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New treatment option for Type 1 Diabetes (T1D)
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
ClinicalTrials.gov ID: NCT07185555
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join 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
You likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bari, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bari, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.