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Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome

U

University of Messina

Status and phase

Unknown
Phase 2

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: myo-inositol
Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT01046500
INOMEN-2010

Details and patient eligibility

About

Myo-Inositol is classified as a member of the vitamin B complex. It is a constituent of living cells and is widespread in many food. It is involved in a number of biological processes, including insulin signal transduction, resulting in modulating insulin sensitivity. One hundred post-menopausal women from 50 to 60 years old, affected by metabolic syndrome (criteria are described in NIH ATP III) will be randomized into two groups: 50 treated with myo-inositol 2 g twice per day and fifty treated with metformin for six months. Metformin is the drug usually used in diabetic and pre-diabetic conditions, as metabolic syndrome. The investigators hypothesize that the administration of myo-inositol would improve the insulin-receptor activity in these women, reducing insulin resistance as well as metformin.

OUTCOME MEASURE: HOMA-IR, blood pressure level, serum triglycerides and cholesterol, BMI and waist circumference

Enrollment

100 estimated patients

Sex

Female

Ages

50 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Post-menopausal outpatients affected by the metabolic syndrome, whose criteria are described in NIH ATP III, 2001.

Exclusion criteria

  • Post-menopausal outpatients without metabolic syndrome
  • assumption of hypocholesterolemic or other insulin sensitizing drugs

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

metformin
Active Comparator group
Treatment:
Drug: Metformin
myo-inositol
Active Comparator group
Treatment:
Dietary Supplement: myo-inositol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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