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Severe Obesity Outcome Network Cohort (SOON)

Determinants of Nocturnal Respiratory Disorders of Obese Patients Referred to in a Specialized Center.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02264431
Acronym
SOON
Enrollment
500
Registered
2014-10-15
Start date
2014-01-31
Completion date
2024-01-31
Last updated
2020-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Obstructive Sleep Apnea, Sleep

Keywords

Obesity, Obstructive Sleep Apnea, Sleep Habits, Bariatric Surgery, Cohort

Brief 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. 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.

Interventions

None listed

Sponsors

Act For Chronic Diseases
CollaboratorOTHER
HP2 laboratory INSERM U1042
CollaboratorUNKNOWN
University Grenoble Alps
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Refusal to participate.

Design outcomes

Primary

MeasureTime frameDescription
Sleep breathing disorders5 yearsEvolution of sleep breathing disorders during obesity management, especially after bariatric surgery

Secondary

MeasureTime frameDescription
Sleep habits5 yearsEvolution of sleep habits during obesity care, especially after bariatric surgery

Other

MeasureTime frameDescription
Metabolic diseases5 yearsEvolution of metabolic diseases during obesity care, especially after bariatric surgery
Other respiratory diseases5 yearsEvolution of other respiratory diseases during obesity care, especially after bariatric surgery
Complications of bariatric surgery5 yearsRecording of complications after bariatric surgery

Countries

France

Contacts

Primary ContactAnne-Laure Borel, Pr MD PhD
alborel@chu-grenoble.fr+33 476 765 509
Backup ContactMatthieu Lesgoirres
mlesgoirres@chu-grenoble.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026