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

Not Applicable

• Conditions: Insulin Resistance
• Interventions: Dietary Supplement: TECADRIOL

• Registration Number: NCT05348941
• Lead Sponsor: Lo.Li.Pharma s.r.l

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-04-22
• Study First Posted: 2022-04-27
• Status Verified: 2022-06
• Study Start: 2022-06-28
• Primary Completion: 2022-09-27
• Last Update Submitted: 2022-11-15
• Last Update Posted: 2022-11-16
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 44

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TECADRIOL	TECADRIOL	Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin

Primary Outcome Measures

Name	Time	Method
HOMA index	Three time points: change in HOMA index from the baseline to 2 and 4 months	Reduction of HOMA index

Trial Locations

Locations (1)

Sapienza University of Rome; 🇮🇹 Roma, RM, Italy