Lifestyle Changes in PCOS with OSA and NAFLD

Not Applicable

Recruiting

• Conditions: PCOS; NAFLD; OSA
• Interventions: Behavioral: diet restriction and exercise; Behavioral: diet restriction

• Registration Number: NCT06591169
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

Forty obese PCOS men with obstructive sleeping apnea and compaint of fatty liver will participate in this trial . Group (study group) will contain twenty obese females with a complaint of PCOS and OSA and fatty liver. for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake, and daily walking for 30 minutes. Group (control group) will contain twenty obese females with a complaint of PCOS and OSA and fatty liver . for eight weeks, these obese females will receive metformin tablet (thrice daily), program of low diet intake,

Study Timeline

• Study Start: 2024-07-05
• Status Verified: 2024-09
• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Last Update Submitted: 2024-09-09
• Study First Posted: 2024-09-11
• Last Update Posted: 2024-09-11
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• cardiac insult
• renal insult
• malignacy
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study	diet restriction and exercise	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
control group	diet restriction	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

Primary Outcome Measures

Name	Time	Method
aspartate transamianse	it will be assessed in serum after eight weeks

Secondary Outcome Measures

Name	Time	Method
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
testesterone	it will be assessed in serum after eight weeks
ratio of luteinizing hormone and follicle-stimulating hormone	it will be assessed after eight weeks
apnea hyopnea index	it will be assessed after eight weeks
Epworth sleeping scale	it will be assessed after eight weeks
Dehydroepiandrosterone	it will be assessed in serum after eight weeks
waist hip ratio	it will be assessed after eight weeks

Trial Locations

Locations (1)

faculty of physical therapy Cairo university; 🇪🇬 Dokki, Giza, Egypt