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A Study of Surgical Weight Loss to Treat Obstructive Sleep Apnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Kuopio University Hospital
Sponsor:
Collaborators:
Helsinki University Central Hospital
Turku University Hospital
Oulu University Hospital
Vaasa Central Hospital, Vaasa, Finland
National Institute for Health and Welfare, Finland
Helsingin Uniklinikka
Central Hospital of Kanta-Hame
Information provided by (Responsible Party):
Juha Seppa, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT01080404
First received: March 3, 2010
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Obesity
Procedure: Bariatric surgery
Device: Continuous positive airway pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Obesity, Metabolism and Obstructive Sleep Apnea: Prevalence and the Effect of Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • The effect of bariatric surgery as a treatment of OSA [ Time Frame: 1- and 5-year follow-up ] [ Designated as safety issue: No ]
    To evaluate the effect of bariatric surgery as a treatment of OSA measured by objective (cardio-respiratory recording) and subjective parameters (questionnaires).


Secondary Outcome Measures:
  • The prevalence of OSA in morbidly obese patients undergoing bariatric surgery [ Time Frame: At the baseline ] [ Designated as safety issue: No ]
    To detect the prevalence of OSA in morbidly obese patients undergoing bariatric surgery in Finland.

  • The effect of bariatric surgery compared with CPAP treatment as a treatment of OSA [ Time Frame: 6-month follow-up ] [ Designated as safety issue: No ]
    To evaluate the effect of bariatric surgery compared with CPAP treatment as a treatment of OSA measured by objective (cardio-respiratory recording) and subjective (questionnaires) parameters.

  • The effect of surgically induced weight loss on metabolism. [ Time Frame: 3-, 6-, 12-, 60-month follow-up ] [ Designated as safety issue: No ]
    To study the effect of surgically induced weight loss on glucose tolerance, insulin resistance and lipid and energy metabolism.

  • The effect of weight loss on low-grade inflammation and peripheral blood mononuclear cells (PBMCs) gene expression [ Time Frame: 3-, 6-, 12-, 60-month follow-up ] [ Designated as safety issue: No ]
    To study the effect of weight loss on OSA, low-grade inflammation and peripheral blood mononuclear cells (PBMCs) gene expression

  • The postoperative recovery after bariatric surgery [ Time Frame: 3-, 6-, 12-, 60-month follow-up ] [ Designated as safety issue: Yes ]
    To evaluate the postoperative recovery after bariatric surgery

  • The effect of CPAP treatment on metabolism in morbidly obese patients with OSA [ Time Frame: 3-, 6-month follow-up ] [ Designated as safety issue: No ]
    To evaluate the effect of CPAP treatment on metabolism in obese patients with OSA

  • The effect of CPAP treatment combined with bariatric surgery in obese patients with OSA. [ Time Frame: 1- and 5-year follow-up ] [ Designated as safety issue: No ]
    To evaluate the effect of CPAP treatment combined with bariatric surgery in obese patients with OSA.


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bariatric surgery (overall study)
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
A standardized laparoscopic gastric bypass using Roux-en-Y technique
Experimental: Bariatric surgery (randomised substudy)
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
A standardized laparoscopic gastric bypass using Roux-en-Y technique
Active Comparator: CPAP (randomised substudy)
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
The patients are given standardized CPAP treatment according to current clinical guidelines.

Detailed Description:

Sleep disturbances have become a public health concern in the modern society, affecting millions of people. Obstructive sleep apnea (OSA) is one of the commonest sleep disturbances. Obstructive sleep apnea affects mostly middle-aged work force, causing a negative impact on public health since it increases both mortality and morbidity. In Finland, there are approximately 150,000 OSA patients, of whom 15,000 patients have a severe, 50,000 a moderate and 85,000 a mild form of the disease. The number of the patients is assumed to be strongly underestimated and it has been estimated that one out of five adults has at least mild OSA. OSA is tightly linked with metabolic abnormalities that contribute to an increased morbidity and mortality through cardiovascular disease. In addition, accidents by daytime sleepiness deteriorate person's quality of life and working capacity.

The most important risk factor for OSA is obesity, and thus effective treatment of obesity is first-line treatment of OSA. In a recent study it was observed that lifestyle intervention with an early weight reduction can be a curative treatment is mild OSA. However, regardless of these promising results weight reduction as a treatment of OSA is still underestimated. Particularly alarming is the exploding prevalence of morbid obesity, and that estimations have predicted this group of patients to increase most rapidly. Unfortunately, conventional lifestyle and weight reduction interventions have proven to be ineffective in long-term follow-up in these patients. In contrast, the permanent weight reduction achieved by bariatric surgery has been found to have favourable effects on diabetes, hyperlipidemia, hypertension, and also on OSA.

