Insulin Resistance in Egyptian Patients With Multiple Sclerosis (IR-MS)

• ClinicalTrials.gov Identifier: NCT06017726
• Recruitment Status: Not yet recruiting
• First Posted: August 30, 2023
• Last Update Posted: August 30, 2023
• Sponsor: Assiut University
• Information provided by (Responsible Party): doaa mokhtar mahmoud, Assiut University

Study Description

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

Condition or disease	Intervention/treatment
Multiple Sclerosis; Insulin Resistance	Other: treatment of insulin resistance with appropriate modality according to each patient

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

• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
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) ]
   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
3. 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
4. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• 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)

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• 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
• 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

Additional relevant MeSH terms:

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