Multiple SclerosisIR-MSNCT06017726
Insulin Resistance in Egyptian Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis and Insulin Resistance, run by Assiut University.
Trial summary
The goal of this three-phase interventional study is to determine the prevalence of Insulin resistance in non-diabetic patients with multiple sclerosis in Egypt The main questions it aims to answer are: 1. what is the prevalence of insult resistance among Egyptian patients with Multiple sclerosis? 2. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Insulin Resistance
- What is being tested?
- treatment of insulin resistance with appropriate modality according to each patient
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 50 years
- All sexes
- Adult
Study population: multiple sclerosis patients diagnosed according to the revised McDonald's Criteria for diagnosis of multiple sclerosis 2017 of different phenotypes (relapsing-remitting, primary progressive, and secondary progressive)
Who may be able to join
- seventy patients aged 18-50 years old of both sex fulfilling the revised McDonald's Criteria for diagnosis of multiple sclerosis 2017 of different phenotypes (relapsing-remitting, primary progressive, and secondary progressive), will be recruited during their follow-up visits to our MS unit.
Who cannot join
- • Recent MS relapse or use of corticosteroids in the past 3 months
- patients with a systemic disease like diabetes mellitus, hypertension, cardiac disease, liver or renal disease or alcoholic patients
- patients who are on a specific diet.
- patients using any anti-inflammatory drugs, cholesterol-lowering agents, estrogen replacement therapy, steroid therapy or other drugs that could affect the metabolic profile.
- Patients with non-MS demyelinating disorders like NMOSD and MOGAD.
- Patients who failed to commit to regular follow-ups.
About this study
Official title: Insulin Resistance in Non-diabetic Multiple Sclerosis Patients: Prevalence, Pre and Post-treatment Effect on Clinical, Cognitive Profile, Laboratory, and Radiological Markers
The goal of this three-phase interventional study is to determine the prevalence of Insulin resistance in non-diabetic patients with multiple sclerosis in Egypt
The main questions it aims to answer are:
- what is the prevalence of insult resistance among Egyptian patients with Multiple sclerosis?
- what are the effects of insulin resistance on multiple sclerosis disease activity and progression
- what are the effects of treating insulin resistance on multiple sclerosis disease activity and progression participants with MS will be tested for IR to determine its prevalence, in the 2nd phase a group of MS patients with IR will be compared with another control group of MS patients without IR for clinical, laboratory, and radiological markers of disease activity and progression twice at baseline and after 1 year. in the 3rd phase, patients with IR will be divided into 2 groups one who will receive appropriate treatment for IR and the other group without treatment of IR and will be compared by the end of the 2nd year for clinical, laboratory and radiological markers of disease activity and progression
Read the detailed description
In this longitudinal, three-phase, case-control, interventional study, with 250 patients with multiple sclerosis diagnosed according to the 2017 McDonald's criteria will be enrolled. Frist diagnosis of cases of insulin resistant MS patient out of the total sample of MS through estimation of fasting blood glucose, insulin level, and homeostatic model assessment of insulin resistance (HOMA-IR) index. Other supportive indices like waste circumference, hemoglobin A1c, and lipid profile will be used. At the end of first phase, prevalence of IR and associated metabolic syndrome will be determined. In the second phase of the study, patients will be divided into two groups with and without IR. Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. Diffusion tensor imaging with a fully automated too (volbrain) will be used. Patients in the second phase of the study will be evaluated both at baseline and after one year. In the third phase, patients with IR will be divided randomly into two equal groups (1:1) using closed envelope: intervention group who will receive appropriate treatment for IR and a control group with placebo treatment (without IR treatment) and by the end of the second year all groups will be evaluated blindly using the same evaluating measures (clinical, laboratory and radiological)
- Conditions
- Multiple Sclerosis, Insulin Resistance
- Being tested
- treatment of insulin resistance with appropriate modality according to each patient
- Medical subject headings
- Multiple Sclerosis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment of insulin resistance with appropriate modality according to each patientOther
insulin resistance will be treated with either diet alone or combined diet and appropriate pharmacological treatment with the net result of normalization of HOMA IR index
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis patients without insulin resistance | Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging. | |
| Multiple sclerosis patients with treated insulin resistance | before and after treatment of insulin resistance Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging. Receives: Other: treatment of insulin resistance with appropriate modality according to each patient | |
| Multiple sclerosis patients with untreated insulin resistance | at the end of the 1st and 2nd year of the study, Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of insulin resistance among Egyptians with multiple sclerosis
to determine the prevalence of Insulin resistance among Egyptian patients with multiple sclerosis using the homeostatic model assessment of insulin resistance (HOMA-IR) index
Measured: this will be determined in the first 2 months of the study (phase 1 of the study)
Secondary outcomes (4)
effect of insulin resistance on Multiple sclerosis disease activity
disease activity (indicated by either annualized relapse rate or radiological activity) will be compared between MS patients with and without Insulin resistance
Measured: this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)
effect of insulin resistance on Multiple sclerosis disease progression
disease progression (indicated by either changes in BICAMS scores, or radiological markers of progression) will be compared between MS patients with and without Insulin resistance
Measured: this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)
effect of treating insulin resistance on Multiple sclerosis disease activity
disease activity (indicated by either annualized relapse rate or radiological activity) will be compared between MS patients with treated and untreated Insulin resistance
Measured: this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)
effect of treating insulin resistance on Multiple sclerosis disease progression
disease progression (indicated by either changes in BICAMS scores or radiological markers of progression) will be compared between MS patients with treated and untreated Insulin resistance
Measured: this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study startDec 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, doaa mokhtar mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017726
- Sponsor's protocol ID
- IR in Egyptian MS patients
- Acronym
- IR-MS
- Status last verified
- Jul 2024
- First submitted
- 18 Aug 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance in Non-diabetic Multiple Sclerosis Patients: Prevalence, Pre and Post-treatment Effect on Clinical, Cognitive Profile, Laboratory, and Radiological Markers
- ClinicalTrials.gov ID
- NCT06017726
- Acronym / sponsor ID
- IR-MS / IR in Egyptian MS patients
- Conditions
- Multiple Sclerosis, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 30 Aug 2023 (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.
