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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. (MYDIAGYM)

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ClinicalTrials.gov Identifier: NCT04745780
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Lo.Li.Pharma s.r.l

Study Description
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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
Type 2 Diabetes Dietary Supplement: Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin Dietary Supplement: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 10, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : October 15, 2021

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Glycated hemoglobin [ Time Frame: 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 :
  1. Glycemia [ Time Frame: 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

  2. Cholesterol [ Time Frame: 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

  3. Hypoglycemic events [ Time Frame: 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
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Ages Eligible for Study:   60 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745780


Locations
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Italy
Basilio Pintaudi Recruiting
Milan, Italy, 20162
Contact: Basilio Pintaudi, MD    0039 026444 ext 2464    basilio.pintaudi@ospedaleniguarda.it   
Sponsors and Collaborators
Lo.Li.Pharma s.r.l
More Information
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Responsible Party: Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier: NCT04745780    
Other Study ID Numbers: MYO_DCI_GYM_DIABETES
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lo.Li.Pharma s.r.l:
Type 2 Diabetes
Myo-inositol
Gymnema sylvestre
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Inositol
 Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs