Actively Recruiting
Polycystic Ovarian Syndrome Women with NAFLD and Obstructive Sleeping Apnea: Program of Lifestyle Changes
Led by Cairo University · Updated on 2024-09-19
40
Participants Needed
2
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on obese women aged 30 to 40 years who have polycystic ovarian syndrome (PCOS), obstructive sleeping apnea (OSA), and fatty liver disease (NAFLD). The study aims to explore how lifestyle changes, along with medication, affect these conditions in women with these health challenges. The trial is randomized and single-blind, conducted by Cairo University to better understand treatment approaches for this group. Participants will be assigned to one of two groups of twenty obese women each. The study group will take metformin tablets three times daily, follow a low-calorie diet, and engage in daily 30-minute walking for eight weeks. The control group will also take metformin three times daily and follow the same low-calorie diet for eight weeks but without the walking exercise. These interventions are being evaluated to see their impact on liver health and related symptoms. Throughout the eight weeks, researchers will monitor various health measures including blood tests for liver enzymes and hormones, body measurements like neck and waist circumference, body mass index, and sleep quality assessments. The primary outcome is the level of aspartate transaminase in the blood after eight weeks. Secondary outcomes include other liver enzymes, lipid levels, hormone ratios, apnea index, and sleepiness scale. This comprehensive monitoring helps understand how these treatments affect the participants' overall health.
CONDITIONS
Brief Title
Lifestyle Changes in PCOS with OSA and NAFLD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants only
- Aged between 30 and 40 years
- Diagnosed with polycystic ovarian syndrome (PCOS)
- Diagnosed with obstructive sleep apnea (OSA)
- Obese women
- Complaints of fatty liver disease (NAFLD)
You will not qualify if you...
- History of cardiac insult
- History of renal insult
- Diagnosis of malignancy
- Currently pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive metformin tablets thrice daily combined with either a program of low diet intake and daily walking for 30 minutes or a program of low diet intake only for eight weeks.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 2 locations
1
faculty of physical therapy Cairo university
Dokki, Giza Governorate, Egypt
Actively Recruiting
2
faculty of physical therapy Cairo university
Dokki, Giza Governorate, Egypt
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here