PCOSNCT06591169
Lifestyle Changes in PCOS with OSA and NAFLD
A study testing diet restriction and exercise and diet restriction in people with PCOS and NAFLD, run by Cairo University at 2 sites in Egypt.
Trial summary
Complain of obstructive sleeping apnea and fatty liver is common in PCOS women so lifestyle changes are recommended Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- What is being tested?
- diet restriction and exercise and diet restriction
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 Jul 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- forty women
- women complaint PCOS
- women complain obstructive sleep apnea
- women are obese
- women complain fatty liver
Who cannot join
- cardiac insult
- renal insult
- malignacy
- pregnancy
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
faculty of physical therapy Cairo university
Dokki, Giza Governorate
Ali MA Ismail, lecturer, +0201005154209, ali.mohamed@pt.cu.edu.eg
Dina MA Mohamed, lecturer, +2 01068745636, Dina_Mahmoud@cu.edu.eg
- Recruiting
faculty of physical therapy Cairo university
Dokki, Giza Governorate
Ali Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
Dina MA Mohamed, lecturer, +2 01068745636, Dina_Mahmoud@cu.edu.eg
About this study
Official title: Polycystic Ovarian Syndrome Women with NAFLD and Obstructive Sleeping Apnea: Program of Lifestyle Changes
Complain of obstructive sleeping apnea and fatty liver is common in PCOS women so lifestyle changes are recommended
Read the 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,
- Being tested
- diet restriction and exercise, diet restriction
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet restriction and exerciseBehavioural
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
diet restrictionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| study | Experimental | 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 Receives: Behavioral: diet restriction and exercise |
| control group | Active comparator | 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 Receives: Behavioral: diet restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
aspartate transamianse
Measured: it will be assessed in serum after eight weeks
Secondary outcomes (11)
alanine transaminase
Measured: it will be assessed in serum after eight weeks
triglycerides
Measured: it will be assessed in serum after eight weeks
neck circumference
Measured: it will be assessed after eight weeks
waist circumference
Measured: it will be assessed after eight weeks
body mass index
Measured: it will be assessed after eight weeks
testesterone
Measured: it will be assessed in serum after eight weeks
ratio of luteinizing hormone and follicle-stimulating hormone
Measured: it will be assessed after eight weeks
apnea hyopnea index
Measured: it will be assessed after eight weeks
Epworth sleeping scale
Measured: it will be assessed after eight weeks
Dehydroepiandrosterone
Measured: it will be assessed in serum after eight weeks
waist hip ratio
Measured: it will be assessed after eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Jul 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591169
- Sponsor's protocol ID
- P.T.REC/012/005321
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polycystic Ovarian Syndrome Women with NAFLD and Obstructive Sleeping Apnea: Program of Lifestyle Changes
- ClinicalTrials.gov ID
- NCT06591169
- Acronym / sponsor ID
- P.T.REC/012/005321
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | Experimental | Behavioral: diet restriction and exercisethis 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 | Active comparator | Behavioral: diet restrictionthis 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 |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- forty women
- women complaint PCOS
- women complain obstructive sleep apnea
- women are obese
- women complain fatty liver
Key exclusion criteria (4 listed)
- cardiac insult
- renal insult
- malignacy
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diet restriction and exercisethis 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 | Behavioural | study |
| diet restrictionthis 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 | Behavioural | control group |
Primary outcome
aspartate transamianse
Time frame: it will be assessed in serum after eight weeks
11 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Related trials for PCOS
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet restriction and exercise and diet restriction in people with PCOS and NAFLD, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aspartate transamianse (time frame: it will be assessed in serum after eight weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.