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CompletedNCT06416033Updated Nov 8, 2024

Serum Irisin Level In Leprosy Patients

An observational study in Leprosy, sponsored by Aswan University. Completed at 1 site in Egypt. Open to participants aged 15 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.

Sponsored by Aswan University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
58
Ages
15 Years to 80 Years
Sex
All
01

Study summary

  • Measurement of plasma irisin level in leprosy patients.
  • Correlation of plasma irisin level between leprosy patients and healthy controls.
  • Correlation of plasma irisin level in different leprosy types.
Read the detailed description

Leprosy is a chronic granulomatous infectious disease which infects mainly superficial peripheral nerves, mucosa of upper respiratory tract, testicles, bones, and eyes. It's an intracellular infection caused by the acid-fast bacillus, Mycobacterium leprae.

Both age and sex are important risk factors for leprosy infection, adolescents aged between 10 and 19 years and adults aged more than 30 years are more liable to leprosy, and the possibility of leprosy infection of adult males is twice as much as adult females.

Leprosy evolution involves complex host immune mechanisms that influence the clinical presentation of the disease . the spectral pathology of leprosy can be diagnosed by using two coexisting classification systems. The WHO classification system which is based on the number of lesions and Ridley and Jopling classification system which is based on the histopathology .

The WHO classification system includes individuals with more than five lesions which are classified as multibacillary (MB) patients, and individuals with less than five lesions which are classified as paucibacillary (PB) patients .While Ridley and Jopling classification system includes tuberculoid leprosy (TT), lepromatous leprosy (LL) and borderline phenotypes: {borderline tuberculoid (BT), mid-borderline (BB), and borderline lepromatous (BL).

Tuberculoid leprosy (TT) is characterized by the presence of one to three cutaneous lesions, called plaques. These lesions are circular or oval, erythematous/hypopigmented, hairless, scaly, dry and anesthetic. On the other hand, lepromatous leprosy (LL) is characterized by extensive and multiple bilateral lesions, which may include macules, papules, nodules, and plaques .

The majority of patients, however, present with the borderline phenotypes. In these phenotypes, the bacterial load correlates with the histological features, borderline tuberculoid (BT) being more closely related to tuberculoid leprosy( TT) patients while borderline lepromatous (BL) to lepromatous leprosy (LL) patients. The borderline states are immunologically unstable and susceptible to the occurrence of leprosy reactions.

In 1991 the World Health Assembly decided to 'eliminate leprosy as a public health problem' by the year 2000. Elimination was defined as decreasing the disease prevalence globally to less than 1 case per 10,000 populations. In 2000 the World Health Organization (WHO) announced that elimination was reached globally.

Irisin is a protein formed of 112 amino acids. It was discovered in 2012 at Harvard University. And named after an ancient Goddess called Iris, who served as a messenger among the Gods in Greek mythology.

Irisin has been linked to many metabolic diseases, including obesity, lipid metabolism ,cardiovascular disease (CVD), type 2 diabetes mellitus (T2DM) ,polycystic ovary syndrome (PCOS) ,Nonalcoholic fatty liver disease (NAFLD) and metabolic bone diseases .

02

Conditions studied

  • Leprosy

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Keywords

  • Leprosy
  • Irisin
  • tuberculoid leprosy
  • lepromatous leprosy
03

In context

Leprosy

52 studies on the registry are indexed under Leprosy; 13 are open to participants now.

Browse Leprosy studies →

Lead sponsor

Aswan University is the lead sponsor of 47 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Study will include patients with leprosy and healthy controls attending in the outpatient clinic of Dermatology, Venereology and Andrology, Aswan University Hospital, Aswan University.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • New cases of leprosy patients.

Exclusion criteria

Exclusion Criteria:

  • Old cases with leprosy.
  • Patients with cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM).
  • Patients with polycystic ovary syndrome (PCOS), Nonalcoholic fatty liver disease (NAFLD) and metabolic bone diseases.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
58 participants (actual)
Patient registry
No

Groups and cohorts

  • Group A :(Leprosy Group)

    About 29 patients newly affected with Leprosy and The plasma irisin level of the participants will be measured by enzyme-linked immunosorbent assay (ELISA).

    Procedure: Serum Irisin

  • Group B:(Control Group)

    About 29 apparently healthy individuals and The plasma irisin level of the participants will be measured by enzyme-linked immunosorbent assay (ELISA).

    Procedure: Serum Irisin

Interventions

  • ProcedureSerum Irisin

    Measurement of plasma irisin level in leprosy patients.

06

What researchers measure

Primary outcomes

  1. measurement of Serum Irisin

    comparing the plasma irisin levels in leprosy patients with healthy Participants

    Time frame: 24 hours

07

Study locations

1 site
  • Aswan University Hospital
    Aswan, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06416033
Lead sponsor
Aswan University
Responsible party
Esraa Nagy Zaki Faheem (Resident at Dermatology, Venereology and Andrology, Aswan University) — Principal investigator
First posted
May 16, 2024
Start date
Jan 1, 2024
Primary completion
Jul 1, 2024
Completion
Jul 15, 2024
Last update
Nov 8, 2024

Study contacts

Moustafa El Taieb, Professor
study chair · Department of Dermatology, Venereology and Andrology Faculty of Medicine, Aswan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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