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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

Serum and Urine Ghrelin in Adult Epileptic Patients

Clinicaltrials.gov identifier NCT03926273

Recruitment Status Completed

First Posted April 24, 2019

Last update posted April 24, 2019

Study Description

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
  • Intervention/Treatment:
  • Phase: N/A
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).

Study Design
  • 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 2018
  • Actual Primary Completion Date: January 2019
  • Actual Study Completion Date: February 2019
Outcome Measures
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • 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).

Contacts and Locations
Contacts
Locations

Egypt, El Sharkia
Nageeb
Zagazig

Sponsors and Collaborators

Zagazig University

Investigators

Principal Investigator: nageeb rania, PI zagazig U

More Information
  • Responsible Party: 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Zagazig University: epilepsy
    serum ghrelin
    urine ghrelin
  • Additional relevant MeSH terms: Epilepsy