ObesityNCT02419092
Obstructive Sleep Apnea-induced Changes in Adipose and Liver Tissue and Effects of Massive Weight Loss on Inflammation
An observational study of Obesity and Obstructive Sleep Apnea, run by University of Aarhus at 1 site in Denmark.
Trial summary
UPDATED May 2016: Originally the study design included investigation of the effects of the bioactive compound resveratrol compared to placebo tablets and to CPAP treatment. Due to fewer subjects having OSA than estimated by pre-study and, therefore, difficulties in the recruiting process the investigators have found… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obesity, Obstructive Sleep Apnea
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2015to 19 Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study groups will be selected from subjects referred to the outpatient clinics in Central Denmark Region and who meet the national guideline criteria for bariatric surgery.
Who may be able to join
- Female/Male
- Legally competent (habil)
- 25-65 years old
- BMI > 35 and fulfill criteria for bariatric surgery in Denmark
- Written informed consent
Who cannot join
- Current treatment with CPAP
- Permanent treatment with glucocorticoids, NSAID or sleeping pills (otherwise discontinued for 1 week prior to inclusion)
- Severe heart, liver, kidney or lung disease
- Type 1 diabetes
- Work in transportation-related industry
- Pregnancy
- Substance abuse problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Inflammation Induced by Obstructive Sleep Apnea: Effects of Continuous Positive Airway Pressure (CPAP), Massive Weight Loss and the Bioactive Compound Resveratrol
UPDATED May 2016:
Originally the study design included investigation of the effects of the bioactive compound resveratrol compared to placebo tablets and to CPAP treatment. Due to fewer subjects having OSA than estimated by pre-study and, therefore, difficulties in the recruiting process the investigators have found it necessary to descale the study design. Hence, we have discontinued the resveratrol and CPAP intervention and will focus on the cross-sectional investigation of metabolic changes in subjects with and without OSA and the effect of weight loss after bariatric surgery on inflammation, OSA severity, metabolism and arterial stiffness.
Read more
Obstructive sleep apnea (OSA) is a common disorder especially among obese individuals and patients with type 2 diabetes. OSA is associated with an increased morbidity and mortality.
Continuous positive airway pressure (CPAP) is the standard treatment. Also weight loss is known to reduce the severity of OSA, especially bariatric surgery has proven effective because of the massive weight loss.
The investigators hypothesize that OSA via pro-inflammatory responses in various tissues causes low-grade inflammation which ultimately induce the associated co-morbidities. The investigators hypothesize that massive weight loss after bariatric surgery have beneficial effects on severity of OSA, inflammatory status and improves insulin sensitivity.
Read the detailed description
UPDATED May 2016:
Originally the study design included investigation of the effects of the bioactive compound resveratrol compared to placebo tablets and to CPAP treatment. Due to fewer subjects having OSA than estimated by pre-study and, therefore, difficulties in the recruiting process the investigators have found it necessary to descale the study design. Hence, we have discontinued the resveratrol and CPAP intervention and will focus on the cross-sectional investigation of metabolic changes in subjects with and without OSA and the effect of weight loss after bariatric surgery on inflammation, OSA severity, metabolism and arterial stiffness.
OSA causes insulin resistance and seems to aggravate obesity related comorbidities such as hypertension, dyslipidemia and increase the risk of development of type 2 diabetes and non-alcoholic fatty liver disease.
More mechanisms may be involved in the pathogenesis of these negative effects from OSA but hypoxia-induced low-grade inflammation may play a central role since the levels of inflammatory markers generally are elevated in OSA. The tissues which are responsible for these systemic alterations are not known, however, adipose tissue might be a good candidate since it is known from studies that human adipose tissue can influence systemic inflammation.
Some studies even describe a small but significant anti-inflammatory effect and a beneficial effect on glucose metabolism following CPAP treatment. In addition, weight loss in patients with OSA is known to reduce the severity of or completely eliminate OSA.
The purpose of this study is primarily to investigate:
- the metabolic changes in adipose and liver tissue induced by OSA in order to better understand how OSA negatively affects whole-body metabolism
- the effect of weight loss after bariatric surgery on systemic inflammation, metabolism and the severity of OSA
24 subjects scheduled to undergo bariatric surgery will be recruited. They will all be screened for OSA. 12 subjects without OSA and 12 subjects with OSA will be included and examined before surgery and 6 months post-surgery.
