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Trial record 50 of 264 for:    Estrogen Resistance

Role of Nesfatin-1 and Nicotinamide in Infertile Women With Polycystic Ovary Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03870035
Recruitment Status : Not yet recruiting
First Posted : March 11, 2019
Last Update Posted : April 26, 2019
Information provided by (Responsible Party):
Hassnaa Mahmoud Abd Elalem, Assiut University

Brief Summary:

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

Detailed Description:
  • 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.

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Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
The PCOS patients included in this study will be selected from out patient's clinic of the department of Obstetrics and Gynaecology at Assiut university hospital, Assiut, Egypt, during one year after the study begins. Informed consent will be obtained from each patient before the examination after explaining the aim of the study to each participant, and the study will be approved by the ethical committee of our institution. The gathered demographic information and complete data will be collected.

Inclusion Criteria:

  • 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:

    1. 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).
    2. 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).
    3. 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03870035

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Contact: Hassnaa M Abd Elaleem, Demonstrator 01145254243
Contact: Enas A Hamed, Professor 01064743592

Sponsors and Collaborators
Assiut University
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Study Director: Hayam G Sayyed, Professor Assiut University

Publications of Results:
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Responsible Party: Hassnaa Mahmoud Abd Elalem, Demonstrator, Assiut University Identifier: NCT03870035     History of Changes
Other Study ID Numbers: NESPCO
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Nicotinic Acids
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents