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Trial record 19 of 1345 for:    "Seizure Disorder"

Serum and Urine Ghrelin in Adult Epileptic Patients

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ClinicalTrials.gov Identifier: NCT03926273
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
rania sanad, Zagazig University

Brief Summary:
Several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. There is a potential relation between its level and antiepileptic drugs (AED) response.

Condition or disease
Epilepsy

Detailed Description:
Several neuropeptides have concerned with epilepsy pathogenesis, ghrelin showed an anticonvulsant effect. There is a potential relation between its level and antiepileptic drugs (AED) response. Objective: to evaluate ghrelin effect in adult epileptic patients and in response to AED. Methods: This case control study included 40 adult epileptic patients and 40 healthy controls. Participants were subjected to history taking of seizure semiology, full general and neurological examination, electroencephalography and cranial CT or MRI. Fasting serum acylated ghrelin (AG) and unacylated ghrelin (UAG) and urine AG levels were estimated to all participants by enzyme - linked immunosorbent assay (ELIZA).

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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Serum and Urine Ghrelin in Adult Epileptic Patients
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : February 5, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
group 1
Epileptic participants group consisted of 40 adults (15 females and 25 males) clinically and electrophysiological were diagnosed according to the international league against epilepsy classification 2010.
group 2
Control group consisted of 40 adults (16 females and 24 males) non - epileptic healthy subjects.



Primary Outcome Measures :
  1. Serum ghrelin in Adult Epileptic Patients [ Time Frame: 6 months ]
    evaluation of the effect of Serum ghrelin in adult epileptic patients and in their response to anti- epileptic drugs

  2. Urine ghrelin in Adult Epileptic Patients [ Time Frame: 6 months ]
    evaluation of the effect of Urine ghrelin in adult epileptic patients and in their response to anti- epileptic drugs



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
The present study was a case control type. All patients were selected from out- patient clinic of Neurology department, Zagazig university hospitals, Sharkia Governorate, Egypt in the period from July 2018 to January 2019.
Criteria

Inclusion Criteria:

  • All participants were included if their age more than or equal to 18 years. Body mass index < 30 kg/m2, total cholesterol < 200mg/dl, serum triglycerides < 200 mg/dl and random blood glucose level < 126 mg/dl.

Exclusion Criteria:

  • Participants had acute or chronic metabolic disorders (liver, kidney, thyroid, endocrine or gastrointestinal disorders).
  • Females with irregular menstrual cycle or on estrogen therapy (7).
  • Participants with organic cerebral lesion that was detected on cranial computed tomography (CT) or cranial magnetic resonance imaging (MRI).

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 ClinicalTrials.gov identifier (NCT number): NCT03926273


Locations
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Egypt
Nageeb
Zagazig, El Sharkia, Egypt, 002
Sponsors and Collaborators
Zagazig University
Investigators
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Principal Investigator: nageeb rania, PI zagazig U

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Responsible Party: rania sanad, Principal Investigator, Zagazig University
ClinicalTrials.gov Identifier: NCT03926273     History of Changes
Other Study ID Numbers: ZU-IRB#5271\ 2-6-2018
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
Access Criteria: after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery
URL: http://ejnpn.springeropen.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by rania sanad, Zagazig University:
epilepsy
serum ghrelin
urine ghrelin

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases