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)

Lo.Li.Pharma

Status: Completed

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04745780

MYO_DCI_GYM_DIABETES

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 60 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 2 patient groups, including a placebo group

Study Arm

Experimental group

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.

Treatment:

Dietary Supplement: Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin

Placebo Arm

Placebo Comparator group

Description:

Treated with Placebo - Two-times daily on an empty stomach, for 6 months.

Treatment:

Dietary Supplement: Placebo