Diabetes Mellitus, Type 2KETO-MINCT05275608
Effects of VLCKD in Metabolic Syndrome
A study testing VLCKD diet with replacing meals and Hypocaloric mediterranean Diet in people with Diabetes Mellitus, Type 2 and Non-alcoholic Fatty Liver Disease, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
VLCKD has showed to be an impactful diet on several metabolism aspects and has proven to be useful for preventing and treating diabetes mellitus type 2, overweight, chronic inflammation and fatty liver. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- VLCKD diet with replacing meals and Hypocaloric mediterranean Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2022to Dec 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 25-65
- BMI 30-40 mg/m2
- NAFLD
- DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, basal insulin) and HbA1c > 7 and < 10 %.
Who cannot join
- Secondary obesity due to genetic or endocrinologic causes.
- renal disease with eGFR < 45 mL/min/1.73m2 or macroalbuminuria or calculosis
- insulin basal + bolus or HbA1c% >10.0%
- Other types of DM
- ipopituitarism or adrenal insufficiency
- antibiotics use less than 3 months before the first visit
Trial locations and contacts
1 site in 1 country.
Italy1 site
: Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont
Novara, Italy, 28100
About this study
Official title: Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients With Metabolic Syndrome
VLCKD has showed to be an impactful diet on several metabolism aspects and has proven to be useful for preventing and treating diabetes mellitus type 2, overweight, chronic inflammation and fatty liver.
For this reason, the aim of this pilot study is to examinate the potential effect of a VLCKD on a group of patients that contemporarily have DM2, obesity and Non alcholic fatty liver disease (NAFLD), comparing the results with an ipocaloric diet based on Mediterranean Principles and Italian LARN (SINU 2014).
Read more
This study will consider several interrelated outcomes such as anthropometric data, hematochemical and hormonal parameters, questionnaires, stool microbiota and omics, blood microvescicles, urine tests, instrumental tests (DXA, BIVA, ecographies), biopses and functional tests.
40 subjects will be evaluated and divided in two groups of 20 (VLCKD) and 20 (MedDiet).
- Being tested
- VLCKD diet with replacing meals, Hypocaloric mediterranean Diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLCKD diet with replacing mealsDietary supplement
Patients will receive an accurate teaching + brochure on VLCKD diet from an expert dietician and freely receive the correct amount of supplements provided from Labotaoire Therascience (4 or 5 meals). The supplements contain (in total) between 600 and 800 kcal, mainly fats, 1,2/1,5 g/body weight of proteins, very low amount of charbohydrates (<30/40g/die), 10-20g fibers, + minerals and vitamins covering the needings of patients. After 6-8 weeks, 1 meal will be replaced with a natural dish rich in proteins.
Hypocaloric mediterranean DietBehavioural
Patients will receive an accurate teaching + brochure on an hypocaloric Mediterranean style diet (LARN 2014) from an expert dietician. Patients will follow the istructions on grams and foods to eat. The calories will be around minus 400-500 kcal from energy requirement (measured by indirect calorimetry * physical activity score).
| Study group | Role | What they receive |
|---|---|---|
| VLCKD | Experimental | 20 Patients recruited from our endocrinology department that will keep the same medical visits frequency and drugs and accept to be randomized to one of the two groups.
Inclusion criteria:
* Age 25-65
* BMI 30-40 mg/m2
* NAFLD
* DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, insulin) and HbA1c > 7 and < 10 %. Receives: Dietary Supplement: VLCKD diet with replacing meals |
| Hypocaloric Mediterranean Diet | Active comparator | 20 Patients recruited from our endocrinology department that will keep the same medical visits frequency and drugs and accept to be randomized to one of the two groups.
