Clinical trial NCT06017726: Insulin Resistance in Egyptian Patients With Multiple Sclerosis
Official title: Insulin Resistance in Non-diabetic Multiple Sclerosis Patients: Prevalence, Pre and Post-treatment Effect on Clinical, Cognitive Profile, Laboratory, and Radiological Markers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Sclerosis
Insulin Resistance
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

Brief 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. what are the effects of insulin resistance on multiple sclerosis disease activity and progression
3. 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)

Eligibility criteria: 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:

* • 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.

Primary outcomes:
measure: prevalence of insulin resistance among Egyptians with multiple sclerosis
timeFrame: this will be determined in the first 2 months of the study (phase 1 of the study)
Secondary outcomes:
measure: effect of insulin resistance on Multiple sclerosis disease activity
timeFrame: this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)
measure: effect of insulin resistance on Multiple sclerosis disease progression
timeFrame: this evaluation will be done at 2 points; at the beginning and the end of the first year of the study (phase 2)
measure: effect of treating insulin resistance on Multiple sclerosis disease activity
timeFrame: this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)
measure: effect of treating insulin resistance on Multiple sclerosis disease progression
timeFrame: this evaluation will be done at 2 points; at the beginning and the end of the second year of the study (phase 3)
Other outcomes:
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