Severe Obesity Outcome Network Cohort (SOON) (SOON)

January 24, 2020 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Rhône-Alpes
      • Grenoble, Rhône-Alpes, France, 38043
        • Recruiting
        • Grenoble University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anne-Laure Borel, Pr MD PhD
        • Sub-Investigator:
          • Catherine Arvieux, Pr MD PhD
        • Sub-Investigator:
          • Nelly Wion, MD PhD
        • Sub-Investigator:
          • Sandrine Coumes, MD PhD
        • Sub-Investigator:
          • Jean-Pierre Zarski, Pr MD PhD
        • Sub-Investigator:
          • Marie-Noëlle Hilleret, MD PhD
        • Sub-Investigator:
          • Jean-Christian Borel, MD PhD
        • Sub-Investigator:
          • Olivier Ormezzano, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep breathing disorders
Time Frame: 5 years
Evolution of sleep breathing disorders during obesity management, especially after bariatric surgery
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep habits
Time Frame: 5 years
Evolution of sleep habits during obesity care, especially after bariatric surgery
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic diseases
Time Frame: 5 years
Evolution of metabolic diseases during obesity care, especially after bariatric surgery
5 years
Other respiratory diseases
Time Frame: 5 years
Evolution of other respiratory diseases during obesity care, especially after bariatric surgery
5 years
Complications of bariatric surgery
Time Frame: 5 years
Recording of complications after bariatric surgery
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Collaborators

University Grenoble Alps
Act For Chronic Diseases
HP2 laboratory INSERM U1042

Investigators

  • Principal Investigator: Anne-Laure Borel, Pr MD PhD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 15, 2014

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 24, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1327
  • 2013-A01097-38 (Registry Identifier: n°ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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