Effects of VLCKD in Metabolic Syndrome

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Obesity; Metabolic Syndrome
• Interventions: Dietary Supplement: VLCKD diet with replacing meals; Behavioral: Hypocaloric mediterranean Diet

• Registration Number: NCT05275608
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-21
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-11
• Study Start: 2022-11-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VLCKD	VLCKD diet with replacing meals	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 %.
Hypocaloric Mediterranean Diet	Hypocaloric mediterranean Diet	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 %.

Primary Outcome Measures

Name	Time	Method
Change in weight	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	Change from Baseline circumferences at 15 days, 30 days, 60 days, 90 days	Variation of body circumferences (waist, hips)
Change in metabolic control	Change from Baseline lipid profile at 15 days, 30 days, 60 days, 90 days	Change of cardio-metabolic risk factors: lipid profile

Secondary Outcome Measures

Name	Time	Method
Change in uric acid	Change from Baseline uric acid at 15 days, 30 days, 60 days, 90 days	Variation of uric acid in blood
Change in kidney profile	Change from Baseline Serum Creatinin at 15 days, 30 days, 60 days, 90 days	Variation of serum creatinin
Change in blood pressure	Change from Baseline blood pressure at 15 days, 30 days, 60 days, 90 days	Variation of blood pressure (diastolic and sistolic)
Change in body composition	Change from Baseline fat mass% at 90 days	Change of body composition (fat mass %) (DXA)
Change in Metabolic control	Change from Baseline HOMA-IR at 15 days, 30 days, 60 days, 90 days	Change of cardio-metabolic risk factors: insulin resistance (HOMA-IR)
Change in liver profile	Change from Baseline liver profile at 15 days, 30 days, 60 days, 90 days	Variation of liver profile (AST, ALT, GGT, bilirubin)
Change in muscolar functionality	Change from Baseline scores at 30, 90 days	Changes observed from functional tests (time up and go test)
Change in hormones	Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days	Variation of hormones in blood (IGF-1)
Change in blood ketones	Change from Baseline blood ketones at 15, 30 days, 60 days, 90 days	Variation of ketones in blood
Change in urine ketones	Change from Baseline urine ketones at 15, 30 days, 60 days, 90 days	Variation of urine excretion in terms of ketones
Change in omics profile	Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days	Variation of proteomic profile of stools through liquid and gas chromatography
Change in basal metabolic rate	Change from Baseline basal metabolic rate at 90 days	Variation of basal metabolic rate through indirect calorimetry
Change in urine nitrogen excretion	Change from Baseline urine nitrogen at 15, 30 days, 60 days, 90 days	Variation of urine excretion in terms of nitrogen
Change in microbiota	Change from Baseline of prevalence of microbiota phyla at 15, 30 days, 60 days, 90 days	Variation of prevalence of microbiota phyla through DNA sequencing of stools
Change in inflammatory status	Change from Baseline cytokines at 15, 30 days, 60 days, 90 days	Variation of inflammatory status in blood (cytokines count)

Trial Locations

Locations (1)

: Italy Pediatric Endocrine Service of AOU Maggiore della Carità of Novara; SCDU of Pediatrics, Department of Health Sciences, University of Eastern Piedmont; 🇮🇹 Novara, Italy