ObesityNCT04417582
Life Style Modification Medical and Surgical Management in Patients With Obesity
An observational study of Obesity and Weight Change, Body, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
In this is an observational study, obese patients that administed and followed in endocrinology clinic of Marmara University Medical school hospital will follow for clinical and laboratory parameters prospectively for 5 years Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Weight Change, Body, Obesity; Endocrine
- What is being tested?
- bariatric surgey
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Dec 2025
- How long will I take part?
- 3 Years
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: obese patients refered to our tertiary center for obesity evaluation or treatment
Who may be able to join
- Body mass index over 30 kg/m2 age between 18-65 years
Who cannot join
- active malignancy pregnancy during involvement period chronic inflamatuar diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University Medical School Section of Endocrinology and Metabolism
Istanbul, 34899
Dilek Gogas Yavuz, MD, +902166254685, dilekgogas@marmara.edu.tr
Tuğçe Apaydın, MD
About this study
Official title: Evaluation of Life Style Modification Medical and Surgical Treatment Modalities in Patients With Obesity: An Observational Study
In this is an observational study, obese patients that administed and followed in endocrinology clinic of Marmara University Medical school hospital will follow for clinical and laboratory parameters prospectively for 5 years
Read the detailed description
Following available clinical and laboratory parameters will be collected for 5 years Treatment modalities ( life stye modification, medication, bariatric surgery) eating habits quality of life body mass index , blood pressure body fat distribution (impedance measurement) laboratory parameters (serum glucose, OGTT, insülin, lipids,creatinin ,ALT AST,CBC, ferritin calcium, phosphate, Parathormone,25 OH vitamin D, vitamin B12 ,uric acid, albumin, FSH LH testosteron, estrogen ) muscle strength (dynomometer measurement) skin glikolization autoflouresent measurement Bone mineral density mesurements (femur, spine ,forarm)
- Being tested
- bariatric surgey
- Keywords
- obesity, weight loss
- Medical subject headings
- Obesity, Body Weight Changes, Obesity, Metabolically Benign, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeyProcedure or surgery
Also called antiobesity drugs ,liraglutide or orlistat
patients undergone bariatric surgery or prescribed antiobesity drugs
| Study group | Role | What they receive |
|---|---|---|
| life syte modification only | obese patients followed with life style modification Receives: Procedure: bariatric surgey | |
| medical teatment with antiobesity drugs | patients prescribed antiobesity drugs Receives: Procedure: bariatric surgey | |
| bariatric surgery | patients undergone bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
%5-10 weight loss
Measured: 6 months interval
metabolic improvement
blood glucose
Measured: 6 months interval
metabolic improvement
serum lipid levels
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jan 2020
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2025 (estimated)
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.
- More trials run by Marmara 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417582
- Sponsor's protocol ID
- 09.2019.948
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: data will be shared at the second year of recruitment
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Life Style Modification Medical and Surgical Treatment Modalities in Patients With Obesity: An Observational Study
- ClinicalTrials.gov ID
- NCT04417582
- Acronym / sponsor ID
- 09.2019.948
- Keywords
- obesity, weight loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Jun 2020 (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.
In this is an observational study, obese patients that administed and followed in endocrinology clinic of Marmara University Medical school hospital will follow for clinical and laboratory parameters prospectively for 5 years
Detailed description
Following available clinical and laboratory parameters will be collected for 5 years Treatment modalities ( life stye modification, medication, bariatric surgery) eating habits quality of life body mass index , blood pressure body fat distribution (impedance measurement) laboratory parameters (serum glucose, OGTT, insülin, lipids,creatinin ,ALT AST,CBC, ferritin calcium, phosphate, Parathormone,25 OH vitamin D, vitamin B12 ,uric acid, albumin, FSH LH testosteron, estrogen ) muscle strength (dynomometer measurement) skin glikolization autoflouresent measurement Bone mineral density mesurements (femur, spine ,forarm)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| life syte modification only | – | Procedure: bariatric surgeyobese patients followed with life style modification |
| medical teatment with antiobesity drugs | – | Procedure: bariatric surgeypatients prescribed antiobesity drugs |
| bariatric surgery | – | –patients undergone bariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- obese patients refered to our tertiary center for obesity evaluation or treatment
Key inclusion criteria (1 listed)
- Body mass index over 30 kg/m2 age between 18-65 years
Key exclusion criteria (1 listed)
- active malignancy pregnancy during involvement period chronic inflamatuar diseases
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 |
|---|---|---|
| bariatric surgeyAlso: antiobesity drugs ,liraglutide or orlistatpatients undergone bariatric surgery or prescribed antiobesity drugs | Procedure or surgery | life syte modification only, medical teatment with antiobesity drugs |
Primary outcome
weight loss
Time frame: 6 months interval
%5-10 weight loss
metabolic improvement
Time frame: 6 months interval
blood glucose
metabolic improvement
Time frame: 6 month
serum lipid levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Undecided. data will be shared at the second year of recruitment
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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.
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 Weight Change, Body, run by Marmara 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 1 inclusion and 1 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 4 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dilek Gogas Yavuz, MD (+902166254685, dilekgogas@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 6 months interval). The study lists 3 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 4 Jun 2020.