Back to resultsThe Effects of Inositol on Glucose Metabolism in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis
Primary Purpose
Metabolic Syndrome, Cardiac Fibrosis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Inositol and alpha-lactalbumin
Sponsored by
About this trial
This is an interventional supportive care trial for Metabolic Syndrome
Eligibility Criteria
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
Sites / Locations
- UOC Medicina Interna e Nefrologia P.O. AQRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No intervention
Experimental
Arm Description
Dietary Supplement with inositols and alpha-lactalbumin
Outcomes
Primary Outcome Measures
Body weight
Secondary Outcome Measures
Tryglicerides
Plasmatic levels of tryglicerides
Hypertension
sphygmomanometer
Full Information
NCT ID
NCT05689710
First Posted
December 23, 2022
Last Updated
September 13, 2023
Sponsor
Lo.Li.Pharma s.r.l
1. Study Identification
Unique Protocol Identification Number
NCT05689710
Brief Title
The Effects of Inositol on Glucose Metabolism in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 23, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Cardiac Fibrosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No intervention
Arm Type
No Intervention
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Dietary Supplement with inositols and alpha-lactalbumin
Intervention Type
Dietary Supplement
Intervention Name(s)
Inositol and alpha-lactalbumin
Intervention Description
The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days)
Primary Outcome Measure Information:
Title
Body weight
Time Frame
Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days
Secondary Outcome Measure Information:
Title
Tryglicerides
Description
Plasmatic levels of tryglicerides
Time Frame
Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days
Title
Hypertension
Description
sphygmomanometer
Time Frame
Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Davide Grassi, MD
Phone
+393332123716
Email
davide.grassi@cc.univaq.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Davide Grassi, MD
Organizational Affiliation
UOC Medicina Interna e Nefrologia P.O. AQ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudio Ferri, MD
Organizational Affiliation
UOC Medicina Interna e Nefrologia P.O. AQ
Official's Role
Principal Investigator
Facility Information:
Facility Name
UOC Medicina Interna e Nefrologia P.O. AQ
City
L'Aquila
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Davide Grassi, MD
Phone
333 2123716
Email
davide.grassi@cc.univaq.it
12. IPD Sharing Statement
Learn more about this trial
The Effects of Inositol on Glucose Metabolism in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis
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