Serum and Urine Ghrelin in Adult Epileptic Patients

April 22, 2019 updated by: rania sanad, Zagazig University
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Sharkia
      • Zagazig, El Sharkia, Egypt, 002
        • Nageeb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: nageeb rania, PI, zagazig U

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

February 5, 2019

Study Registration Dates

First Submitted

April 18, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2019

Last Update Submitted That Met QC Criteria

April 22, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZU-IRB#5271\ 2-6-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery

IPD Sharing Time Frame

after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery

IPD Sharing Access Criteria

after publishing the manuscript in the Egyptian journal of neurology, psychiatry and neurosurgery

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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