The treatment of OSA is demanding for both patients and physicians. There are no simple treatment modalities. Thus, there exists a definite need to improve the existing treatment modalities and to search new ones. The golden standard for treating patients with OSA is nasal continuous airway pressure (CPAP). It has been found to effective, but somewhat poor adherence (40-50%) to the treatment is certainly a major limitation. Moreover, there is little evidence about the possible beneficial metabolic effects of CPAP. Considering the rapid increase of obesity and the unsatisfactory adherence to CPAP treatment, bariatric surgery offers an interesting and viable option alongside with the conventional treatment modalities of OSA. 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 could be higher than believed, even 70-80% in morbidly obese patients. There is a definite need for large, well-designed, prospective clinical studies on 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 OSA as a major risk factor in the development of cardiovascular diseases should provoke concepts to improve better clinical guidelines of diagnostics and treatments in a risk group, such as obese patients.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For the overall study:

  1. Age 18-65 years
  2. BMI 35 and over with comorbidity (such as sleep apnea)
  3. BMI 40 and over without any comorbidities
  4. Obtained written consent

Additionally for the randomised substudy:

  1. BMI 35-45
  2. AHI 5-30

Exclusion Criteria:

  1. On-going active treatment of OSA of any kind (during the last 1 month)
  2. Pregnancy
  3. Alcoholism
  4. Eating disorders or severe depression
  5. Other severe diseases contra-indicating bariatric surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080404

Contacts
Contact: Henri Tuomilehto, MD, PhD +35817173311 henri.tuomilehto@oivauni.fi
Contact: Mikael Victorzon, MD, PhD +35863231111 mikael.victorzon@vshp.fi

Locations
Finland
Helsinki Sleep Center Not yet recruiting
Helsinki, Finland, 00420
Contact: Markku Partinen, MD, PhD       markku.partinen@helsinki.fi   
Principal Investigator: Markku Partinen, MD, PhD         
Helsinki University hospital Not yet recruiting
Helsinki, Finland, 00029
Contact: Marja Leivonen, MD, PhD       marja.leivonen@hus.fi   
Principal Investigator: Marja Leivonen, MD, PhD         
Sub-Investigator: Anne Juuti, MD, PhD         
National Institute for Health and Welfare Not yet recruiting
Helsinki, Finland, 00271
Contact: Markku Peltonen, PhD       markku.peltonen@thl.fi   
Principal Investigator: Markku Peltonen, PhD         
Kuopio University hospital Recruiting
Kuopio, Finland, 70211
Contact: Juha Seppä, MD, PhD       juha.seppä@kuh.fi   
Sub-Investigator: Matti Pääkkönen, MD, PhD         
Sub-Investigator: Sari Grönlund, MD, PhD         
Principal Investigator: Henri Tuomilehto, MD, PhD         
Principal Investigator: Jussi Pihlajamäki, MD, PhD         
Sub-Investigator: Juha Seppä, MD, PhD         
Sub-Investigator: Helena Gylling, MD, PhD         
Sub-Investigator: Matti Uusitupa, MD, PhD         
Sub-Investigator: Esa Mervaala, MD, PhD         
Eastern Finland Laboratory Centre Recruiting
Kuopio, Finland, 70211
Contact: Kari Punnonen, MD, PhD       kari.punnonen@islab.fi   
Principal Investigator: Kari Punnonen, MD, PhD         
Päijät-Häme Central hospital Not yet recruiting
Lahti, Finland, 15850
Contact: Jyrki Kössi, MD, PhD       jyrki.kossi@phks.fi   
Principal Investigator: Jyrki Kössi, MD, PhD         
Oulu University hospital Not yet recruiting
Oulu, Finland, 90029
Contact: Vesa Koivukangas, MD, PhD       vesa.koivukangas@ppshp.fi   
Principal Investigator: Vesa Koivukangas, MD, PhD         
Sub-Investigator: Timo Heikkinen, MD, PhD         
Turku University hospital Not yet recruiting
Turku, Finland, 20521
Contact: Paulina Salminen, MD, PhD       paulina.salminen@tyks.fi   
Principal Investigator: Paulina Salminen, MD, PhD         
Sub-Investigator: Jari Ovaska, MD, PhD         
Vaasa Central hospital Recruiting
Vaasa, Finland, 65100
Contact: Mikael Victorzon, MD, PhD       mikael.victorzon@vshp.fi   
Principal Investigator: Mikael Victorzon, MD, PhD         
Sub-Investigator: Pipsa Peromaa, MD         
Sponsors and Collaborators
Kuopio University Hospital
Helsinki University Central Hospital
Turku University Hospital
Oulu University Hospital
Vaasa Central Hospital, Vaasa, Finland
National Institute for Health and Welfare, Finland
Helsingin Uniklinikka
Central Hospital of Kanta-Hame
Investigators
Study Director: Henri Tuomilehto, MD, PhD Kuopio University Hospital
Principal Investigator: Mikael Victorzon, MD, PhD Vaasa Central Hospital, Vaasa, Finland
Principal Investigator: Jussi Pihlajamäki, MD, PhD Kuopio University Hospital
  More Information

No publications provided

Responsible Party: Juha Seppa, PhD, MD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT01080404     History of Changes
Other Study ID Numbers: KUH5551821
Study First Received: March 3, 2010
Last Updated: August 13, 2013
Health Authority: Finland: Research Ethics Committee

Keywords provided by Kuopio University Hospital:
Obstructive sleep apnea
Obesity
Metabolism
Bariatric surgery
CPAP

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Body Weight
Dyssomnias
Nervous System Diseases
Nutrition Disorders
Overnutrition
Overweight
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 27, 2014