Inclusion criteria:
* Age 25-65
* BMI 30-40 mg/m2
* NAFLD
* DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, insulin) and HbA1c > 7 and < 10 %. Receives: Behavioral: Hypocaloric mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight
Variation of body weight assessed through body mass index change (BMI)(kg/m2)
Measured: Change from Baseline BMI at 15 days, 30 days, 60 days, 90 days
Change in body circumferences
Variation of body circumferences (waist, hips)
Measured: Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days
Change in metabolic control
Variation of blood glucose
Measured: Change from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days
Change in metabolic control
Change of cardio-metabolic risk factors: lipid profile
Measured: Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days
Secondary outcomes (30)
Change in Metabolic control
Change of cardio-metabolic risk factors: insulin resistance (HOMA-IR)
Measured: Change from Baseline HOMA-IR at 15 days, 30 days, 60 days, 90 days
Change in kidney profile
Variation of serum creatinin
Measured: Change from Baseline Serum Creatinin at 15 days, 30 days, 60 days, 90 days
Change in liver profile
Variation of liver profile (AST, ALT, GGT, bilirubin)
Measured: Change from Baseline liver profile at 15 days, 30 days, 60 days, 90 days
Change in uric acid
Variation of uric acid in blood
Measured: Change from Baseline uric acid at 15 days, 30 days, 60 days, 90 days
Change in blood pressure
Variation of blood pressure (diastolic and sistolic)
Measured: Change from Baseline blood pressure at 15 days, 30 days, 60 days, 90 days
Change in body composition
Change of body composition (fat mass %) (BIVA)
Measured: Change from Baseline fat mass% at 15 days, 30 days, 60 days, 90 days
Change in body composition
Change of body composition (fat mass %) (DXA)
Measured: Change from Baseline fat mass% at 90 days
Change in muscolar functionality
Changes observed from functional tests (handgrip strenght)
Measured: Change from Baseline scores at 30, 90 days
Change in muscolar functionality
Changes observed from functional tests (short physical portable battery score)
Measured: Change from Baseline scores at 30, 90 days
Change in muscolar functionality
Changes observed from functional tests (time up and go test)
Measured: Change from Baseline scores at 30, 90 days
Change in hormones
Variation of hormones in blood (ghrelin, leptin, adiponectin)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (irisin)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (zonulin)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (asprosin)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (TSH)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (FT4)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (PTH)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (25OH vitamin D)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (PYY)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Variation of hormones in blood (IGF-1)
Measured: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in blood ketones
Variation of ketones in blood
Measured: Change from Baseline blood ketones at 15, 30 days, 60 days, 90 days
Change in basal metabolic rate
Variation of basal metabolic rate through indirect calorimetry
Measured: Change from Baseline basal metabolic rate at 90 days
Change in urine ketones
Variation of urine excretion in terms of ketones
Measured: Change from Baseline urine ketones at 15, 30 days, 60 days, 90 days
Change in urine nitrogen excretion
Variation of urine excretion in terms of nitrogen
Measured: Change from Baseline urine nitrogen at 15, 30 days, 60 days, 90 days
Change in omics profile
Variation of metabolomic profile of stools through liquid and gas chromatography
Measured: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Change in omics profile
Variation of lipidomic profile of stools through liquid and gas chromatography
Measured: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Change in omics profile
Variation of proteomic profile of stools through liquid and gas chromatography
Measured: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Change in microbiota
Variation of prevalence of microbiota phyla through DNA sequencing of stools
Measured: Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 60 days, 90 days
Change in inflammatory status
Variation of inflammatory status in blood (C-reactive protein CRP)
Measured: Change from Baseline CRP and cytokines at 15, 30 days, 60 days, 90 days
Change in inflammatory status
Variation of inflammatory status in blood (cytokines count)
Measured: Change from Baseline cytokines at 15, 30 days, 60 days, 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study start7 Nov 2022
- Primary completion31 Jan 2026
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire THERASCIENCE
- Responsible party
- Principal investigator, Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275608
- Sponsor's protocol ID
- CE 296/21
- Acronym
- KETO-MI
- Status last verified
- Jul 2026
- First submitted
- 21 Feb 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abbasi J. Interest in the Ketogenic Diet Grows for Weight Loss and Type 2 Diabetes. JAMA. 2018 Jan 16;319(3):215-217. doi: 10.1001/jama.2017.20639. No abstract available.
PubMed 29340675American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S46-S60. doi: 10.2337/dc19-S005.
PubMed 30559231American Diabetes Association. 8. Obesity Management for the Treatment of Type 2 Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S81-S89. doi: 10.2337/dc19-S008.
PubMed 30559234Ang QY, Alexander M, Newman JC, Tian Y, Cai J, Upadhyay V, Turnbaugh JA, Verdin E, Hall KD, Leibel RL, Ravussin E, Rosenbaum M, Patterson AD, Turnbaugh PJ. Ketogenic Diets Alter the Gut Microbiome Resulting in Decreased Intestinal Th17 Cells. Cell. 2020 Jun 11;181(6):1263-1275.e16. doi: 10.1016/j.cell.2020.04.027. Epub 2020 May 20.
