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NCT05348941 Clinical Trial

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

Insulin Resistance Clinical Trial

Official title:
Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant, Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05348941
Other study ID # DCI_DIET22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 28, 2022
Est. completion date December 2022

Study information
Verified date June 2022
Source Lo.Li.Pharma s.r.l
Contact Sabrina Basciani, Dr
Phone +393392378124
Email sabrinabasciani@yahoo.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 44
Est. completion date December 2022
Est. primary completion date September 27, 2022
Accepts healthy volunteers No
Gender Female
Age group 25 Years to 40 Years
Eligibility Inclusion Criteria: - Women between 25 and 40 years old - Diagnosis of insulin resistance (HOMA =2.5) - 26= 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

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• TECADRIOL
Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin

Locations
Country Name City State
Italy Sapienza University of Rome Roma RM

Sponsors (1)
Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary HOMA index Reduction of HOMA index Three time points: change in HOMA index from the baseline to 2 and 4 months
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