

Led by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Updated on 2025-09-29

14

Participants Needed

1

Research Sites

58 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Vey Low-Energy Ketogenic Therapy in Adults With Type 1 Diabetes and Obesity on Intensive Insulin Therapy Using Advanded Hybrid Closed Loop System

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with type 1 diabetes or autoimmune diabetes for at least 12 months
  • Body mass index (BMI) of 30 kg/m² or higher
  • HbA1c less than 9%
  • Knowledge and use of carbohydrate counting
  • Using an Advanced Hybrid Closed Loop (AHCL) insulin system for at least 3 months and willing to keep using it during the study
  • At least one diabetology follow-up visit in the past 12 months, including telemedicine
  • Willingness to purchase meal replacements for the entire study duration
Not Eligible

You will not qualify if you...

  • Ketoacidosis, severe hypoglycemia with seizures or coma, or severe hyperglycemia requiring hospitalization in the past 6 months
  • Febrile illness within the last 2 weeks
  • Dietary restrictions or intolerances incompatible with study foods
  • Celiac disease, gastroparesis, or food allergies
  • Intense physical exercise over 2 hours on more than 3 days per week
  • History or risk of eating disorders or other psychiatric disorders
  • Recreational drug use or excessive alcohol consumption
  • Chronic kidney disease with eGFR less than 60 ml/min
  • Gallstones
  • Liver failure
  • Heart failure (NYHA class III-IV), unstable angina, cardiac arrhythmia, recent heart attack, or stroke within the past 12 months
  • Respiratory failure
  • Severe or active infections
  • Planned elective surgery
  • Rare metabolic diseases such as porphyria, CPT2 deficiency, mitochondrial fatty acid oxidation defect, or pyruvate carboxylase defect
  • Current pregnancy or trying to conceive
  • Breastfeeding
  • Current glucocorticoid therapy except stable low-dose, inhaled, or replacement for adrenal insufficiency
  • Other serious medical conditions that could interfere with participation or study completion
  • Judged unable or unwilling to complete the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Policlinico Consorziale

Bari, Italy, Italy, 70124

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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