PubMed 32437658Very low-calorie diets. National Task Force on the Prevention and Treatment of Obesity, National Institutes of Health. JAMA. 1993 Aug 25;270(8):967-74.
PubMed 8345648ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Baker ST, Jerums G, Prendergast LA, Panagiotopoulos S, Strauss BJ, Proietto J. Less fat reduction per unit weight loss in type 2 diabetic compared with nondiabetic obese individuals completing a very-low-calorie diet program. Metabolism. 2012 Jun;61(6):873-82. doi: 10.1016/j.metabol.2011.10.017. Epub 2011 Dec 5.
PubMed 22146094Barengolts E. GUT MICROBIOTA, PREBIOTICS, PROBIOTICS, AND SYNBIOTICS IN MANAGEMENT OF OBESITY AND PREDIABETES: REVIEW OF RANDOMIZED CONTROLLED TRIALS. Endocr Pract. 2016 Oct;22(10):1224-1234. doi: 10.4158/EP151157.RA. Epub 2016 Jul 13.
PubMed 27409822Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1.
PubMed 31263284Cabrera-Mulero A, Tinahones A, Bandera B, Moreno-Indias I, Macias-Gonzalez M, Tinahones FJ. Keto microbiota: A powerful contributor to host disease recovery. Rev Endocr Metab Disord. 2019 Dec;20(4):415-425. doi: 10.1007/s11154-019-09518-8.
PubMed 31720986Cappellano G, Morandi EM, Rainer J, Grubwieser P, Heinz K, Wolfram D, Bernhard D, Lobenwein S, Pierer G, Ploner C. Human Macrophages Preferentially Infiltrate the Superficial Adipose Tissue. Int J Mol Sci. 2018 May 8;19(5):1404. doi: 10.3390/ijms19051404.
PubMed 29738484Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.
PubMed 31111407Capstick F, Brooks BA, Burns CM, Zilkens RR, Steinbeck KS, Yue DK. Very low calorie diet (VLCD): a useful alternative in the treatment of the obese NIDDM patient. Diabetes Res Clin Pract. 1997 May;36(2):105-11. doi: 10.1016/s0168-8227(97)00038-7.
PubMed 9229194Caresio C, Salvi M, Molinari F, Meiburger KM, Minetto MA. Fully Automated Muscle Ultrasound Analysis (MUSA): Robust and Accurate Muscle Thickness Measurement. Ultrasound Med Biol. 2017 Jan;43(1):195-205. doi: 10.1016/j.ultrasmedbio.2016.08.032. Epub 2016 Oct 6.
PubMed 27720522Cicero AF, Benelli M, Brancaleoni M, Dainelli G, Merlini D, Negri R. Middle and Long-Term Impact of a Very Low-Carbohydrate Ketogenic Diet on Cardiometabolic Factors: A Multi-Center, Cross-Sectional, Clinical Study. High Blood Press Cardiovasc Prev. 2015 Dec;22(4):389-94. doi: 10.1007/s40292-015-0096-1. Epub 2015 May 19.
PubMed 25986079
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT05275608
- Acronym / sponsor ID
- KETO-MI / CE 296/21
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Collaborators
- Laboratoire THERASCIENCE
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VLCKD has showed to be an impactful diet on several metabolism aspects and has proven to be useful for preventing and treating diabetes mellitus type 2, overweight, chronic inflammation and fatty liver.
For this reason, the aim of this pilot study is to examinate the potential effect of a VLCKD on a group of patients that contemporarily have DM2, obesity and Non alcholic fatty liver disease (NAFLD), comparing the results with an ipocaloric diet based on Mediterranean Principles and Italian LARN (SINU 2014).
This study will consider several interrelated outcomes such as anthropometric data, hematochemical and hormonal parameters, questionnaires, stool microbiota and omics, blood microvescicles, urine tests, instrumental tests (DXA, BIVA, ecographies), biopses and functional tests.
40 subjects will be evaluated and divided in two groups of 20 (VLCKD) and 20 (MedDiet).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VLCKD | Experimental | Dietary Supplement: VLCKD diet with replacing meals20 Patients recruited from our endocrinology department that will keep the same medical visits frequency and drugs and accept to be randomized to one of the two groups. Inclusion criteria: * Age 25-65 * BMI 30-40 mg/m2 * NAFLD * DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, insulin) and HbA1c > 7 and < 10 %. |
| Hypocaloric Mediterranean Diet | Active comparator | Behavioral: Hypocaloric mediterranean Diet20 Patients recruited from our endocrinology department that will keep the same medical visits frequency and drugs and accept to be randomized to one of the two groups. Inclusion criteria: * Age 25-65 * BMI 30-40 mg/m2 * NAFLD * DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, insulin) and HbA1c > 7 and < 10 %. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 25-65
- BMI 30-40 mg/m2
- NAFLD
- DM2 drug-treated (metformin, SGLT2 inhibitors, GLP-1 analogues, DPPIV inhibitors, basal insulin) and HbA1c > 7 and < 10 %.
