ObesitySOONNCT02264431
Severe Obesity Outcome Network Cohort (SOON)
An observational study of Obesity and Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective of the study is to identify the determinant of sleep characteristics of obese patients attempting a tertiary clinical center for obesity management, including bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obstructive Sleep Apnea, Sleep
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jan 2024
- How long will I take part?
- 5 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with class II or class III obesity (Body mass index ≥ 35kg/m²)
Who may be able to join
- Class II or class III obesity (BMI ≥ 35 kg/m²). Only patients undergoing surgery to realize a second surgical line of management of their obesity may have a lower BMI, if the surgical recovery is motivated by a technical defect of the first assembly.
Who cannot join
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
Matthieu Lesgoirres contact
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble, Auvergne-Rhône-Alpes, 38043
Tiphaine Montagnon, +33 4 76 76 68 14, tmontagnon@chu-grenoble.fr
Matthieu Lesgoirres, mlesgoirres@chu-grenoble.fr
About this study
Official title: Determinants of Nocturnal Respiratory Disorders of Obese Patients Referred to in a Specialized Center.
The main objective of the study is to identify the determinant of sleep characteristics of obese patients attempting a tertiary clinical center for obesity management, including bariatric surgery.
More accurately the questions addressed are:
- What are the determinants of the sleep habits (sleep duration, chronotype) and of their evolution
- What are the determinants of sleep breathing disorders (sleep apnea, obesity hypoventilation syndrome) and of their evolution
Read the detailed description
Adult obese patients, attempting a tertiary medical center for the management of their obesity, are asked to participate in a cohort study. Data issued from routine clinical practice are collected.
Medical history and actual medical condition:
- Type 2 or type 1 diabetes
- Dyslipidemia
- Hypertension
- Cardiovascular diseases
- Steatohepatitis/cirrhosis
- Gastric disorders
- Nutritional deficiency
- Obstructive sleep apnea/Obesity hypoventilation syndrome
All patients who do not have a previously known sleep apnea syndrome are evaluated by nocturnal polygraphy.
Lifestyle and sleep habits, as well as social and economic characteristics, are assessed by questionnaires.
Patients are asked to provide blood sample to constituate a serum bank and gene bank.
Patients are asked, if undergoing bariatric surgery, to provide subcutaneous and visceral fat.
When patients benefit from bariatric surgery, follow-up data are collected at 3 months, 6 months, 12 months after bariatric surgery and yearly after that for at least 5 years.
- Conditions
- Obesity, Obstructive Sleep Apnea, Sleep
- Keywords
- Obesity, Obstructive Sleep Apnea, Sleep Habits, Bariatric Surgery, Cohort
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep breathing disorders
Evolution of sleep breathing disorders during obesity management, especially after bariatric surgery
Measured: 5 years
Secondary outcomes (1)
Sleep habits
Evolution of sleep habits during obesity care, especially after bariatric surgery
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Act For Chronic Diseases, HP2 laboratory INSERM U1042, University Grenoble Alps
- Responsible party
- Sponsor
- Investigators
- Anne-Laure Borel, Pr MD PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264431
- Sponsor's protocol ID
- 1327
- Other IDs
- 2013-A01097-38
- Acronym
- SOON
- Status last verified
- Jan 2020
- First submitted
- 8 Oct 2014
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borel AL, Van Ngo TH, Coumes S, Pepin JL, Abba J, Tamisier R, Tonetti G, Suzeau P, Reche F, Bailly S. Cluster analysis in subjects living with obesity and association with bariatric surgery outcomes: The severe obesity outcome network cohort. Clin Nutr. 2025 Nov;54:210-219. doi: 10.1016/j.clnu.2025.09.022. Epub 2025 Oct 4.
PubMed 41092584Guggino J, Coumes S, Wion N, Reche F, Arvieux C, Borel AL. Effectiveness and Safety of Bariatric Surgery in Patients with End-Stage Chronic Kidney Disease or Kidney Transplant. Obesity (Silver Spring). 2020 Dec;28(12):2290-2304. doi: 10.1002/oby.23001.
