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

L

Lo.Li.Pharma

Status

Completed

Conditions

Insulin Resistance

Treatments

Dietary Supplement: TECADRIOL

Study type

Interventional

Funder types

Industry

Identifiers

NCT05348941
DCI_DIET22

Details and patient eligibility

About

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

Full 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.

Enrollment

44 patients

Sex

Female

Ages

25 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

Control
No Intervention group
Description:
Hypocaloric balanced diet
TECADRIOL
Experimental group
Description:
Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin
Treatment:
Dietary Supplement: TECADRIOL

Trial contacts and locations

1

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Central trial contact

Sabrina Basciani, Dr

Data sourced from clinicaltrials.gov

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