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

November 15, 2023 updated by: Lo.Li.Pharma s.r.l

The Action of Inositols and Alpha-lactalbumin on Glucose Metabolism, Arterial Stiffness and Vascular Damage in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • L'Aquila, Italy
        • Recruiting
        • UOC Medicina Interna e Nefrologia P.O. AQ
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No intervention
Experimental: Experimental
Dietary Supplement with inositols and alpha-lactalbumin
Dietary supplement: Inositol and alpha-lactalbumin
The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tryglicerides
Time Frame: Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days
Plasmatic levels of tryglicerides
Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days
Hypertension
Time Frame: Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days
sphygmomanometer
Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lo.Li.Pharma s.r.l

Investigators

  • Principal Investigator: Davide Grassi, MD, UOC Medicina Interna e Nefrologia P.O. AQ
  • Principal Investigator: Claudio Ferri, MD, UOC Medicina Interna e Nefrologia P.O. AQ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2022

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARDIO_INO22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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