NCT03870035Unknown不适用
Role of Nesfatin-1 and Nicotinamide in Infertile Women With Polycystic Ovary Syndrome
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 主要终点
- Evaluate role of nesfatin-1, nicotinamide and dopamine plasma levels in patients with polycystic ovary syndrome.
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS patients in the age range 18 - 40 years old.
- •Diagnosis of PCOS is based on the 2003 ESHRE/ASRM diagnostic criteria, according to which patients who had at least two of the following conditions are accepted as having PCOS:
- •Oligo or anovulation, defined by the presence of oligomenorrhea or amenorrhea, confirmed by luteal progesterone and normal serum follicle stimulating hormone (FSH) levels (1.0-10.0 IU/L).
- •Clinical hyperandrogenism signs which was defined as the presence of at least one of the following three features: hirsutism, acne, and androgenic alopecia. Biochemical hyperandrogenism was defined as a serum testosterone (T) level >60 ng/dL (>2.08 nmol/L).
- •PCOS manifestation was defined as the presence of >12 unilateral follicles 2-9 mm in size on the ovary or having the least unilateral ovary volume of 10 cm3 by ultrasonography (the measurement was performed when there was no follicle >10 mm). Ovarian volume was calculated by the formula [0.5× ovarian length × thickness × width]. In the case of transabdominal ultrasonography, the presence of at least 10 unilateral antral follicles was required.
排除标准
- •Patients (age <18 or > 40years),
- •Other endocrinology diseases as diabetes mellitus or thyroid disorders, Brain disorders as pituitary adenoma or tumour or brain tumours or masses,
- •Chronic diseases such as cardiovascular, hepatic, hematologic, chronic renal failure, hypertension, and cancer,
- •Use of oral contraceptives, antiandrogenics, glucocorticoids, antihypertensives, antidiabetics and anti-obesity drugs as well as the cigarettes, alcohol, and patients unwilling to participate in the study.
结局指标
主要结局
Evaluate role of nesfatin-1, nicotinamide and dopamine plasma levels in patients with polycystic ovary syndrome.
时间窗: Baseline
Measurement of the circulating plasma levels of nesfatin-1, nicotinamide, and dopamine using the corresponding enzyme linked immunosorbent assay (ELISA) kit
次要结局
- Detect the correlation between nesfatin-1, nicotinamide and dopamine plasma levels and BMI, WHR, insulin resistance, lipid profile, prolactin, LH, FSH, testosterone, estradiol, progesterone.(Baseline)
研究者
Hassnaa Mahmoud Abd Elalem
Demonstrator
Assiut University
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