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Lifestyle Changes in PCOS with OSA and NAFLD

Polycystic Ovarian Syndrome Women with NAFLD and Obstructive Sleeping Apnea: Program of Lifestyle Changes

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06591169
Enrollment
40
Registered
2024-09-19
Start date
2024-07-05
Completion date
2024-12-15
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD, OSA, PCOS

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,

Interventions

BEHAVIORALdiet 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

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
aspartate transamianseit will be assessed in serum after eight weeks

Secondary

MeasureTime frame
triglyceridesit will be assessed in serum after eight weeks
neck circumferenceit will be assessed after eight weeks
waist circumferenceit will be assessed after eight weeks
body mass indexit will be assessed after eight weeks
testesteroneit will be assessed in serum after eight weeks
alanine transaminaseit will be assessed in serum after eight weeks
apnea hyopnea indexit will be assessed after eight weeks
Epworth sleeping scaleit will be assessed after eight weeks
Dehydroepiandrosteroneit will be assessed in serum after eight weeks
waist hip ratioit will be assessed after eight weeks
ratio of luteinizing hormone and follicle-stimulating hormoneit will be assessed after eight weeks

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026