Clinical trial NCT02264431: Severe Obesity Outcome Network Cohort (SOON)
Official title: Determinants of Nocturnal Respiratory Disorders of Obese Patients Referred to in a Specialized Center.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Obstructive Sleep Apnea
Sleep
Keywords: Obesity
Obstructive Sleep Apnea
Sleep Habits
Bariatric Surgery
Cohort
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Act For Chronic Diseases
name: HP2 laboratory INSERM U1042
name: University Grenoble Alps
First posted: 2014-10-15
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with class II or class III obesity (Body mass index ≥ 35kg/m²)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep breathing disorders
timeFrame: 5 years
Secondary outcomes:
measure: Sleep habits
timeFrame: 5 years
Other outcomes:
measure: Metabolic diseases
timeFrame: 5 years
measure: Other respiratory diseases
timeFrame: 5 years
measure: Complications of bariatric surgery
timeFrame: 5 years
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
state: Rhône-Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Anne-Laure Borel, Pr MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guggino 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.