MYDIAGYM: 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 Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
With diagnosis of Type 2 Mellitus Diabetes for at least 1 year
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Levels of Hb1Ac ranging from 7.5% to 9.0%
Exclusion Criteria:
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Patients that require insulin treatment
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Treated at baseline with food supplements or drugs containing Myo-inositol, D-chiro-inositol, alphalactalbumin, zinc, or Gymnema Sylvestre;
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Any contraindications to the treatment or to any substance used for the treatment
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Subjects with intestinal malabsorption
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Patients subjected to surgery within 6 months before baseline;
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Chronic treatment with systemic corticosteroids
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Basilio Pintaudi | Milan | Italy | 20162 |
Sponsors and Collaborators
- Lo.Li.Pharma s.r.l
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MYO_DCI_GYM_DIABETES