Key exclusion criteria (6 listed)
- Secondary obesity due to genetic or endocrinologic causes.
- renal disease with eGFR < 45 mL/min/1.73m2 or macroalbuminuria or calculosis
- insulin basal + bolus or HbA1c% >10.0%
- Other types of DM
- ipopituitarism or adrenal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLCKD diet with replacing mealsPatients will receive an accurate teaching + brochure on VLCKD diet from an expert dietician and freely receive the correct amount of supplements provided from Labotaoire Therascience (4 or 5 meals). The supplements contain (in total) between 600 and 800 kcal, mainly fats, 1,2/1,5 g/body weight of proteins, very low amount of charbohydrates (<30/40g/die), 10-20g fibers, + minerals and vitamins covering the needings of patients. After 6-8 weeks, 1 meal will be replaced with a natural dish rich in proteins. | Dietary supplement | VLCKD |
| Hypocaloric mediterranean DietPatients will receive an accurate teaching + brochure on an hypocaloric Mediterranean style diet (LARN 2014) from an expert dietician. Patients will follow the istructions on grams and foods to eat. The calories will be around minus 400-500 kcal from energy requirement (measured by indirect calorimetry * physical activity score). | Behavioural | Hypocaloric Mediterranean Diet |
Primary outcome
Change in weight
Time frame: Change from Baseline BMI at 15 days, 30 days, 60 days, 90 days
Variation of body weight assessed through body mass index change (BMI)(kg/m2)
Change in body circumferences
Time frame: Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days
Variation of body circumferences (waist, hips)
Change in metabolic control
Time frame: Change from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days
Variation of blood glucose
Change in metabolic control
Time frame: Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days
Change of cardio-metabolic risk factors: lipid profile
30 secondary outcomes
Change in Metabolic control
Time frame: Change from Baseline HOMA-IR at 15 days, 30 days, 60 days, 90 days
Change in kidney profile
Time frame: Change from Baseline Serum Creatinin at 15 days, 30 days, 60 days, 90 days
Change in liver profile
Time frame: Change from Baseline liver profile at 15 days, 30 days, 60 days, 90 days
Change in uric acid
Time frame: Change from Baseline uric acid at 15 days, 30 days, 60 days, 90 days
Change in blood pressure
Time frame: Change from Baseline blood pressure at 15 days, 30 days, 60 days, 90 days
Change in body composition
Time frame: Change from Baseline fat mass% at 15 days, 30 days, 60 days, 90 days
Change in body composition
Time frame: Change from Baseline fat mass% at 90 days
Change in muscolar functionality
Time frame: Change from Baseline scores at 30, 90 days
Change in muscolar functionality
Time frame: Change from Baseline scores at 30, 90 days
Change in muscolar functionality
Time frame: Change from Baseline scores at 30, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in hormones
Time frame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
Change in blood ketones
Time frame: Change from Baseline blood ketones at 15, 30 days, 60 days, 90 days
Change in basal metabolic rate
Time frame: Change from Baseline basal metabolic rate at 90 days
Change in urine ketones
Time frame: Change from Baseline urine ketones at 15, 30 days, 60 days, 90 days
Change in urine nitrogen excretion
Time frame: Change from Baseline urine nitrogen at 15, 30 days, 60 days, 90 days
Change in omics profile
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Change in omics profile
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Change in omics profile
Time frame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
Change in microbiota
Time frame: Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 60 days, 90 days
Change in inflammatory status
Time frame: Change from Baseline CRP and cytokines at 15, 30 days, 60 days, 90 days
Change in inflammatory status
Time frame: Change from Baseline cytokines at 15, 30 days, 60 days, 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 29340675Abbasi J. Interest in the Ketogenic Diet Grows for Weight Loss and Type 2 Diabetes. JAMA. 2018 Jan 16;319(3):215-217. doi: 10.1001/jama.2017.20639. No abstract available.
