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Type 1 Diabetes (T1D)KET1DNCT07185555

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

A study testing VLEKT in people with Type 1 Diabetes (T1D) and Obesity (Disorder), run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Type 1 Diabetes (T1D), Obesity (Disorder)
What is being tested?
VLEKT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteItaly
Study dates
16 Jan 2025to 1 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting

  • University Hospital Policlinico Consorziale

    Bari, Italy, 70124

    Lucia Coriolano, +393426275748, luciacoriolano@outlook.com

    Francesco Giorgino, M.D., Ph.D.

    Recruiting

Other trials in Italy

About this study

Official title: 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

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.

Read more

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.

Read the 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-energy foods to prevent hypoglycemia, reduced physical activity due to fear of hypoglycemia, and pathophysiological mechanisms such as adipose tissue dysfunction and insulin resistance. Current therapeutic options for weight management in T1D are limited compared with type 2 diabetes, and novel approaches are urgently needed.

Ketogenic and very low-carbohydrate diets are effective in obesity and type 2 diabetes but have traditionally been discouraged in T1D because of risks of hypoglycemia, dyslipidemia, poor adherence, and diabetic ketoacidosis (DKA). The introduction of Advanced Hybrid Closed Loop (AHCL) systems, which combine continuous glucose monitoring with automated insulin delivery, provides a safer framework to test structured dietary interventions that were previously considered unsuitable in this population.

This feasibility study investigates a Very Low-Energy Ketogenic Therapy (VLEKT) for 4 weeks in adults with T1D and obesity using AHCL technology. The intervention will consist of commercially available meal replacements (600-800 kcal/day, <30 g/day carbohydrates, adequate protein supply) with strict monitoring of capillary ketones and insulin adjustments.

Baseline assessments include anthropometry, bioimpedance-derived body composition, handgrip strength, biochemical testing, continuous glucose monitoring metrics, and validated questionnaires (SF-12, IPAQ, PSQI, FH-15). Participants will attend weekly visits for clinical review, adherence reinforcement, safety checks, and repeat assessments. At study completion, a gradual reintroduction of conventional meals will be initiated.

The primary endpoint is absolute weight change after 4 weeks. Secondary endpoints include proportion achieving ≥5% weight loss, changes in body composition and muscle strength, glucose control (TIR, TAR, TBR, CV, GMI, GRI, TITR), insulin requirements, lipid and liver function markers, and patient-reported outcomes. Safety evaluation will focus on hypoglycemia incidence and DKA events.

Sample size calculation determined that 14 participants are required to detect a clinically relevant mean weight reduction of ~5%. The results will provide initial evidence on the feasibility, metabolic impact, and safety of VLEKT in this specific population, laying the groundwork for larger randomized controlled trials.

Being tested
VLEKT
Keywords
Type 1 Diabetes Mellitus, Obesity, Very Low-Energy Ketogenic Diet, Insulin Therapy, Weight Loss, Continuous Glucose Monitoring, Advanced Hybrid Closed Loop
Medical subject headings
Diabetes Mellitus, Type 1, Obesity, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VLEKTDietary supplement

    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.

Study groups in NCT07185555
Study groupRoleWhat they receive
Very Low-Energy Ketogenic Therapy with Advanced Hybrid Closed Loop in Adults with T1D and ObesityExperimentalParticipants will undergo a 4-week Very Low-Energy Ketogenic Therapy (600-800 kcal/day) using commercial meal replacements with very low carbohydrate content, high biological value proteins (milk, whey, pea, soy), and added fiber (inulin, FOS). Gluten-free, lactose-free, and vegan options will be available. Therapy will be performed while continuing intensive insulin treatment with an Advanced Hybrid Closed Loop (AHCL) system. Participants will perform daily self-monitoring of capillary ketonemia, maintain hydration, and abstain from intense exercise. Follow-up visits at weeks 1, 2, 3, and 4 will assess safety, metabolic control, and weight loss. After completion, a structured reintroduction of conventional meals will be initiated.
Receives: Dietary Supplement: VLEKT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight from baseline to end of 4-week Very Low-Energy Ketogenic Therapy

    Body weight will be measured in kilograms using a calibrated scale at baseline and after completion of the 4-week intervention. The primary outcome is the absolute change in weight from baseline. Participants will be assessed under standardized conditions (light clothing, no shoes, fasting state where possible).

