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.

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin; Dietary Supplement: Placebo

• Registration Number: NCT04745780
• Lead Sponsor: Lo.Li.Pharma s.r.l

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-09
• Study Start: 2021-02-10
• Status Verified: 2022-04
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-22
• Last Update Submitted: 2022-12-23
• Last Update Posted: 2022-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Arm	Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin	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.
Placebo Arm	Placebo	Treated with Placebo - Two-times daily on an empty stomach, for 6 months.

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin	up to 6 months of treatment	Variation of glycated hemoglobin level (HbA1c) after 3 and 6 months in comparison to baseline detected in the blood - %

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Basilio Pintaudi; 🇮🇹 Milan, Italy