Severe Obesity Outcome Network Cohort (SOON)

Obesity Clinical Trial

— SOON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02264431
• Other study ID #: 1327
• Secondary ID: 2013-A01097-38
• Status: Recruiting
• Start date: January 2014
• Est. completion date: January 2024

Study information

• Verified date: January 2020
• Source: University Hospital, Grenoble
• Contact: Anne-Laure Borel, Pr MD PhD
• Phone: +33 476 765 509
• Email: alborel[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Obstructive Sleep Apnea
• Sleep
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble	Rhône-Alpes

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Act For Chronic Diseases, HP2 laboratory INSERM U1042, University Grenoble Alps

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Metabolic diseases	Evolution of metabolic diseases during obesity care, especially after bariatric surgery	5 years
Other	Other respiratory diseases	Evolution of other respiratory diseases during obesity care, especially after bariatric surgery	5 years
Other	Complications of bariatric surgery	Recording of complications after bariatric surgery	5 years
Primary	Sleep breathing disorders	Evolution of sleep breathing disorders during obesity management, especially after bariatric surgery	5 years
Secondary	Sleep habits	Evolution of sleep habits during obesity care, especially after bariatric surgery	5 years