    Measured: Baseline and Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2025
  2. Study start16 Jan 2025
  3. Primary completion14 Dec 2025 (estimated)
  4. Study completion1 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07185555
Sponsor's protocol ID
1835/CEL
Acronym
KET1D
Status last verified
Sep 2025
First submitted
15 Sep 2025
Last updated
29 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Barrea L, Caprio M, Grassi D, Cicero AFG, Bagnato C, Paolini B, Muscogiuri G. A New Nomenclature for the Very Low-Calorie Ketogenic Diet (VLCKD): Very Low-Energy Ketogenic Therapy (VLEKT). Ketodiets and Nutraceuticals Expert Panels: "KetoNut", Italian Society of Nutraceuticals (SINut) and the Italian Association of Dietetics and Clinical Nutrition (ADI). Curr Nutr Rep. 2024 Sep;13(3):552-556. doi: 10.1007/s13668-024-00560-w. Epub 2024 Jul 23.

    PubMed 39039372

  • Phillip M, Nimri R, Bergenstal RM, Barnard-Kelly K, Danne T, Hovorka R, Kovatchev BP, Messer LH, Parkin CG, Ambler-Osborn L, Amiel SA, Bally L, Beck RW, Biester S, Biester T, Blanchette JE, Bosi E, Boughton CK, Breton MD, Brown SA, Buckingham BA, Cai A, Carlson AL, Castle JR, Choudhary P, Close KL, Cobelli C, Criego AB, Davis E, de Beaufort C, de Bock MI, DeSalvo DJ, DeVries JH, Dovc K, Doyle FJ, Ekhlaspour L, Shvalb NF, Forlenza GP, Gallen G, Garg SK, Gershenoff DC, Gonder-Frederick LA, Haidar A, Hartnell S, Heinemann L, Heller S, Hirsch IB, Hood KK, Isaacs D, Klonoff DC, Kordonouri O, Kowalski A, Laffel L, Lawton J, Lal RA, Leelarathna L, Maahs DM, Murphy HR, Norgaard K, O'Neal D, Oser S, Oser T, Renard E, Riddell MC, Rodbard D, Russell SJ, Schatz DA, Shah VN, Sherr JL, Simonson GD, Wadwa RP, Ward C, Weinzimer SA, Wilmot EG, Battelino T. Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice. Endocr Rev. 2023 Mar 4;44(2):254-280. doi: 10.1210/endrev/bnac022.

    PubMed 36066457

  • Guerci B, Sauvanet JP. Subcutaneous insulin: pharmacokinetic variability and glycemic variability. Diabetes Metab. 2005 Sep;31(4 Pt 2):4S7-4S24. doi: 10.1016/s1262-3636(05)88263-1.

    PubMed 16389894

  • McAuley SA, Horsburgh JC, Ward GM, La Gerche A, Gooley JL, Jenkins AJ, MacIsaac RJ, O'Neal DN. Insulin pump basal adjustment for exercise in type 1 diabetes: a randomised crossover study. Diabetologia. 2016 Aug;59(8):1636-44. doi: 10.1007/s00125-016-3981-9. Epub 2016 May 11.

    PubMed 27168135

  • Paldus B, Morrison D, Zaharieva DP, Lee MH, Jones H, Obeyesekere V, Lu J, Vogrin S, La Gerche A, McAuley SA, MacIsaac RJ, Jenkins AJ, Ward GM, Colman P, Smart CEM, Seckold R, King BR, Riddell MC, O'Neal DN. A Randomized Crossover Trial Comparing Glucose Control During Moderate-Intensity, High-Intensity, and Resistance Exercise With Hybrid Closed-Loop Insulin Delivery While Profiling Potential Additional Signals in Adults With Type 1 Diabetes. Diabetes Care. 2022 Jan 1;45(1):194-203. doi: 10.2337/dc21-1593.

    PubMed 34789504

  • Mallad A, Hinshaw L, Schiavon M, Dalla Man C, Dadlani V, Basu R, Lingineni R, Cobelli C, Johnson ML, Carter R, Kudva YC, Basu A. Exercise effects on postprandial glucose metabolism in type 1 diabetes: a triple-tracer approach. Am J Physiol Endocrinol Metab. 2015 Jun 15;308(12):E1106-15. doi: 10.1152/ajpendo.00014.2015. Epub 2015 Apr 21.

