ObesityNCT07029750
Long-term Effects of Lipoabdominoplasty on Pulmonary Function and Sleep Apnea Risk in Obese Subjects
An observational study of Obesity and Obstructive Sleep Apnea, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the long-term effects of lipoabdominoplasty on pulmonary function and obstructive sleep apnea (OSA) risk in obese patients. Participants were evaluated before and three months after surgery using spirometry, mMRC dyspnea scores, Epworth Sleepiness Scale (ESS), and STOP-Bang questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obstructive Sleep Apnea
- What is being tested?
- Lipoabdominoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Jan 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective observational study will include adult patients (18-65 years) with a body mass index (BMI) over 30 kg/m² who are scheduled to undergo lipoabdominoplasty at a single tertiary care center. Eligible participants will be evaluated prior to surgery and again at 3 months postoperatively. Individuals with active pulmonary infections, chronic lung diseases, recent additional surgeries, or pregnancy will be excluded. All participants will provide written informed consent before enrollment. Approximately 24 participants are expected to complete both baseline and follow-up assessments.
Who may be able to join
- Age ≥ 18 years
- BMI ≥ 30 kg/m²
- Eligible for lipoabdominoplasty
- Voluntary informed consent
Who cannot join
- Pregnancy
- Active respiratory tract infections
- Additional surgical interventions during study period
- Refusal to participate or incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the long-term effects of lipoabdominoplasty on pulmonary function and obstructive sleep apnea (OSA) risk in obese patients. Participants were evaluated before and three months after surgery using spirometry, mMRC dyspnea scores, Epworth Sleepiness Scale (ESS), and STOP-Bang questionnaires.
- Conditions
- Obesity, Obstructive Sleep Apnea
- Being tested
- Lipoabdominoplasty
- Keywords
- Obesity, Obstructive Sleep Apnea, Pulmonary Function, Lipoabdominoplasty
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipoabdominoplastyProcedure or surgery
Combination of liposuction and abdominoplasty under general anesthesia. Klein solution used for tumescent liposuction. Muscle plication performed with 0 loop polydioxanone suture. Umbilicus preserved and repositioned. Postoperative compression corset used for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Obese subjects undergoing lipoabdominoplasty Receives: Procedure: Lipoabdominoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8-10 minutes
Forced Expiratory Volume in 1 second (FEV1)
Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8-10 minutes
Peak Expiratory Flow (PEF)
Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8-10 minutes
Forced Expiratory Flow 25-75% (FEF25-75)
Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.
Measured: 8-10 minutes
mMRC Dyspnea Score
The dyspnea score will be assessed with the mMRC dyspnea score and is based on five stages of dyspnea caused by exertion and is scored between 0-4.
Measured: 8-10 minutes
Sleep Apnea Risk Score
Sleep apnoea risk will be assessed using the Epworth Sleepiness Scale (ESS), a validated 8-item questionnaire that measures the subject's likelihood of falling asleep during daily activities. Higher scores reflect greater levels of daytime sleepiness and increased risk for conditions such as obstructive sleep apnoea.
Measured: 8-10 minutes
Obstructive Sleep Apnea Risk Score
Obstructive sleep apnoea risk will be assessed assessed using the STOP-Bang questionnaire, an eight-item screening tool that evaluates snoring, tiredness, observed apnoea, high blood pressure, BMI, age, neck circumference, and gender. A higher score indicates a greater risk of OSA, with a cut-off of ≥3 commonly used to identify high-risk individuals.
Measured: 8-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start1 Jul 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University
- Responsible party
- Principal investigator, Hikmet Ucgun, Atlas University
- Investigators
- Hikmet Ucgun, PT, PhD, Principal investigator, Atlas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029750
- Sponsor's protocol ID
- auhucgun05
- Status last verified
- Oct 2026
- First submitted
- 12 Jun 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Lipoabdominoplasty on Pulmonary Function and Sleep Apnea Risk in Obese Subjects
- ClinicalTrials.gov ID
- NCT07029750
- Acronym / sponsor ID
- auhucgun05
- Conditions
- Obesity, Obstructive Sleep Apnea
- Keywords
- Obesity, Obstructive Sleep Apnea, Pulmonary Function, Lipoabdominoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Collaborators
- Medipol University
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 19 Jun 2025 (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.
This study investigates the long-term effects of lipoabdominoplasty on pulmonary function and obstructive sleep apnea (OSA) risk in obese patients. Participants were evaluated before and three months after surgery using spirometry, mMRC dyspnea scores, Epworth Sleepiness Scale (ESS), and STOP-Bang questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Procedure: LipoabdominoplastyObese subjects undergoing lipoabdominoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective observational study will include adult patients (18-65 years) with a body mass index (BMI) over 30 kg/m² who are scheduled to undergo lipoabdominoplasty at a single tertiary care center. Eligible participants will be evaluated prior to surgery and again at 3 months postoperatively. Individuals with active pulmonary infections, chronic lung diseases, recent additional surgeries, or pregnancy will be excluded. All participants will provide written informed consent before enrollment. Approximately 24 participants are expected to complete both baseline and follow-up assessments.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- BMI ≥ 30 kg/m²
- Eligible for lipoabdominoplasty
- Voluntary informed consent
Key exclusion criteria (4 listed)
- Pregnancy
- Active respiratory tract infections
- Additional surgical interventions during study period
- Refusal to participate or incomplete data
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 |
|---|---|---|
| LipoabdominoplastyCombination of liposuction and abdominoplasty under general anesthesia. Klein solution used for tumescent liposuction. Muscle plication performed with 0 loop polydioxanone suture. Umbilicus preserved and repositioned. Postoperative compression corset used for 1 month. | Procedure or surgery | Participants |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: 8-10 minutes
Forced Vital Capacity will be measured before six-minute walk test according to the guideline of ERS.
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 8-10 minutes
Forced Expiratory Volume in 1 second will be measured before six-minute walk test according to the guideline of ERS.
Peak Expiratory Flow (PEF)
Time frame: 8-10 minutes
Peak Expiratory Flow will be measured before six-minute walk test according to the guideline of ERS.
Forced Expiratory Flow 25-75% (FEF25-75)
Time frame: 8-10 minutes
Forced Expiratory Flow 25-75% will be measured before six-minute walk test according to the guideline of ERS.
mMRC Dyspnea Score
Time frame: 8-10 minutes
The dyspnea score will be assessed with the mMRC dyspnea score and is based on five stages of dyspnea caused by exertion and is scored between 0-4.
Sleep Apnea Risk Score
Time frame: 8-10 minutes
Sleep apnoea risk will be assessed using the Epworth Sleepiness Scale (ESS), a validated 8-item questionnaire that measures the subject's likelihood of falling asleep during daily activities. Higher scores reflect greater levels of daytime sleepiness and increased risk for conditions such as obstructive sleep apnoea.
Obstructive Sleep Apnea Risk Score
Time frame: 8-10 minutes
Obstructive sleep apnoea risk will be assessed assessed using the STOP-Bang questionnaire, an eight-item screening tool that evaluates snoring, tiredness, observed apnoea, high blood pressure, BMI, age, neck circumference, and gender. A higher score indicates a greater risk of OSA, with a cut-off of ≥3 commonly used to identify high-risk individuals.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Hikmet Ucgun, PT, PhD principal investigator
Atlas University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obstructive Sleep Apnea, run by Atlas University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity (FVC) (time frame: 8-10 minutes). The study lists 7 primary outcomes in all. 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 15 Oct 2026.