Multiple SclerosisNCT04210960
Correlation of Serum Lactate and Activity of Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Magentic resonanace imaging and Magentic resonanace spectroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Dec 2019to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 80 Egyptian subjects (50 multiple sclerosis patients (patients group = group I) and 30 normal healthy control (control group = group II)
Who may be able to join
- -Patients with multiple sclerosis (RRMS,PPMS and SPMS)
Who cannot join
- -Patients with any other medical conditions that may affect the serum lactate level
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
Esmael M Ahmed, MD, 00201000382898, deltaneuro@yahoo.com
About this study
Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS
Read the detailed description
Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS and magentic resonanace imaging , magentic resonanace spectroscopy
- Conditions
- Multiple Sclerosis
- Being tested
- Magentic resonanace imaging, Magentic resonanace spectroscopy
- Keywords
- Multiple sclerosis, serum lactate and MRS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magentic resonanace imagingRadiation
The brain MR imaging examinations were done by using a 3 tesla scanner (Acheiva; Philips Medical Systems, Best, Netherlands). All patients were examined in the supine position using head coil. Routine images (T2, T1, FLAIR) and double inversion recovery sequence (DIR) were done to all patients: repetition time (TR) _ 9583 sec, echo time (TE) _ 25 sec, inversion time (TI) _ 3400 sec, IR delay _ 325 sec, echo train length (ETL) _ 17, 50 contiguous axial slices, thickness _ 3 mm, matrix size 240× 142 mm2, field of view (FOV) 230× 184 mm2.
Magentic resonanace spectroscopyRadiation
Magnetic Resonance (MR) spectroscopy is a noninvasive diagnostic test for measuring biochemical changes in the brain.While magnetic resonance imaging (MRI) identifies the anatomical location of a lesion, MR spectroscopy compares the chemical composition of normal brain tissue with abnormal brain tissue. This test can also be used to detect tissue changes in stroke and epilepsy.
| Study group | Role | What they receive |
|---|---|---|
| Patients group | 50 multiple sclerosis patients Receives: Radiation: Magentic resonanace imaging; Radiation: Magentic resonanace spectroscopy | |
| Control group | 30 normal healthy control Receives: Radiation: Magentic resonanace imaging; Radiation: Magentic resonanace spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical testing
Plasma lactate was assayed according to Trinder method14 . All assays were carried out with Bechman Coulter AU480 autoanalyzer (USA).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start23 Dec 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael M Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210960
- Sponsor's protocol ID
- Mansoura University H 10
- Status last verified
- Dec 2019
- First submitted
- 22 Dec 2019
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Esmael A, Talaat M, Egila H, Eltoukhy K. Mitochondrial dysfunction and serum lactate as a biomarker for the progression and disability in MS and its correlation with the radiological findings. Neurol Res. 2021 Jul;43(7):582-590. doi: 10.1080/01616412.2021.1893567. Epub 2021 Mar 4.
PubMed 33657991
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Serum Lactate and Activity of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04210960
- Acronym / sponsor ID
- Mansoura University H 10
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, serum lactate and MRS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 26 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS
Detailed description
Correlation of serum lactate and activity of multiple sclerosis and its correlation to different type of MS and magentic resonanace imaging , magentic resonanace spectroscopy
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients group | – | Radiation: Magentic resonanace imaging, Radiation: Magentic resonanace spectroscopy50 multiple sclerosis patients |
| Control group | – | Radiation: Magentic resonanace imaging, Radiation: Magentic resonanace spectroscopy30 normal healthy control |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 80 Egyptian subjects (50 multiple sclerosis patients (patients group = group I) and 30 normal healthy control (control group = group II)
Key inclusion criteria (1 listed)
- -Patients with multiple sclerosis (RRMS,PPMS and SPMS)
Key exclusion criteria (1 listed)
- -Patients with any other medical conditions that may affect the serum lactate level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magentic resonanace imagingThe brain MR imaging examinations were done by using a 3 tesla scanner (Acheiva; Philips Medical Systems, Best, Netherlands). All patients were examined in the supine position using head coil. Routine images (T2, T1, FLAIR) and double inversion recovery sequence (DIR) were done to all patients: repetition time (TR) _ 9583 sec, echo time (TE) _ 25 sec, inversion time (TI) _ 3400 sec, IR delay _ 325 sec, echo train length (ETL) _ 17, 50 contiguous axial slices, thickness _ 3 mm, matrix size 240× 142 mm2, field of view (FOV) 230× 184 mm2. | Radiation | Control group, Patients group |
| Magentic resonanace spectroscopyMagnetic Resonance (MR) spectroscopy is a noninvasive diagnostic test for measuring biochemical changes in the brain.While magnetic resonance imaging (MRI) identifies the anatomical location of a lesion, MR spectroscopy compares the chemical composition of normal brain tissue with abnormal brain tissue. This test can also be used to detect tissue changes in stroke and epilepsy. | Radiation | Control group, Patients group |
Primary outcome
Biochemical testing
Time frame: 2 days
Plasma lactate was assayed according to Trinder method14 . All assays were carried out with Bechman Coulter AU480 autoanalyzer (USA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Derived from this study: PubMed 33657991Esmael A, Talaat M, Egila H, Eltoukhy K. Mitochondrial dysfunction and serum lactate as a biomarker for the progression and disability in MS and its correlation with the radiological findings. Neurol Res. 2021 Jul;43(7):582-590. doi: 10.1080/01616412.2021.1893567. Epub 2021 Mar 4.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esmael M Ahmed, MD principal investigator
Assistant Prof of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esmael M Ahmed, MD (00201000372787, deltaneuro@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical testing (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2019.