The Effects of Inositol on Glucose Metabolism in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis

Lo.Li.Pharma s.r.l30 enrolled

Overview

The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Metabolic Syndrome Cardiac Fibrosis

Interventions

Inositol and alpha-lactalbuminDIETARY_SUPPLEMENT

The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

At least 3 of the following inclusion criteria: * triglycerides levels ≥ 150 mg/dL * HDL ≤ 40 mg/dL * Fasting glycemia \> 100 mg/dL \<126 mg/dl * Systolic Pressure ≥ 130 mmHg or Diastolic pressure ≥ 85 mmHg * Hip circumference \> 102 cm in men or 88 cm in women

Locations (1)

UOC Medicina Interna e Nefrologia P.O. AQ

L’Aquila, Italy

Outcomes

Primary Outcomes

Body weight

Time frame: Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days

Secondary Outcomes

Tryglicerides

Plasmatic levels of tryglicerides

Time frame: Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days

Hypertension

sphygmomanometer

Time frame: Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days

Data from ClinicalTrials.gov

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