Lifestyle Changes in PCOS with OSA and NAFLD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: diet restriction and exercise, diet restriction.
- Who it may be relevant to
- Registry conditions: PCOS, NAFLD, OSA. Basic parameters: 30 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Polycystic Ovarian Syndrome Women with NAFLD and Obstructive Sleeping Apnea: Program of Lifestyle Changes
Overview
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
- Behavioral 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 - 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
Primary outcome measures
- aspartate transamianse [Time frame: it will be assessed in serum after eight weeks]
Secondary outcome measures (11)
- alanine transaminase [Time frame: it will be assessed in serum after eight weeks]
- triglycerides [Time frame: it will be assessed in serum after eight weeks]
- neck circumference [Time frame: it will be assessed after eight weeks]
- waist circumference [Time frame: it will be assessed after eight weeks]
- body mass index [Time frame: it will be assessed after eight weeks]
- testesterone [Time frame: it will be assessed in serum after eight weeks]
- ratio of luteinizing hormone and follicle-stimulating hormone [Time frame: it will be assessed after eight weeks]
- apnea hyopnea index [Time frame: it will be assessed after eight weeks]
- Epworth sleeping scale [Time frame: it will be assessed after eight weeks]
- Dehydroepiandrosterone [Time frame: it will be assessed in serum after eight weeks]
- waist hip ratio [Time frame: it will be assessed after eight weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 2 centers
- faculty of physical therapy Cairo university — Dokki
- faculty of physical therapy Cairo university — Dokki
Identifiers
NCT: NCT06591169 · P.T.REC/012/005321