Lifestyle Changes in PCOS with OSA and NAFLD

NCT ID: NCT06591169

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-05

Study Completion Date

2024-12-15

Brief Summary

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

Detailed Description

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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,

Conditions

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PCOS NAFLD OSA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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study

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

Group Type EXPERIMENTAL

diet restriction and exercise

Intervention Type BEHAVIORAL

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

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

Group Type ACTIVE_COMPARATOR

diet restriction

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

Site Status RECRUITING

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ali MA Ismail, lecturer

Role: primary

+0201005154209

Dina MA Mohamed, lecturer

Role: backup

+2 01068745636

Ali Ismail, lecturer

Role: primary

+201005154209

Dina MA Mohamed, lecturer

Role: backup

+2 01068745636

Ali MA Ismail, Lecturer

Role: backup

Other Identifiers

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P.T.REC/012/005321

Identifier Type: -

Identifier Source: org_study_id

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