    PubMed 25898950

  • Buehler LA, Noe D, Knapp S, Isaacs D, Pantalone KM. Ketogenic diets in the management of type 1 diabetes: Safe or safety concern? Cleve Clin J Med. 2021 Oct 1;88(10):547-555. doi: 10.3949/ccjm.88a.20121.

    PubMed 34598919

  • Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Research Group; Nathan DM, Zinman B, Cleary PA, Backlund JY, Genuth S, Miller R, Orchard TJ. Modern-day clinical course of type 1 diabetes mellitus after 30 years' duration: the diabetes control and complications trial/epidemiology of diabetes interventions and complications and Pittsburgh epidemiology of diabetes complications experience (1983-2005). Arch Intern Med. 2009 Jul 27;169(14):1307-16. doi: 10.1001/archinternmed.2009.193.

    PubMed 19636033

  • Weight gain associated with intensive therapy in the diabetes control and complications trial. The DCCT Research Group. Diabetes Care. 1988 Jul-Aug;11(7):567-73. doi: 10.2337/diacare.11.7.567.

    PubMed 2904881

  • Russo G, De Cosmo S, Di Bartolo P, Lucisano G, Manicardi V, Nicolucci A, Rocca A, Rossi MC, Di Cianni G, Candido R; AMD Annals Study Group. The quality of care in type 1 and type 2 diabetes - A 2023 update of the AMD Annals initiative. Diabetes Res Clin Pract. 2024 Jul;213:111743. doi: 10.1016/j.diabres.2024.111743. Epub 2024 Jun 13.

    PubMed 38878867

  • Musil F, Smahelova A, Blaha V, Hyspler R, Ticha A, Lesna J, Zadak Z, Sobotka L. Effect of low calorie diet and controlled fasting on insulin sensitivity and glucose metabolism in obese patients with type 1 diabetes mellitus. Physiol Res. 2013;62(3):267-76. doi: 10.33549/physiolres.932381. Epub 2013 Mar 14.

    PubMed 23489182

  • Barrea L, Caprio M, Camajani E, Verde L, Perrini S, Cignarelli A, Prodam F, Gambineri A, Isidori AM, Colao A, Giorgino F, Aimaretti G, Muscogiuri G. Ketogenic nutritional therapy (KeNuT)-a multi-step dietary model with meal replacements for the management of obesity and its related metabolic disorders: a consensus statement from the working group of the Club of the Italian Society of Endocrinology (SIE)-diet therapies in endocrinology and metabolism. J Endocrinol Invest. 2024 Mar;47(3):487-500. doi: 10.1007/s40618-023-02258-2. Epub 2024 Jan 18.

    PubMed 38238506

  • Gardemann C, Knowles S, Marquardt T. Managing type 1 diabetes mellitus with a ketogenic diet. Endocrinol Diabetes Metab Case Rep. 2023 Aug 16;2023(3):23-0008. doi: 10.1530/EDM-23-0008. Print 2023 Aug 1.

    PubMed 37584373

  • Corbin KD, Driscoll KA, Pratley RE, Smith SR, Maahs DM, Mayer-Davis EJ; Advancing Care for Type 1 Diabetes and Obesity Network (ACT1ON). Obesity in Type 1 Diabetes: Pathophysiology, Clinical Impact, and Mechanisms. Endocr Rev. 2018 Oct 1;39(5):629-663. doi: 10.1210/er.2017-00191.

    PubMed 30060120

  • Fang M, Jeon Y, Echouffo-Tcheugui JB, Selvin E. Prevalence and Management of Obesity in U.S. Adults With Type 1 Diabetes. Ann Intern Med. 2023 Mar;176(3):427-429. doi: 10.7326/M22-3078. Epub 2023 Feb 14. No abstract available.

    PubMed 36780652

Questions about this trial

What is this clinical trial studying?

A study testing VLEKT in people with Type 1 Diabetes (T1D) and Obesity (Disorder), run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight from baseline to end of 4-week Very Low-Energy Ketogenic Therapy (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07185555, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.

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