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

Primary Purpose

Insulin Resistance

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
TECADRIOL
Sponsored by
Lo.Li.Pharma s.r.l
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Sapienza University of RomeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

TECADRIOL

Arm Description

Hypocaloric balanced diet

Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin

Outcomes

Primary Outcome Measures

HOMA index
Reduction of HOMA index

Secondary Outcome Measures

Full Information

First Posted
April 22, 2022
Last Updated
November 15, 2022
Sponsor
Lo.Li.Pharma s.r.l
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1. Study Identification

Unique Protocol Identification Number
NCT05348941
Brief Title
Efficacy and Safety of D-chiro-inositol in Obese Patients
Official Title
Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant, Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2022 (Actual)
Primary Completion Date
September 27, 2022 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lo.Li.Pharma s.r.l

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Hypocaloric balanced diet
Arm Title
TECADRIOL
Arm Type
Experimental
Arm Description
Hypocaloric balanced diet plus a food supplement with D-chiro-inositol and alpha-lactalbumin
Intervention Type
Dietary Supplement
Intervention Name(s)
TECADRIOL
Intervention Description
Food supplement containing an association of D-chiro-inositol and alpha-lactalbumin
Primary Outcome Measure Information:
Title
HOMA index
Description
Reduction of HOMA index
Time Frame
Three time points: change in HOMA index from the baseline to 2 and 4 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina Basciani, Dr
Phone
+393392378124
Email
sabrinabasciani@yahoo.it
Facility Information:
Facility Name
Sapienza University of Rome
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina Basciani, Dr
Phone
+393392378124
Email
sabrinabasciani@yahoo.it

12. IPD Sharing Statement

Plan to Share IPD
No

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

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