Serum and Urine Ghrelin in Adult Epileptic Patients | NCT03926273

Studies
Serum and Urine Ghrelin in Adult Epileptic Patients

NCT03926273

Sponsor

Zagazig University

Status

Completed

Last Update Posted

Apr 24, 2019Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Epilepsy

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Actual

Primary Completion Date

Jan 30, 2019Actual

Completion Date

Feb 5, 2019Actual

First Submitted Date

Apr 18, 2019

First Submission Date that Met QC Criteria

Apr 22, 2019

First Posted Date

Apr 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2019

Last Update Posted Date

Apr 24, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum ghrelin in Adult Epileptic Patients	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	evaluation of the effect of Urine ghrelin in adult epileptic patients and in their response to anti- epileptic drugs	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
nageeb rania, PI	zagazig U	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nageeb		Zagazig	Sharqia Province	002	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

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

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided