Clinical trial NCT05275608: Effects of VLCKD in Metabolic Syndrome
Official title: Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients with Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Non-alcoholic Fatty Liver Disease
Obesity
Metabolic Syndrome
Lead sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita
Sponsor class: OTHER
Collaborators: name: Laboratoire THERASCIENCE
First posted: 2022-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).


Eligibility criteria: Inclusion Criteria:

* 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 %.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in weight
timeFrame: Change from Baseline BMI at 15 days, 30 days, 60 days, 90 days
measure: Change in body circumferences
timeFrame: Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days
measure: Change in metabolic control
timeFrame: Change from Baseline blood glucose at 15 days, 30 days, 60 days, 90 days
measure: Change in metabolic control
timeFrame: Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days
Secondary outcomes:
measure: Change in Metabolic control
timeFrame: Change from Baseline HOMA-IR at 15 days, 30 days, 60 days, 90 days
measure: Change in kidney profile
timeFrame: Change from Baseline Serum Creatinin at 15 days, 30 days, 60 days, 90 days
measure: Change in liver profile
timeFrame: Change from Baseline liver profile at 15 days, 30 days, 60 days, 90 days
measure: Change in uric acid
timeFrame: Change from Baseline uric acid at 15 days, 30 days, 60 days, 90 days
measure: Change in blood pressure
timeFrame: Change from Baseline blood pressure at 15 days, 30 days, 60 days, 90 days
measure: Change in body composition
timeFrame: Change from Baseline fat mass% at 15 days, 30 days, 60 days, 90 days
measure: Change in body composition
timeFrame: Change from Baseline fat mass% at 90 days
measure: Change in muscolar functionality
timeFrame: Change from Baseline scores at 30, 90 days
measure: Change in muscolar functionality
timeFrame: Change from Baseline scores at 30, 90 days
measure: Change in muscolar functionality
timeFrame: Change from Baseline scores at 30, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in hormones
timeFrame: Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days
measure: Change in blood ketones
timeFrame: Change from Baseline blood ketones at 15, 30 days, 60 days, 90 days
measure: Change in basal metabolic rate
timeFrame: Change from Baseline basal metabolic rate at 90 days
measure: Change in urine ketones
timeFrame: Change from Baseline urine ketones at 15, 30 days, 60 days, 90 days
measure: Change in urine nitrogen excretion
timeFrame: Change from Baseline urine nitrogen at 15, 30 days, 60 days, 90 days
measure: Change in omics profile
timeFrame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
measure: Change in omics profile
timeFrame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
measure: Change in omics profile
timeFrame: Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days
measure: Change in microbiota
timeFrame: Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 60 days, 90 days
measure: Change in inflammatory status
timeFrame: Change from Baseline CRP and cytokines at 15, 30 days, 60 days, 90 days
measure: Change in inflammatory status
timeFrame: Change from Baseline cytokines at 15, 30 days, 60 days, 90 days
Other outcomes:
Locations:
city: Novara
country: Italy
facility: : Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont
Study officials:
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