The goal of this three-phase interventional study is to determine the prevalence of Insulin resistance in non-diabetic patients with multiple sclerosis in Egypt
The main questions it aims to answer are:
- what is the prevalence of insult resistance among Egyptian patients with Multiple sclerosis?
- what are the effects of insulin resistance on multiple sclerosis disease activity and progression
- what are the effects of treating insulin resistance on multiple sclerosis disease activity and progression participants with MS will be tested for IR to determine its prevalence, in the 2nd phase a group of MS patients with IR will be compared with another control group of MS patients without IR for clinical, laboratory, and radiological markers of disease activity and progression twice at baseline and after 1 year. in the 3rd phase, patients with IR will be divided into 2 groups one who will receive appropriate treatment for IR and the other group without treatment of IR and will be compared by the end of the 2nd year for clinical, laboratory and radiological markers of disease activity and progression
Detailed description
In this longitudinal, three-phase, case-control, interventional study, with 250 patients with multiple sclerosis diagnosed according to the 2017 McDonald's criteria will be enrolled. Frist diagnosis of cases of insulin resistant MS patient out of the total sample of MS through estimation of fasting blood glucose, insulin level, and homeostatic model assessment of insulin resistance (HOMA-IR) index. Other supportive indices like waste circumference, hemoglobin A1c, and lipid profile will be used. At the end of first phase, prevalence of IR and associated metabolic syndrome will be determined. In the second phase of the study, patients will be divided into two groups with and without IR. Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. Diffusion tensor imaging with a fully automated too (volbrain) will be used. Patients in the second phase of the study will be evaluated both at baseline and after one year. In the third phase, patients with IR will be divided randomly into two equal groups (1:1) using closed envelope: intervention group who will receive appropriate treatment for IR and a control group with placebo treatment (without IR treatment) and by the end of the second year all groups will be evaluated blindly using the same evaluating measures (clinical, laboratory and radiological)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis patients without insulin resistance | – | –Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging. |
| Multiple sclerosis patients with treated insulin resistance | – | Other: treatment of insulin resistance with appropriate modality according to each patientbefore and after treatment of insulin resistance Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging. |
| Multiple sclerosis patients with untreated insulin resistance | – | –at the end of the 1st and 2nd year of the study, Cognitive status will be evaluated with BICAMS test. Physical disability will be evaluated by the EDSS score, 9-hole pig and 25-foot-walk test. Patients will be assessed for other comorbid conditions like fatigue and depression. Serum light chain neurofilaments as a laboratory marker for axonal degeneration will be used. brain imaging will be done with with Diffusion tensor imaging. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- multiple sclerosis patients diagnosed according to the revised McDonald's Criteria for diagnosis of multiple sclerosis 2017 of different phenotypes (relapsing-remitting, primary progressive, and secondary progressive)
Key inclusion criteria (1 listed)
- seventy patients aged 18-50 years old of both sex fulfilling the revised McDonald's Criteria for diagnosis of multiple sclerosis 2017 of different phenotypes (relapsing-remitting, primary progressive, and secondary progressive), will be recruited during their follow-up visits to our MS unit.
Key exclusion criteria (6 listed)
- • Recent MS relapse or use of corticosteroids in the past 3 months
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 |
|---|---|---|
| treatment of insulin resistance with appropriate modality according to each patientinsulin resistance will be treated with either diet alone or combined diet and appropriate pharmacological treatment with the net result of normalization of HOMA IR index | Other | Multiple sclerosis patients with treated insulin resistance |
Primary outcome
prevalence of insulin resistance among Egyptians with multiple sclerosis
Time frame: this will be determined in the first 2 months of the study (phase 1 of the study)
to determine the prevalence of Insulin resistance among Egyptian patients with multiple sclerosis using the homeostatic model assessment of insulin resistance (HOMA-IR) index
4 secondary outcomes
effect of insulin resistance on Multiple sclerosis disease activity
Time frame: this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)
effect of insulin resistance on Multiple sclerosis disease progression
Time frame: this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)
effect of treating insulin resistance on Multiple sclerosis disease activity
Time frame: this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)
effect of treating insulin resistance on Multiple sclerosis disease progression
Time frame: this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Insulin Resistance, run by Assiut University.
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 6 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: opening soon, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of insulin resistance among Egyptians with multiple sclerosis (time frame: this will be determined in the first 2 months of the study (phase 1 of the study)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2024.