Evaluation of Efficacy and Safety of a Combination Containing Myo-inositol, D-chiro-inositol, Alpha-lactalbumin, Zinc and Extract of Gymnema Sylvestre in Subjects Diabetic Patients. (MYDIAGYM)

Randomized, Controlled, Open-label Study to Evaluate the Efficacy and Safety of a Combination Containing Myo-inositol, D-chiro-inositol, Alpha-lactalbumin, Zinc and Extract of Gymnema Sylvestre in Subjects With Type 2 Mellitus Diabetes.

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20162
    • Basilio Pintaudi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Arm; 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; 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
Placebo Comparator: Placebo Arm; Treated with Placebo - Two-times daily on an empty stomach, for 6 months.	Dietary supplement: Placebo; Placebo - Two-times daily on an empty stomach, for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemia	Variation of fasting blood sugar level after 3 and 6 months in comparison to baseline detected in the blood - mg/dL	At baseline and 3 and 6 months of treatment
Cholesterol	Variation of cholesterol level (Total, HDL and LDL) after 3 and 6 months in comparison to baseline detected in the blood - mg/dL	At baseline and 3 and 6 months of treatment
Hypoglycemic events	Number of hypoglycemic events (< 70 mg/dl) and severe hypoglycemic events (< 54 mg/dl) during the study (6 months) - Number of events (n)	At baseline and 3 and 6 months of treatment

Collaborators and Investigators

• Sponsor: Lo.Li.Pharma s.r.l

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 9, 2021

Study Record Updates

• Last Update Posted (Estimate): December 26, 2022
• Last Update Submitted That Met QC Criteria: December 23, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Myo-inositol; Gymnema sylvestre
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Inositol
• Other Study ID Numbers: MYO_DCI_GYM_DIABETES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No