NCT04745780

Brief Summary

Mellitus type 2 diabetes (T2MD) is a chronic disease characterized by high glucose plasmatic level due to an alteration of insulin function. Several authors have correlated this altered function to an inositol depletion. The main present member of inositol family in biological systems is undoubtedly myo-inositol, a precursor of several second messengers, widely involved in insulin signalling. For this reason this molecule is considered an insulin-sensitizer. The high excretion of inositol in T2MD patients is frequent, inducing a myo-inositol depleted state that favours the onset of insulin resistance, impairing the activity of this hormone. The aim of this study is to evaluate the efficacy and the safety of a food supplement containing myo-inositol in T2MD patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

February 10, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

February 5, 2021

Last Update Submit

May 29, 2025

Conditions

Type 2 Diabetes

Keywords

Type 2 DiabetesMyo-inositolGymnema sylvestre

Outcome Measures

Primary Outcomes (1)

  • Glycated hemoglobin

    Variation of glycated hemoglobin level (HbA1c) after 3 and 6 months in comparison to baseline detected in the blood - %

    up to 6 months of treatment

Secondary Outcomes (3)

  • Glycemia

    At baseline and 3 and 6 months of treatment

  • Cholesterol

    At baseline and 3 and 6 months of treatment

  • Hypoglycemic events

    At baseline and 3 and 6 months of treatment

Study Arms (2)

Study Arm

EXPERIMENTAL

Treated with a formulation containing Myo-inositol (1950 mg), D-chiro-inositol (50 mg), Gymnema sylvestre (250 mg), Zinc (7,5 mg) and Alpha-lactalbumin (50 mg) - Two-times daily on an empty stomach, for 6 months.

Dietary Supplement: Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin

Placebo Arm

PLACEBO COMPARATOR

Treated with Placebo - Two-times daily on an empty stomach, for 6 months.

Dietary Supplement: Placebo

Interventions

Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbuminDIETARY_SUPPLEMENT

Myo-inositol (1950 mg), D-chiro-inositol (50 mg), Gymnema sylvestre (250 mg), Zinc (7,5 mg) and Alpha-lactalbumin (50 mg) - Two-times daily on an empty stomach, for 6 months

Study Arm
PlaceboDIETARY_SUPPLEMENT

Placebo - Two-times daily on an empty stomach, for 6 months

Placebo Arm

Eligibility Criteria

Age60 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With diagnosis of Type 2 Mellitus Diabetes for at least 1 year
  • Levels of Hb1Ac ranging from 7.5% to 9.0%

You may not qualify if:

  • Patients that require insulin treatment
  • Treated at baseline with food supplements or drugs containing Myo-inositol, D-chiro-inositol, alphalactalbumin, zinc, or Gymnema Sylvestre;
  • Any contraindications to the treatment or to any substance used for the treatment
  • Subjects with intestinal malabsorption
  • Patients subjected to surgery within 6 months before baseline;
  • Chronic treatment with systemic corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basilio Pintaudi

Milan, 20162, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

InositolZincLactalbumin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsAlbuminsProteinsAmino Acids, Peptides, and ProteinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 9, 2021

Study Start

February 10, 2021

Primary Completion

September 30, 2022

Study Completion

December 22, 2022

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)