Insulin Resistance in Egyptian Patients With Multiple Sclerosis

Sponsor
Assiut University
Study ID
NCT06017726
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • treatment of insulin resistance with appropriate modality according to each patient — OTHER
    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 Details

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

Key Dates

First listed
Aug 30, 2023
Start date
Dec 31, 2024
Status verified
Jul 2024
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

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) ]

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