PubMed 33230959
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Nocturnal Respiratory Disorders of Obese Patients Referred to in a Specialized Center.
- ClinicalTrials.gov ID
- NCT02264431
- Acronym / sponsor ID
- SOON / 1327
- Conditions
- Obesity, Obstructive Sleep Apnea, Sleep
- Keywords
- Obesity, Obstructive Sleep Apnea, Sleep Habits, Bariatric Surgery, Cohort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Act For Chronic Diseases, HP2 laboratory INSERM U1042, University Grenoble Alps
- Study start
- Jan 2014
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 15 Oct 2014 (estimated)
- 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.
The main objective of the study is to identify the determinant of sleep characteristics of obese patients attempting a tertiary clinical center for obesity management, including bariatric surgery.
More accurately the questions addressed are:
- What are the determinants of the sleep habits (sleep duration, chronotype) and of their evolution
- What are the determinants of sleep breathing disorders (sleep apnea, obesity hypoventilation syndrome) and of their evolution
Detailed description
Adult obese patients, attempting a tertiary medical center for the management of their obesity, are asked to participate in a cohort study. Data issued from routine clinical practice are collected.
Medical history and actual medical condition:
- Type 2 or type 1 diabetes
- Dyslipidemia
- Hypertension
- Cardiovascular diseases
- Steatohepatitis/cirrhosis
- Gastric disorders
- Nutritional deficiency
- Obstructive sleep apnea/Obesity hypoventilation syndrome
All patients who do not have a previously known sleep apnea syndrome are evaluated by nocturnal polygraphy.
Lifestyle and sleep habits, as well as social and economic characteristics, are assessed by questionnaires.
Patients are asked to provide blood sample to constituate a serum bank and gene bank.
Patients are asked, if undergoing bariatric surgery, to provide subcutaneous and visceral fat.
When patients benefit from bariatric surgery, follow-up data are collected at 3 months, 6 months, 12 months after bariatric surgery and yearly after that for at least 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with class II or class III obesity (Body mass index ≥ 35kg/m²)
Key inclusion criteria (1 listed)
- Class II or class III obesity (BMI ≥ 35 kg/m²). Only patients undergoing surgery to realize a second surgical line of management of their obesity may have a lower BMI, if the surgical recovery is motivated by a technical defect of the first assembly.
Key exclusion criteria (1 listed)
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep breathing disorders
Time frame: 5 years
Evolution of sleep breathing disorders during obesity management, especially after bariatric surgery
1 secondary outcome
Sleep habits
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 41092584Borel AL, Van Ngo TH, Coumes S, Pepin JL, Abba J, Tamisier R, Tonetti G, Suzeau P, Reche F, Bailly S. Cluster analysis in subjects living with obesity and association with bariatric surgery outcomes: The severe obesity outcome network cohort. Clin Nutr. 2025 Nov;54:210-219. doi: 10.1016/j.clnu.2025.09.022. Epub 2025 Oct 4.
- Derived from this study: PubMed 33230959Guggino J, Coumes S, Wion N, Reche F, Arvieux C, Borel AL. Effectiveness and Safety of Bariatric Surgery in Patients with End-Stage Chronic Kidney Disease or Kidney Transplant. Obesity (Silver Spring). 2020 Dec;28(12):2290-2304. doi: 10.1002/oby.23001.
- 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.
Matthieu Lesgoirres contact
Anne-Laure Borel, Pr MD PhD principal investigator
University Hospital, Grenoble
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 University Hospital, Grenoble at 1 site in France.
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 27 Jan 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 France. 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 Anne-Laure Borel, Pr MD PhD (+33 476 765 509, alborel@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep breathing disorders (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02264431, which also lists 2 linked publications.
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 27 Jan 2020.