Efficacy and Safety of D-chiro-inositol in Obese Patients

  • STATUS
    Recruiting
  • days left to enroll
    9
  • participants needed
    44
  • sponsor
    Lo.Li.Pharma s.r.l
Updated on 11 July 2022

Summary

The study aims to evaluate the efficacy and tolerability of a food supplement based on D-chiro-inositol in overweight or obese women with insulin resistance, who are approaching a hypocaloric diet

Description

Scientific studies on overweight/obese non-diabetic subjects have shown that weight loss improves insulin sensitivity. In fact, in these subjects weight loss reduces the insulin response to the oral glucose load and lowers plasma concentration of triglycerides.

However, although the insulin value is reduced with diet, it does not reach the levels found in overweight/obese non-insulin resistant subjects.

It has been shown that the supplementation of D-chiro-inositol (DCI), a polyol with an insulin-sensitizing action, can positively affect insulin resistance, avoiding the typical side effects of classic insulin sensitizers. In fact, DCI improves glucose tolerance and increases insulin sensitivity, as demonstrated in hyperinsulinemic women with polycystic ovary syndrome.

Therefore, considering the role of DCI, we want to investigate the efficacy and tolerability of a DCI-based product in overweight / obese women with insulin resistance who are approaching a low-calorie diet.

Details
Condition Insulin Resistance
Treatment TECADRIOL
Clinical Study IdentifierNCT05348941
SponsorLo.Li.Pharma s.r.l
Last Modified on11 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Women between 25 and 40 years old
Diagnosis of insulin resistance (HOMA ≥2.5)
≤ BMI ≤32

Exclusion Criteria

Subjects with no indication for treatment
Pregnancy and breastfeeding
Treatment with drugs or supplements that interfere with the mechanism of action of insulin
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