Diabetes Mellitus, Type 2, Metabolic Syndrome, Non-alcoholic Fatty Liver Disease, Obesity
Conditions
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).
Interventions
DIETARY_SUPPLEMENTVLCKD diet with replacing meals
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.
BEHAVIORALHypocaloric mediterranean Diet
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).
Sponsors
Azienda Ospedaliero Universitaria Maggiore della Carita
Laboratoire THERASCIENCE
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 blood glucose at 15 days, 30 days, 60 days, 90 days | Variation of blood glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 kidney profile | Change from Baseline Serum Creatinin at 15 days, 30 days, 60 days, 90 days | Variation of serum creatinin |
| 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 uric acid | Change from Baseline uric acid at 15 days, 30 days, 60 days, 90 days | Variation of uric acid in blood |
| 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 15 days, 30 days, 60 days, 90 days | Change of body composition (fat mass %) (BIVA) |
| Change in muscolar functionality | Change from Baseline scores at 30, 90 days | Changes observed from functional tests (handgrip strenght) |
| Change in hormones | Change from Baseline blood hormones at 15, 30 days, 60 days, 90 days | Variation of hormones in blood (ghrelin, leptin, adiponectin) |
| Change in blood ketones | Change from Baseline blood ketones at 15, 30 days, 60 days, 90 days | Variation of ketones in blood |
| 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 ketones | Change from Baseline urine ketones at 15, 30 days, 60 days, 90 days | Variation of urine excretion in terms of ketones |
| 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 omics profile | Change from Baseline omic profile of stools at 15, 30 days, 60 days, 90 days | Variation of metabolomic profile of stools through liquid and gas chromatography |
| 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 CRP and cytokines at 15, 30 days, 60 days, 90 days | Variation of inflammatory status in blood (C-reactive protein CRP) |
Countries
Italy
Outcome results
None listed