Severe Obesity Outcome Network Cohort (SOON)

NCT02264431 | Unknown

• 2 other identifiers: 13272013-A01097-38
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity; Obstructive Sleep Apnea; Sleep

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Sleep breathing disorders

  Evolution of sleep breathing disorders during obesity management, especially after bariatric surgery

  5 years

Secondary Outcomes (1)

• Sleep habits

  5 years

Other Outcomes (3)

• Metabolic diseases

  5 years

• Other respiratory diseases

  5 years

• Complications of bariatric surgery

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with class II or class III obesity (Body mass index ≥ 35kg/m²)

You may qualify if:

• 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.

You may not qualify if:

• Refusal to participate.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Act For Chronic Diseases: collaborator
• HP2 laboratory INSERM U1042: collaborator
• University Grenoble Alps: collaborator

Study Sites (1)

Grenoble University Hospital

Grenoble, Auvergne-Rhône-Alpes, 38043, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 41092584 DERIVED

• 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.

  PMID: 33230959 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum bank, gene bank, tissue bank (subcutaneous fat, visceral fat)

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Anne-Laure Borel, Pr MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Laure Borel, Pr MD PhD

CONTACT

+33 476 765 509; alborel@chu-grenoble.fr

Matthieu Lesgoirres

CONTACT

mlesgoirres@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 15, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)