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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Arm<br>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<br>* 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<br>|
| Placebo Comparator: Placebo Arm<br>Treated with Placebo - Two-times daily on an empty stomach, for 6 months. | Dietary Supplement: Placebo<br>* Placebo - Two-times daily on an empty stomach, for 6 months<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Myo-inositol, Gymnema sylvestre