Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04867252
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2021-04-24
Brief Title:
Effects of Combined Resveratrol and Myo-inositol on Altered Metabolic Endocrine Parameters and Perceived Stress in Patients With Polycystic Ovarian Syndrome
Sponsor:
Khyber Medical University Peshawar
Organization:
Khyber Medical University Peshawar
Study Overview
Official Title:
Effects of Combined Resveratrol and Myo-inositol on Altered Metabolic Endocrine Parameters and Perceived Stress in Patients With Polycystic Ovarian Syndrome
Status:
COMPLETED
Status Verified Date:
2021-09
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:
None
Brief Summary:
The investigators aim is to conduct a double blind randomized clinical trial to study the effects of combined Resveratrol and Myo-Inositol on altered metabolic endocrine parameters and perceived stress response in patients with Polycystic Ovary Syndrome PCOS Women diagnosed with PCOS using criteria proposed in November 2015 by the American Association of Clinical Endocrinologists AACE American College of Endocrinology ACE and Androgen Excess and PCOS Society AES for PCOS should include two of the following three criteria chronic an ovulation hyperandrogenism clinicalbiologic and polycystic ovaries The investigators propose that PCOS women may have altered metabolic endocrine levels and increased perceived stress response and combination therapy may have beneficial influences on these parameters in women diagnosed with PCOS
Detailed Description:
Polycystic ovarian syndrome PCOS is extremely prevalent and considered to be the most common heterogeneous endocrine disorder in reproductive age women This affects up to 10-15 of women in reproductive age PCOS is a multifaceted health issue characterized by chronic anovulation with excess ovarian activity hyperandrogenism and polycystic ovaries The most disappointment for women with PCOS is pregnancy loss
This endocrine disorder has some long term effects including cardiovascular diseases metabolic and sexual dysfunction depression and anxiety that effects the overall quality of life Women with PCOS have a greater risk of developing hyperinsulinemia and insulin resistance and this explains the substantially increased prevalence of glucose intolerance in PCOS Recent long-term follow up studies of the syndrome have shown that dyslipidemia and hyperlipidemia is a very common metabolic abnormality in these women The key pathophysiology of PCOS is Insulin resistance thus dyslipidemia in women may be constant with those found in an insulin resistant state Low adiponectin levels in PCOS have been largely associated with obesity which is common among these patients Serum adiponectin levels are associated with PCOS independently and are only explained by IR partly An independent biomarker adiponectin can be used for diagnosing PCOS in young and lean women or women with a family history of PCOS
Resveratrol 354-trihydroxy-trans-stilbene belongs to polyphenols stilbene group found in grapes peanuts red wine and many medicinal plants Studies have shown that patients treated with resveratrol have shown improve glucose homeostasis and reverse insulin resistance Treatment with resveratrol improved the elevated number of atretic and secondary follicles and the decreased number of Graafian follicles in the PCOS group which indicates the effect of the treatments on the maintenance of folliculogenesis It has been reported to interact with multiple cell targets but its major effects are brought about by the activation of SIRT1 silent information regulator1The SIRT1 is expressed in oocytes and human granulosa nuclei cells at multiple developmental stages of the follicles It is also responsible for suppressing inflammation Moreover SIRT1 is also involved in protecting the oocytes from age dependent insufficiencies through oxidative stress
Myo-Inositol is a carbocyclic sugar belongs to Inositol group and is an important component of structural lipids Inositols or its phosphates and the associated lipids are found in different fruits specially cantaloupe and oranges It is the precursor of inositol triphosphate acting as an intracellular second messenger and regulating a number of hormones such as thyroid-stimulating hormone follicle-stimulating hormone FSH and insulin One of the insulin-sensitizing compounds Myo-Inositol is capable of restoring spontaneous ovarian activity and consequently fertility in most patients with PCOS Inositols improve the metabolic and endocrine parameters in young overweight PCOS patients and regulate the monthly cycles Treatment with inositols in obese PCOS patients is also effective in reducing BMI The decrease in BMI is without any lifestyle modification
PCOS is a systemic condition an endocrinopathy whose etiology is still not understood correct treatment regimens of PCOS will not only improve menstrual cycles of the patients but will also improve the metabolic or endocrinological parameters PCOS sufferers are also known to have increased levels of perceived stress which will be considered in the study Very little evidence is available on combination therapy for treatment of PCOS patients In this study our goal will be to come up with a better treatment option to treat the disease effectively
Study Objectives
To investigate the effects of combined Resveratrol and Myo-Inositol treatment after 3 months on metabolic endocrine alterations and perceived stress response in patients with PCOS
This endocrine disorder has some long term effects including cardiovascular diseases metabolic and sexual dysfunction depression and anxiety that effects the overall quality of life Women with PCOS have a greater risk of developing hyperinsulinemia and insulin resistance and this explains the substantially increased prevalence of glucose intolerance in PCOS Recent long-term follow up studies of the syndrome have shown that dyslipidemia and hyperlipidemia is a very common metabolic abnormality in these women The key pathophysiology of PCOS is Insulin resistance thus dyslipidemia in women may be constant with those found in an insulin resistant state Low adiponectin levels in PCOS have been largely associated with obesity which is common among these patients Serum adiponectin levels are associated with PCOS independently and are only explained by IR partly An independent biomarker adiponectin can be used for diagnosing PCOS in young and lean women or women with a family history of PCOS
Resveratrol 354-trihydroxy-trans-stilbene belongs to polyphenols stilbene group found in grapes peanuts red wine and many medicinal plants Studies have shown that patients treated with resveratrol have shown improve glucose homeostasis and reverse insulin resistance Treatment with resveratrol improved the elevated number of atretic and secondary follicles and the decreased number of Graafian follicles in the PCOS group which indicates the effect of the treatments on the maintenance of folliculogenesis It has been reported to interact with multiple cell targets but its major effects are brought about by the activation of SIRT1 silent information regulator1The SIRT1 is expressed in oocytes and human granulosa nuclei cells at multiple developmental stages of the follicles It is also responsible for suppressing inflammation Moreover SIRT1 is also involved in protecting the oocytes from age dependent insufficiencies through oxidative stress
Myo-Inositol is a carbocyclic sugar belongs to Inositol group and is an important component of structural lipids Inositols or its phosphates and the associated lipids are found in different fruits specially cantaloupe and oranges It is the precursor of inositol triphosphate acting as an intracellular second messenger and regulating a number of hormones such as thyroid-stimulating hormone follicle-stimulating hormone FSH and insulin One of the insulin-sensitizing compounds Myo-Inositol is capable of restoring spontaneous ovarian activity and consequently fertility in most patients with PCOS Inositols improve the metabolic and endocrine parameters in young overweight PCOS patients and regulate the monthly cycles Treatment with inositols in obese PCOS patients is also effective in reducing BMI The decrease in BMI is without any lifestyle modification
PCOS is a systemic condition an endocrinopathy whose etiology is still not understood correct treatment regimens of PCOS will not only improve menstrual cycles of the patients but will also improve the metabolic or endocrinological parameters PCOS sufferers are also known to have increased levels of perceived stress which will be considered in the study Very little evidence is available on combination therapy for treatment of PCOS patients In this study our goal will be to come up with a better treatment option to treat the disease effectively
Study Objectives
To investigate the effects of combined Resveratrol and Myo-Inositol treatment after 3 months on metabolic endocrine alterations and perceived stress response in patients with PCOS
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