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

NCT ID: NCT05689710

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-23

Study Completion Date

2026-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Metabolic Syndrome Cardiac Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental

Dietary Supplement with inositols and alpha-lactalbumin

Group Type EXPERIMENTAL

Inositol and alpha-lactalbumin

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Inositol and alpha-lactalbumin

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lo.Li.Pharma s.r.l

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Davide Grassi, MD

Role: PRINCIPAL_INVESTIGATOR

UOC Medicina Interna e Nefrologia P.O. AQ

Claudio Ferri, MD

Role: PRINCIPAL_INVESTIGATOR

UOC Medicina Interna e Nefrologia P.O. AQ

Locations

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UOC Medicina Interna e Nefrologia P.O. AQ

L’Aquila, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CARDIO_INO22

Identifier Type: -

Identifier Source: org_study_id