Insulin Resistance in Egyptian Patients With Multiple Sclerosis (IR-MS)
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ClinicalTrials.gov Identifier: NCT06017726 |
Recruitment Status :
Not yet recruiting
First Posted : August 30, 2023
Last Update Posted : August 30, 2023
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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
Condition or disease | Intervention/treatment |
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Multiple Sclerosis Insulin Resistance | Other: treatment of insulin resistance with appropriate modality according to each patient |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Insulin Resistance in Non-diabetic Multiple Sclerosis Patients: Prevalence, Pre and Post-treatment Effect on Clinical, Cognitive Profile, Laboratory, and Radiological Markers |
Estimated Study Start Date : | January 2024 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | June 2027 |
Group/Cohort | Intervention/treatment |
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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.
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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.
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Other: treatment of insulin resistance with appropriate modality according to each patient
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 |
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.
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- 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
- 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) ]disease activity (indicated by either annualized relapse rate or radiological activity) will be compared between MS patients with and without Insulin resistance
- 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) ]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
- 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) ]disease activity (indicated by either annualized relapse rate or radiological activity) will be compared between MS patients with treated and untreated Insulin resistance
- 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) ]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
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
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• 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.
Responsible Party: | doaa mokhtar mahmoud, lecturer, Assiut University |
ClinicalTrials.gov Identifier: | NCT06017726 |
Other Study ID Numbers: |
IR in Egyptian MS patients |
First Posted: | August 30, 2023 Key Record Dates |
Last Update Posted: | August 30, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Multiple Sclerosis Insulin Resistance Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases |
Autoimmune Diseases Immune System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs |