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)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    128
  • sponsor
    Lo.Li.Pharma s.r.l
Updated on 25 April 2022
insulin
chronic disease
insulin resistance

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.

Details
Condition Type 2 Diabetes
Treatment Placebo, Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin
Clinical Study IdentifierNCT04745780
SponsorLo.Li.Pharma s.r.l
Last Modified on25 April 2022

Eligibility

Yes No Not Sure

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
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