Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04881851
Status:
RECRUITING
Last Update Posted:
2021-05-28
First Post:
2021-05-05
Brief Title:
Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment
Sponsor:
Universita di Verona
Organization:
Universita di Verona
Study Overview
Official Title:
Effects of Inositol Alone or Associated With Alpha-lipoic Acid in Polycystic Ovary Syndrome Treatment
Status:
RECRUITING
Status Verified Date:
2021-05
Last Known Status:
None
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:
IALA
Brief Summary:
The aim of this double-blinded three-armed randomized controlled trial RCT is to evaluate the effects of a 6 months treatment with inositol alone or inositol associated with alpha-lipoic acid in women with polycystic ovary syndrome PCOS
The study population is composed of 90 women with PCOS diagnosed according to the Rotterdam criteria Subjects are randomized to one of the 3 arms of treatment Inositol alpha lipoic acid folic acid vs inositol folic acid vs folic acid alone
At recruitment and after 6 months of treatment the following data are collected
clinical data height weight BMI waist and hip circumference blood pressure Ferriman Gallwey Score menstrual diary
endocrine parameters serum total and free testosterone levels SHBG levels
metabolic profile glycemia and insulinemia at fasting and after oral glucose tolerance test OGTT serum lipids
insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp and surrogate indexes
ovarian ultrasound data Furthermore ovulation is evaluated from the 2nd to the 6th month of the study through progesterone serial dosages on weekly urinary samples
The primary outcome of the study is the serum free testosterone variation after 6 months of treatment Secondary outcomes are the variations of lipid profile ovarian morphology and insulin-sensitivity after 6 months and the number of ovulations occurring in the last 4 months of treatment
The study population is composed of 90 women with PCOS diagnosed according to the Rotterdam criteria Subjects are randomized to one of the 3 arms of treatment Inositol alpha lipoic acid folic acid vs inositol folic acid vs folic acid alone
At recruitment and after 6 months of treatment the following data are collected
clinical data height weight BMI waist and hip circumference blood pressure Ferriman Gallwey Score menstrual diary
endocrine parameters serum total and free testosterone levels SHBG levels
metabolic profile glycemia and insulinemia at fasting and after oral glucose tolerance test OGTT serum lipids
insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp and surrogate indexes
ovarian ultrasound data Furthermore ovulation is evaluated from the 2nd to the 6th month of the study through progesterone serial dosages on weekly urinary samples
The primary outcome of the study is the serum free testosterone variation after 6 months of treatment Secondary outcomes are the variations of lipid profile ovarian morphology and insulin-sensitivity after 6 months and the number of ovulations occurring in the last 4 months of treatment
Detailed Description:
The aim of this study is to evaluate the effects of a 6 months treatment with inositol alone or associated with alpha-lipoic acid in women with PCOS This is a double blinded three-armed RCT
The study population is composed of 90 women with PCOS recruited at the Department of Endocrinology and Metabolic Disease of Azienda Ospedaliera Universitaria Integrata AOUI Verona
After recruitment subjects are randomly assigned to one of the 3 arms of treatment Inositol alpha lipoic acid folic acid vs inositol folic acid vs folic acid alone Randomisation is stratified by BMI category 3 categories 18BMI25 25BMI30 30BMI35 Kgm2 randomisation list is generated by the statistical software Stata 131
At baseline and after 6 months of treatment the following data are collected
clinical examination family and personal medical history menstrual diary physical examination including height weight waist and hip circumferences blood pressure and hirsutism score modified Ferriman-Gallwey score
total and free testosterone and sex hormone binding globulin SHBG blood levels evaluated in the early follicular phase or after 3 months of amenorrhea
metabolic profile glycemia and insulinemia at fasting and after 2h OGTT serum lipids total cholesterol HDL-cholesterol and triglycerides Glycemia and insulinemia values during OGTT will be used to calculate surrogate indexes of insulin resistance
insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp technique Data obtained with this test will be normalized for lean mass measured by bioelectrical impedance The hyperinsulinemic-euglycemic clamp is repeated after 6 months of treatment only in subjects who are insulin-resistant at baseline M-value 86 mgkg min
Chronic inflammation markers CRP
Ovarian ultrasound evaluation including measurement of the 3 diameters for ovarian volume calculation and follicle count The ultrasound examination will be executed by a gynaecologist at the Department of Gynaecology and Obstetrics at AOUI Verona
Furthermore all the study participants are subjected to
ovulation assessment by serial progesterone dosages on weekly urinary samples Patients are given numbered urine beakers and are instructed to collect night urine weekly starting at the 3rd month of treatment and until the end of the study 17 samples
monitoring visits after 2 and 4 months of treatment to evaluate therapy compliance and possible adverse events
30 ml blood samples of the study participants will be preserved for 10 years On these samples further examinations will be considered if new important markers of PCOS will emerge in the future
The study population is composed of 90 women with PCOS recruited at the Department of Endocrinology and Metabolic Disease of Azienda Ospedaliera Universitaria Integrata AOUI Verona
After recruitment subjects are randomly assigned to one of the 3 arms of treatment Inositol alpha lipoic acid folic acid vs inositol folic acid vs folic acid alone Randomisation is stratified by BMI category 3 categories 18BMI25 25BMI30 30BMI35 Kgm2 randomisation list is generated by the statistical software Stata 131
At baseline and after 6 months of treatment the following data are collected
clinical examination family and personal medical history menstrual diary physical examination including height weight waist and hip circumferences blood pressure and hirsutism score modified Ferriman-Gallwey score
total and free testosterone and sex hormone binding globulin SHBG blood levels evaluated in the early follicular phase or after 3 months of amenorrhea
metabolic profile glycemia and insulinemia at fasting and after 2h OGTT serum lipids total cholesterol HDL-cholesterol and triglycerides Glycemia and insulinemia values during OGTT will be used to calculate surrogate indexes of insulin resistance
insulin-sensitivity measured by the hyperinsulinemic-euglycemic clamp technique Data obtained with this test will be normalized for lean mass measured by bioelectrical impedance The hyperinsulinemic-euglycemic clamp is repeated after 6 months of treatment only in subjects who are insulin-resistant at baseline M-value 86 mgkg min
Chronic inflammation markers CRP
Ovarian ultrasound evaluation including measurement of the 3 diameters for ovarian volume calculation and follicle count The ultrasound examination will be executed by a gynaecologist at the Department of Gynaecology and Obstetrics at AOUI Verona
Furthermore all the study participants are subjected to
ovulation assessment by serial progesterone dosages on weekly urinary samples Patients are given numbered urine beakers and are instructed to collect night urine weekly starting at the 3rd month of treatment and until the end of the study 17 samples
monitoring visits after 2 and 4 months of treatment to evaluate therapy compliance and possible adverse events
30 ml blood samples of the study participants will be preserved for 10 years On these samples further examinations will be considered if new important markers of PCOS will emerge in the future
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