Back to resultsEvaluation 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)
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Myo-inositol, Gymnema sylvestre
Eligibility Criteria
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
Sites / Locations
- Basilio Pintaudi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Study Arm
Placebo Arm
Arm Description
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.
Treated with Placebo - Two-times daily on an empty stomach, for 6 months.
Outcomes
Primary Outcome Measures
Glycated hemoglobin
Variation of glycated hemoglobin level (HbA1c) after 3 and 6 months in comparison to baseline detected in the blood - %
Secondary Outcome Measures
Glycemia
Variation of fasting blood sugar level after 3 and 6 months in comparison to baseline detected in the blood - mg/dL
Cholesterol
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
Number of hypoglycemic events (< 70 mg/dl) and severe hypoglycemic events (< 54 mg/dl) during the study (6 months) - Number of events (n)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04745780
Brief Title
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.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 Diabetes, Myo-inositol, Gymnema sylvestre
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Treated with Placebo - Two-times daily on an empty stomach, for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo - Two-times daily on an empty stomach, for 6 months
Primary Outcome Measure Information:
Title
Glycated hemoglobin
Description
Variation of glycated hemoglobin level (HbA1c) after 3 and 6 months in comparison to baseline detected in the blood - %
Time Frame
up to 6 months of treatment
Secondary Outcome Measure Information:
Title
Glycemia
Description
Variation of fasting blood sugar level after 3 and 6 months in comparison to baseline detected in the blood - mg/dL
Time Frame
At baseline and 3 and 6 months of treatment
Title
Cholesterol
Description
Variation of cholesterol level (Total, HDL and LDL) after 3 and 6 months in comparison to baseline detected in the blood - mg/dL
Time Frame
At baseline and 3 and 6 months of treatment
Title
Hypoglycemic events
Description
Number of hypoglycemic events (< 70 mg/dl) and severe hypoglycemic events (< 54 mg/dl) during the study (6 months) - Number of events (n)
Time Frame
At baseline and 3 and 6 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Basilio Pintaudi
City
Milan
ZIP/Postal Code
20162
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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