Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05348941
Status:
UNKNOWN
Last Update Posted:
2022-11-16
First Post:
2022-04-22
Brief Title:
Efficacy and Safety of D-chiro-inositol in Obese Patients
Sponsor:
LoLiPharma srl
Organization:
LoLiPharma srl
Study Overview
Official Title:
Evaluation o Efficacy and Safety of D-chiro-inositol in Insulin Resistant Obese Patients
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 overweightobese 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 overweightobese 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
However although the insulin value is reduced with diet it does not reach the levels found in overweightobese 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None