NCT06591169

Brief Summary

Complain of obstructive sleeping apnea and fatty liver is common in PCOS women so lifestyle changes are recommended

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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 Start

First participant enrolled

July 5, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 9, 2024

Last Update Submit

September 9, 2024

Conditions

PCOSNAFLDOSA

Outcome Measures

Primary Outcomes (1)

  • aspartate transamianse

    it will be assessed in serum after eight weeks

Secondary Outcomes (11)

  • alanine transaminase

    it will be assessed in serum after eight weeks

  • triglycerides

    it will be assessed in serum after eight weeks

  • neck circumference

    it will be assessed after eight weeks

  • waist circumference

    it will be assessed after eight weeks

  • body mass index

    it will be assessed after eight weeks

  • +6 more secondary outcomes

Study Arms (2)

study

EXPERIMENTAL

this group will contain twenty obese females with a complaint of NAFLD, PCOS and OSA. for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake, and daily walking for 30 minutes

Behavioral: diet restriction and exercise

control group

ACTIVE COMPARATOR

this group will contain twenty obese females with a complaint of NAFLD, PCOS and OSA. for eight weeks, these obese females will receive metformin tablet (thrice daily) and program of low diet intake

Behavioral: diet restriction

Interventions

diet restriction and exerciseBEHAVIORAL

this group will contain twenty obese females with a complaint of NAFLD, PCOS and OSA. for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake, and daily walking for 30 minutes

study
diet restrictionBEHAVIORAL

this group will contain twenty obese females with a complaint of NAFLD, PCOS and OSA. for eight weeks, these obese females will receive metformin tablet (thrice daily) and program of low diet intake

control group

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsself-identified national gender ID
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • forty women
  • women complaint PCOS
  • women complain obstructive sleep apnea
  • women are obese
  • women complain fatty liver

You may not qualify if:

  • cardiac insult
  • renal insult
  • malignacy
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

RECRUITING

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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
Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt

Study Record Dates

First Submitted

September 9, 2024

First Posted

September 19, 2024

Study Start

July 5, 2024

Primary Completion

December 1, 2024

Study Completion

December 15, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

EG(2)