Role of Nesfatin-1 and Nicotinamide in Infertile Women With Polycystic Ovary Syndrome
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|ClinicalTrials.gov Identifier: NCT03870035|
Recruitment Status : Not yet recruiting
First Posted : March 11, 2019
Last Update Posted : April 26, 2019
evaluation of the potential role of circulating Nesfatin-1 and Nicotinamide in patients with polycystic ovary syndrome.
and detection the correlation between Nesfatin-1 and body mass index (BMI), Waist hip ratio (WHR), blood glucose, insulin, insulin resistance, lipid profiles, prolactin, LH, FSH, estrogen, progesterone, testosterone and dopamine.
|Condition or disease|
- Nesfatin-1 is an 82-amino acid polypeptide derived from the nucleobindin 2 (NUCB2) precursor proteins.
- It is a newly identified peptide. It is released from several tissues including forebrain, hindbrain, brainstem, spinal cord and adipose tissues.
- It plays an important role in hypothalamic pathways such as feeding inhibition, locomotion, stress modulation, thermogenesis, and reproduction.
- Several studies had demonstrated that nesfatin-1 associated with body mass index (BMI), insulin resistance and inflammatory response disorders.
- Polycystic ovary syndrome (PCOS) is one of the most common causes of infertility in women. It is characterized by hyperandrogenism, multiple ovarian cysts, oligomenorrhea/amenorrhea. Many mechanisms had been reported to be responsible for the pathophysiology of PCOS. The condition is thought to be interactions between hypothalamic-pituitary-ovarian, hypothalamic-pituitary-adrenal axis and metabolic disorders.
- The circulating level of nesfatin-1 in PCOS patients is controversial. Some studies reveal lower nesfatin-1 serum levels while others reveal higher level.
- Women with PCOS may have reduced dopamine production from the hypothalamus and elevated prolactin concentrations and this mechanism may be responsible for reproductive disorder.
- In PCOS, stimulation of reactive oxygen species (ROS) generation from mononuclear cells (MNCs) by hyperglycemia . The superoxide radical in particular is a ROS that is generated by the activity of membrane-bound nicotinamide adenine dinucleotide phosphate (NADPH) oxidase.
- Dopaminergic (DA) neurons are highly susceptible to ROS. DA is relatively unstable molecule and undergoes auto-oxidative metabolism in nigro striatal tract system, leading to ROS production. Nicotinamide can reduce hypothalamic dopamine in postnatal brains results in dopamine-deficient phenotypes. Nicotinamide prevents DA release induced by long-term perinatal asphyxia.
|Study Type :||Observational|
|Estimated Enrollment :||56 participants|
|Official Title:||Role of Nesfatin-1 and Nicotinamide in Infertile Women With Polycystic Ovary Syndrome|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
- Evaluate role of nesfatin-1, nicotinamide and dopamine plasma levels in patients with polycystic ovary syndrome. [ Time Frame: Baseline ]Measurement of the circulating plasma levels of nesfatin-1, nicotinamide, and dopamine using the corresponding enzyme linked immunosorbent assay (ELISA) kit
- Detect the correlation between nesfatin-1, nicotinamide and dopamine plasma levels and BMI, WHR, insulin resistance, lipid profile, prolactin, LH, FSH, testosterone, estradiol, progesterone. [ Time Frame: Baseline ]
Determination of homeostasis model of insulin resistance (HOMA-IR): Serum insulin concentration measured using a human insulin ELISA kit. The insulin resistance assessed by homeostasis model assessment estimate of insulin resistance (HOMA-IR):
HOMA-IR = Fasting insulin (IU/ml) × Fasting glucose (mmol/L)/22.5
Determination of lipid profile: Total cholesterol, triglycerides and high density lipoprotein-cholesterol measured by the corresponding kit. Whereas, low density lipoprotein-cholesterol concentrations estimated according to the formula: LDL-cholesterol = Total cholesterol - [HDL-cholesterol + TG/5)].
routine investigation as hormonal assay as estradiol, progesterone, testosterone, prolactin, FSH, LH
Measurement of weight, height, hip circumference, waist circumference
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870035
|Contact: Hassnaa M Abd Elaleem, Demonstratoremail@example.com|
|Contact: Enas A Hamed, Professorfirstname.lastname@example.org|
|Study Director:||Hayam G Sayyed, Professor||Assiut University|