NCT07591246

Brief Summary

females of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress26%
Mar 2026Dec 2026

Study Start

First participant enrolled

March 7, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 9, 2026

Last Update Submit

May 9, 2026

Conditions

Non-Alcoholic Fatty Pancreatic DiseasePolycystic Ovary SyndromeSubclinical hypothyroïdism

Outcome Measures

Primary Outcomes (1)

  • Dehydroepiandrosterone

    it is a hormone involved in synthesis of sex hormones

    it will be measured after 6 months

Secondary Outcomes (14)

  • ratio of leutinzing hromone to hormone of follicels stimulatting hormones

    it will be measured after 6 months

  • testesterone

    it will be measured after 6 months

  • body mass index

    it will be measured after 6 months

  • waist circumference

    it will be measured after 6 months

  • blood gluocose

    it will be measured after 6 months

  • +9 more secondary outcomes

Study Arms (2)

group number 1

EXPERIMENTAL

twenty females of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)will be treated with daily dose of levothyroxine in addition to daily twotimes of 500-mg metformin, and these females will perform 50 minutes of aerobic treadmill walking hrice weekly for six month.

Behavioral: physical exercise program

group number 2

ACTIVE COMPARATOR

twenty females of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)will be treated with daily dose of levothyroxine in addition to daily twotimes of 500-mg metformin for six month

Other: usual care

Interventions

physical exercise programBEHAVIORAL

twenty females of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)will be treated with daily dose of levothyroxine in addition to daily twotimes of 500-mg metformin, and these females will perform 50 minutes of aerobic treadmill walking hrice weekly for six month.

group number 1
usual careOTHER

twenty females of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)will be treated with daily dose of levothyroxine in addition to daily two times of 500-mg metformin for six month.

group number 2

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS
  • fattty pancrease (non-alcoholic)
  • subclinical hypothyroid (signifcant with thyroid stimauted horomone more than 10 mIU/L) and normal non-disordered free thyroxine horomones

You may not qualify if:

  • cardiac disesase
  • renal diseases
  • respiratory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

ali mohamed

CONTACT

01031321109allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

May 9, 2026

First Posted

May 15, 2026

Study Start

March 7, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations

EG(1)