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

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

Study Overview

• Status: Recruiting
• Conditions: Insulin Resistance
• Intervention / Treatment: Dietary supplement: TECADRIOL

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00161
      • Recruiting
      • Sapienza University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Hypocaloric balanced diet
EXPERIMENTAL: TECADRIOL; Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin	Dietary supplement: TECADRIOL; Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA index	Reduction of HOMA index	Three time points: change in HOMA index from the baseline to 2 and 4 months

Collaborators and Investigators

• Sponsor: Lo.Li.Pharma s.r.l

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 28, 2022
• Primary Completion (ACTUAL): September 27, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: April 22, 2022
• First Posted (ACTUAL): April 27, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: DCI_DIET22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No