NCT06416033

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

November 8, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

May 10, 2024

Last Update Submit

November 7, 2024

Conditions

Keywords

LeprosyIrisintuberculoid leprosylepromatous leprosy

Outcome Measures

Primary Outcomes (1)

  • measurement of Serum Irisin

    comparing the plasma irisin levels in leprosy patients with healthy Participants

    24 hours

Study Arms (2)

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

Serum IrisinPROCEDURE

Measurement of plasma irisin level in leprosy patients.

Group A :(Leprosy Group)Group B:(Control Group)

Eligibility Criteria

Age15 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- New cases of leprosy patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

Location

MeSH Terms

Conditions

LeprosyLeprosy, TuberculoidLeprosy, Lepromatous

Condition Hierarchy (Ancestors)

Mycobacterium Infections, NontuberculousMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLeprosy, PaucibacillaryLeprosy, Multibacillary

Study Officials

  • Moustafa El Taieb, Professor

    Department of Dermatology, Venereology and Andrology Faculty of Medicine, Aswan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Dermatology, Venereology and Andrology

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 16, 2024

Study Start

January 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 15, 2024

Last Updated

November 8, 2024

Record last verified: 2024-05

Locations