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出境医 / 临床实验 / Serum and Urine Ghrelin in Adult Epileptic Patients
Serum and Urine Ghrelin in Adult Epileptic Patients
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 |
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 1, 2018 |
| Actual Primary Completion Date : | January 30, 2019 |
| Actual Study Completion Date : | February 5, 2019 |
Arms and Interventions
| Group/Cohort |
|---|
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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.
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group 2
Control group consisted of 40 adults (16 females and 24 males) non - epileptic healthy subjects.
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Outcome Measures
Primary Outcome Measures :
- 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
- 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 |
| 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
Locations
| Egypt | |
| Nageeb | |
| Zagazig, El Sharkia, Egypt, 002 | |
Sponsors and Collaborators
Zagazig University
Investigators
| Principal Investigator: | nageeb rania, PI | zagazig U |
| Tracking Information | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | April 18, 2019 | ||||||||||||||
| First Posted Date | April 24, 2019 | ||||||||||||||
| Last Update Posted Date | April 24, 2019 | ||||||||||||||
| Actual Study Start Date | June 1, 2018 | ||||||||||||||
| Actual Primary Completion Date | January 30, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||||||||
| Change History | No Changes Posted | ||||||||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
| Descriptive Information | |||||||||||||||
| Brief Title | Serum and Urine Ghrelin in Adult Epileptic Patients | ||||||||||||||
| Official Title | Serum and Urine Ghrelin in Adult Epileptic Patients | ||||||||||||||
| 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). | ||||||||||||||
| Study Type | Observational | ||||||||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Other |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||
| Biospecimen | Not Provided | ||||||||||||||
| 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. | ||||||||||||||
| Condition | Epilepsy | ||||||||||||||
| Intervention | Not Provided | ||||||||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||
| Recruitment Status | Completed | ||||||||||||||
| Actual Enrollment |
80 | ||||||||||||||
| Original Actual Enrollment | Same as current | ||||||||||||||
| Actual Study Completion Date | February 5, 2019 | ||||||||||||||
| Actual Primary Completion Date | January 30, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||
| Listed Location Countries | Egypt | ||||||||||||||
| Removed Location Countries | |||||||||||||||
| Administrative Information | |||||||||||||||
| NCT Number | NCT03926273 | ||||||||||||||
| Other Study ID Numbers | ZU-IRB#5271\ 2-6-2018 | ||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | rania sanad, Zagazig University | ||||||||||||||
| Study Sponsor | Zagazig University | ||||||||||||||
| Collaborators | Not Provided | ||||||||||||||
| Investigators |
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| PRS Account | Zagazig University | ||||||||||||||
| Verification Date | April 2019 | ||||||||||||||
