A Study of Surgical Weight Loss to Treat Obstructive Sleep Apnea

NCT01080404 | Unknown

• 1 other identifier: KUH5551821
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 9

Brief Summary

Obesity is an increasing problem worldwide. Over 20% of people in western societies are obese (BMI \>30kg/m2) and 1-2 % are morbidly obese (BMI \>40 kg/m2). According to the recent study 6.6% of Finns are severely obese (BMI \> 35kg/m2) and 2.0% are morbidly obese (BMI\>40kg/m2). Because conventional treatments often fail to induce sustained weight loss obesity surgery has increased rapidly in many countries. Currently, \> 300000 procedures are performed in the US each year. Thus in many European countries, including Finland, the need for obesity surgery is rapidly increasing. The most important risk factor also for obstructive sleep apnea (OSA) is obesity, and thus effective treatment of obesity is the first-line treatment of OSA. However, Reliable information of the prevalence of OSA in morbidly obese patients is still lacking. The current knowledge is based on small studies, which have demonstrated that the prevalence of OSA may be higher than believed, even 70-80% in morbidly obese patients. There is a definite need for large, well-designed, prospective clinical studies to evaluate the effects of weight reduction in OSA and other co-morbidities related to obesity. Ever increasing research data showing a strong link between obesity and OSA and their co-existence as a major risk factor in the development of cardiovascular diseases should provoke concepts to search better clinical guidelines of diagnostics and treatments in a risk group, such as morbidly obese patients.

Conditions

Obstructive Sleep Apnea; Obesity

Keywords

Obstructive sleep apnea; Obesity; Metabolism; Bariatric surgery; CPAP

Outcome Measures

Primary Outcomes (1)

• The effect of bariatric surgery as a treatment of OSA

  To evaluate the effect of bariatric surgery as a treatment of OSA measured by objective (cardio-respiratory recording) and subjective parameters (questionnaires).

  1- and 5-year follow-up

Secondary Outcomes (7)

• The prevalence of OSA in morbidly obese patients undergoing bariatric surgery

  At the baseline

• The effect of bariatric surgery compared with CPAP treatment as a treatment of OSA

  6-month follow-up

• The effect of surgically induced weight loss on metabolism.

  3-, 6-, 12-, 60-month follow-up

• The effect of weight loss on low-grade inflammation and peripheral blood mononuclear cells (PBMCs) gene expression

  3-, 6-, 12-, 60-month follow-up

• The postoperative recovery after bariatric surgery

  3-, 6-, 12-, 60-month follow-up

Study Arms (3)

Bariatric surgery (overall study)

EXPERIMENTAL

A prospective follow-up study is to estimate the prevalence of OSA and associated metabolic abnormalities in Finnish morbidly obese subjects and to evaluate the effects of bariatric surgery on OSA and associated metabolic abnormalities. The study is conducted in seven hospitals in Finland and 300 patients are planned to be recruited in the study.

Procedure: Bariatric surgery

Bariatric surgery (randomised substudy)

EXPERIMENTAL

As a substudy of a larger trial, a randomized study on the effects of bariatric surgery compared to CPAP treatment will be performed in obese (BMI 35-45) patients with OSA. The included 100 (15/center) patients are randomised to two groups: surgical intervention group (50) and CPAP group (50). Patients in the surgical intervention group undergo standardised surgical treatment (laparoscopic gastric bypass), including general health information, such as avoidance of smoking, alcohol drinking, and importance of healthy nutrition and regular exercise. The CPAP group will be assigned to CPAP treatment and they also receive the general health information.

Procedure: Bariatric surgery

CPAP (randomised substudy)

ACTIVE COMPARATOR

As a substudy of a larger trial, a randomized study on the effects of bariatric surgery compared to CPAP treatment will be performed in obese (BMI 35-45) patients with OSA. The included 100 patients are randomised to two groups: surgical intervention group (50) and CPAP group (50). Patients in the surgical intervention group undergo standardised surgical treatment (laparoscopic gastric bypass), including general health information, such as avoidance of smoking, alcohol drinking, and importance of healthy nutrition and regular exercise. The CPAP group will be assigned to CPAP treatment and they also receive the general health information.

Device: Continuous positive airway pressure

Interventions

Bariatric surgery PROCEDURE

A standardized laparoscopic gastric bypass using Roux-en-Y technique

Bariatric surgery (overall study); Bariatric surgery (randomised substudy)

Continuous positive airway pressure DEVICE

The patients are given standardized CPAP treatment according to current clinical guidelines.

CPAP (randomised substudy)

Eligibility Criteria

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

You may qualify if:

• For the overall study:
• Age 18-65 years
• BMI 35 and over with comorbidity (such as sleep apnea)
• BMI 40 and over without any comorbidities
• Obtained written consent
• Additionally for the randomised substudy:
• BMI 35-45
• AHI 5-30

You may not qualify if:

• On-going active treatment of OSA of any kind (during the last 1 month)
• Pregnancy
• Alcoholism
• Eating disorders or severe depression
• Other severe diseases contra-indicating bariatric surgery

Sponsors & Collaborators

• Kuopio University Hospital: lead
• Helsinki University Central Hospital: collaborator
• Turku University Hospital: collaborator
• Oulu University Hospital: collaborator
• Vaasa Central Hospital, Vaasa, Finland: collaborator
• Finnish Institute for Health and Welfare: collaborator
• Helsingin Uniklinikka: collaborator
• Kanta-Häme Central Hospital: collaborator

Study Sites (9)

Helsinki University hospital

Helsinki, 00029, Finland

Location

National Institute for Health and Welfare

Helsinki, 00271, Finland

Location

Helsinki Sleep Center

Helsinki, 00420, Finland

Location

Eastern Finland Laboratory Centre

Kuopio, 70211, Finland

Location

Kuopio University hospital

Kuopio, 70211, Finland

Location

Päijät-Häme Central hospital

Lahti, 15850, Finland

Location

Oulu University hospital

Oulu, 90029, Finland

Location

Turku University hospital

Turku, 20521, Finland

Location

Vaasa Central hospital

Vaasa, 65100, Finland

Location

Related Publications (1)

• Peromaa-Haavisto P, Tuomilehto H, Kossi J, Virtanen J, Luostarinen M, Pihlajamaki J, Kakela P, Victorzon M. Obstructive sleep apnea: the effect of bariatric surgery after 12 months. A prospective multicenter trial. Sleep Med. 2017 Jul;35:85-90. doi: 10.1016/j.sleep.2016.12.017. Epub 2017 Jan 12.

  PMID: 28549834 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Interventions

Bariatric Surgery; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Respiratory Therapy

Study Officials

• Henri Tuomilehto, MD, PhD

  Kuopio University Hospital

  STUDY DIRECTOR

• Mikael Victorzon, MD, PhD

  Vaasa Central Hospital, Vaasa, Finland

  PRINCIPAL INVESTIGATOR

• Jussi Pihlajamäki, MD, PhD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: March 3, 2010
• First Posted: March 4, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 20, 2020

Record last verified: 2020-02

Locations

FI (9)