Actively Recruiting

Phase Not Applicable
Age: 30Years - 40Years
FEMALE
ID06591169

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

Age: 30Years - 40Years
FEMALE

Eligibility Criteria

Eligible

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)
Not Eligible

You will not qualify if you...

  • History of cardiac insult
  • History of renal insult
  • Diagnosis of malignancy
  • Currently pregnant

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

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

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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