Skip to main content
OpenTrials
Completed

NCT Number: NCT05348941

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sapienza University of Rome

Roma, RM, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TECADRIOL

Dietary Supplement

Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin

Primary outcomes

  1. HOMA index

    Time frame: Three time points: change in HOMA index from the baseline to 2 and 4 months

    Reduction of HOMA index

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Apr 27, 2022
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.