Severe Obesity Outcome Network Cohort (SOON)

  • STATUS
    Recruiting
  • End date
    Jan 24, 2024
  • participants needed
    500
  • sponsor
    University Hospital, Grenoble
Updated on 24 January 2021
hypoventilation
bariatric surgery
morbid obesity

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.

Details
Condition adiposity, Obesity, Obesity, Sleep, Obstructive sleep apnea, obstructive sleep apnoea, obstructive sleep apnea syndrome
Clinical Study IdentifierNCT02264431
SponsorUniversity Hospital, Grenoble
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Class II or class III obesity (BMI 35 kg/m). 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
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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