PCOSNCT03870035
Role of Nesfatin-1 and Nicotinamide in Infertile Women With Polycystic Ovary Syndrome
An observational study of PCOS, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- PCOS
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- PCOS
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate role of nesfatin-1, nicotinamide and dopamine plasma levels in patients with polycystic ovary syndrome.
Measurement of the circulating plasma levels of nesfatin-1, nicotinamide, and dopamine using the corresponding enzyme linked immunosorbent assay (ELISA) kit
Measured: Baseline
Secondary outcomes (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.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 May 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassnaa Mahmoud Abd Elalem, Assiut University
- Investigators
- Hayam G Sayyed, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870035
- Sponsor's protocol ID
- NESPCO
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Slivka A, Cohen G. Hydroxyl radical attack on dopamine. J Biol Chem. 1985 Dec 15;260(29):15466-72.
PubMed 2999117Oh-I S, Shimizu H, Satoh T, Okada S, Adachi S, Inoue K, Eguchi H, Yamamoto M, Imaki T, Hashimoto K, Tsuchiya T, Monden T, Horiguchi K, Yamada M, Mori M. Identification of nesfatin-1 as a satiety molecule in the hypothalamus. Nature. 2006 Oct 12;443(7112):709-12. doi: 10.1038/nature05162. Epub 2006 Oct 1.
PubMed 17036007Sahin FK, Sahin SB, Ural UM, Cure MC, Senturk S, Tekin YB, Balik G, Cure E, Yuce S, Kirbas A. Nesfatin-1 and Vitamin D levels may be associated with systolic and diastolic blood pressure values and hearth rate in polycystic ovary syndrome. Bosn J Basic Med Sci. 2015 Jul 9;15(3):57-63. doi: 10.17305/bjbms.2015.432.
PubMed 26295295Yosten GL, Samson WK. The anorexigenic and hypertensive effects of nesfatin-1 are reversed by pretreatment with an oxytocin receptor antagonist. Am J Physiol Regul Integr Comp Physiol. 2010 Jun;298(6):R1642-7. doi: 10.1152/ajpregu.00804.2009. Epub 2010 Mar 24.
PubMed 20335376Kostal M, Tosner J. The influence of latent hyperprolactinaemia on the levels of LH, FSH, E2 and T in the midfollicular phase of the cycle. Arch Gynecol Obstet. 1997;259(2):65-8.
PubMed 9059746
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nesfatin-1 and Nicotinamide in Infertile Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03870035
- Acronym / sponsor ID
- NESPCO
- Conditions
- PCOS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Results publication: PubMed 2999117Slivka A, Cohen G. Hydroxyl radical attack on dopamine. J Biol Chem. 1985 Dec 15;260(29):15466-72.
- Results publication: PubMed 17036007Oh-I S, Shimizu H, Satoh T, Okada S, Adachi S, Inoue K, Eguchi H, Yamamoto M, Imaki T, Hashimoto K, Tsuchiya T, Monden T, Horiguchi K, Yamada M, Mori M. Identification of nesfatin-1 as a satiety molecule in the hypothalamus. Nature. 2006 Oct 12;443(7112):709-12. doi: 10.1038/nature05162. Epub 2006 Oct 1.
- Results publication: PubMed 26295295Sahin FK, Sahin SB, Ural UM, Cure MC, Senturk S, Tekin YB, Balik G, Cure E, Yuce S, Kirbas A. Nesfatin-1 and Vitamin D levels may be associated with systolic and diastolic blood pressure values and hearth rate in polycystic ovary syndrome. Bosn J Basic Med Sci. 2015 Jul 9;15(3):57-63. doi: 10.17305/bjbms.2015.432.
- Results publication: PubMed 20335376Yosten GL, Samson WK. The anorexigenic and hypertensive effects of nesfatin-1 are reversed by pretreatment with an oxytocin receptor antagonist. Am J Physiol Regul Integr Comp Physiol. 2010 Jun;298(6):R1642-7. doi: 10.1152/ajpregu.00804.2009. Epub 2010 Mar 24.
- Results publication: PubMed 9059746Kostal M, Tosner J. The influence of latent hyperprolactinaemia on the levels of LH, FSH, E2 and T in the midfollicular phase of the cycle. Arch Gynecol Obstet. 1997;259(2):65-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hayam G Sayyed, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hassnaa M Abd Elaleem, Demonstrator (01145254243, hassnaamahmoud91@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate role of nesfatin-1, nicotinamide and dopamine plasma levels in patients with polycystic ovary syndrome. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03870035, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.