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.

Type 2 Diabetes Clinical Trial

— MYDIAGYM  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04745780
• Other study ID #: MYO_DCI_GYM_DIABETES
• Status: Completed
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: December 22, 2022

Study information

• Verified date: April 2022
• Source: Lo.Li.Pharma s.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 22, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Italy	Basilio Pintaudi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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