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Insulin Resistance in Egyptian Patients With Multiple Sclerosis

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 50 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06017726
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assiut University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis, Insulin Resistance

Additional Details

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)

Arms & Interventions

Arms

: 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.

: 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.

Interventions

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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