- Background: PubMed 30559231American Diabetes Association. 5. Lifestyle Management: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S46-S60. doi: 10.2337/dc19-S005.
- Background: PubMed 30559234American Diabetes Association. 8. Obesity Management for the Treatment of Type 2 Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S81-S89. doi: 10.2337/dc19-S008.
- Background: PubMed 32437658Ang QY, Alexander M, Newman JC, Tian Y, Cai J, Upadhyay V, Turnbaugh JA, Verdin E, Hall KD, Leibel RL, Ravussin E, Rosenbaum M, Patterson AD, Turnbaugh PJ. Ketogenic Diets Alter the Gut Microbiome Resulting in Decreased Intestinal Th17 Cells. Cell. 2020 Jun 11;181(6):1263-1275.e16. doi: 10.1016/j.cell.2020.04.027. Epub 2020 May 20.
- Background: PubMed 8345648Very low-calorie diets. National Task Force on the Prevention and Treatment of Obesity, National Institutes of Health. JAMA. 1993 Aug 25;270(8):967-74.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 22146094Baker ST, Jerums G, Prendergast LA, Panagiotopoulos S, Strauss BJ, Proietto J. Less fat reduction per unit weight loss in type 2 diabetic compared with nondiabetic obese individuals completing a very-low-calorie diet program. Metabolism. 2012 Jun;61(6):873-82. doi: 10.1016/j.metabol.2011.10.017. Epub 2011 Dec 5.
- Background: PubMed 27409822Barengolts E. GUT MICROBIOTA, PREBIOTICS, PROBIOTICS, AND SYNBIOTICS IN MANAGEMENT OF OBESITY AND PREDIABETES: REVIEW OF RANDOMIZED CONTROLLED TRIALS. Endocr Pract. 2016 Oct;22(10):1224-1234. doi: 10.4158/EP151157.RA. Epub 2016 Jul 13.
- Background: PubMed 31263284Depommier C, Everard A, Druart C, Plovier H, Van Hul M, Vieira-Silva S, Falony G, Raes J, Maiter D, Delzenne NM, de Barsy M, Loumaye A, Hermans MP, Thissen JP, de Vos WM, Cani PD. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019 Jul;25(7):1096-1103. doi: 10.1038/s41591-019-0495-2. Epub 2019 Jul 1.
- Background: PubMed 31720986Cabrera-Mulero A, Tinahones A, Bandera B, Moreno-Indias I, Macias-Gonzalez M, Tinahones FJ. Keto microbiota: A powerful contributor to host disease recovery. Rev Endocr Metab Disord. 2019 Dec;20(4):415-425. doi: 10.1007/s11154-019-09518-8.
- Background: PubMed 29738484Cappellano G, Morandi EM, Rainer J, Grubwieser P, Heinz K, Wolfram D, Bernhard D, Lobenwein S, Pierer G, Ploner C. Human Macrophages Preferentially Infiltrate the Superficial Adipose Tissue. Int J Mol Sci. 2018 May 8;19(5):1404. doi: 10.3390/ijms19051404.
- Background: PubMed 31111407Caprio M, Infante M, Moriconi E, Armani A, Fabbri A, Mantovani G, Mariani S, Lubrano C, Poggiogalle E, Migliaccio S, Donini LM, Basciani S, Cignarelli A, Conte E, Ceccarini G, Bogazzi F, Cimino L, Condorelli RA, La Vignera S, Calogero AE, Gambineri A, Vignozzi L, Prodam F, Aimaretti G, Linsalata G, Buralli S, Monzani F, Aversa A, Vettor R, Santini F, Vitti P, Gnessi L, Pagotto U, Giorgino F, Colao A, Lenzi A; Cardiovascular Endocrinology Club of the Italian Society of Endocrinology. Very-low-calorie ketogenic diet (VLCKD) in the management of metabolic diseases: systematic review and consensus statement from the Italian Society of Endocrinology (SIE). J Endocrinol Invest. 2019 Nov;42(11):1365-1386. doi: 10.1007/s40618-019-01061-2. Epub 2019 May 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VLCKD diet with replacing meals and Hypocaloric mediterranean Diet in people with Diabetes Mellitus, Type 2 and Non-alcoholic Fatty Liver Disease, run by Azienda Ospedaliero Universitaria Maggiore della Carita 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight (time frame: Change from Baseline BMI at 15 days, 30 days, 60 days, 90 days). The study lists 4 primary outcomes in all. 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 NCT05275608, which also lists 56 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 10 Sep 2026.