The investigators will look at changes in:
- Inflammation-markers
- Biochemical markers of fat and sugar-metabolism
- Gene-expression in adipose and liver-tissue
- Severity of OSA
- Pulse-wave velocity
- Conditions
- Obesity, Obstructive Sleep Apnea
- Keywords
- Inflammation, Insulin resistance, Bariatric surgery
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnea | Subjects scheduled to undergo bariatric surgery and with Obstructive Sleep Apnea | |
| No Obstructive Sleep Apnea, controls | Subjects scheduled to undergo bariatric surgery and without Obstructive Sleep Apnea, control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic changes in adipose and liver tissue induced by OSA. Obese subjects with OSA will be compared to obese subjects without OSA.
Cross-sectional genetic and metabolic analysis of biopsies and blood samples obtained in relation to bariatric surgery on subjects with and without sleep apnea. In tissue samples gene-expression profile is measured using Affymetrix gene array and blood samples are used for metabolic profiling and inflammatory markers (hs-CRP, TNFalfa, IL-6, IL-8, adiponectin, leptin, MCP-1, FGF211, CD163)
Measured: Biopsies and blood samples obtained in relation to bariatric surgery
Secondary outcomes (3)
Effect of bariatric surgery on adipose tissue inflammation and systemic inflammation.
Changes in inflammation markers (hs-CRP, TNFalfa, IL-6, IL-8, adiponectin, leptin, MCP-1, FGF21, CD163) in blood and adipose tissue.
Changes in expression of mRNA of the relevant inflammatory pathways assessed by gene expression studies.
Measured: Evaluated at time of bariatric surgery and at follow-up 6 months after bariatric surgery.
Effect of bariatric surgery on insulin sensitivity.
Changes in insulin sensitivity assessed by HOMA-IR, fructosamine and correction in oral anti diabetic medication.
Measured: Evaluated at time of bariatric surgery and at follow-up 6 months after bariatric surgery
Effect of bariatric surgery on the severity of OSA.
Changes in AHI-score and Sleepiness Score (based on questionnaires).
Measured: Evaluated at baseline, 4 weeks post-bariatric surgery and 6 months post-bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2017
- Study completion19 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steen B Pedersen, MD,Professor, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419092
- Sponsor's protocol ID
- LIRMOI-5-OSA
- Status last verified
- Jan 2016
- First submitted
- 30 Mar 2015
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Inflammation Induced by Obstructive Sleep Apnea: Effects of Continuous Positive Airway Pressure (CPAP), Massive Weight Loss and the Bioactive Compound Resveratrol
- ClinicalTrials.gov ID
- NCT02419092
- Acronym / sponsor ID
- LIRMOI-5-OSA
- Conditions
- Obesity, Obstructive Sleep Apnea
- Keywords
- Inflammation, Insulin resistance, Bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- 19 Sep 2017 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
UPDATED May 2016:
Originally the study design included investigation of the effects of the bioactive compound resveratrol compared to placebo tablets and to CPAP treatment. Due to fewer subjects having OSA than estimated by pre-study and, therefore, difficulties in the recruiting process the investigators have found it necessary to descale the study design. Hence, we have discontinued the resveratrol and CPAP intervention and will focus on the cross-sectional investigation of metabolic changes in subjects with and without OSA and the effect of weight loss after bariatric surgery on inflammation, OSA severity, metabolism and arterial stiffness.
Obstructive sleep apnea (OSA) is a common disorder especially among obese individuals and patients with type 2 diabetes. OSA is associated with an increased morbidity and mortality.
Continuous positive airway pressure (CPAP) is the standard treatment. Also weight loss is known to reduce the severity of OSA, especially bariatric surgery has proven effective because of the massive weight loss.
The investigators hypothesize that OSA via pro-inflammatory responses in various tissues causes low-grade inflammation which ultimately induce the associated co-morbidities. The investigators hypothesize that massive weight loss after bariatric surgery have beneficial effects on severity of OSA, inflammatory status and improves insulin sensitivity.
Detailed description
UPDATED May 2016:
Originally the study design included investigation of the effects of the bioactive compound resveratrol compared to placebo tablets and to CPAP treatment. Due to fewer subjects having OSA than estimated by pre-study and, therefore, difficulties in the recruiting process the investigators have found it necessary to descale the study design. Hence, we have discontinued the resveratrol and CPAP intervention and will focus on the cross-sectional investigation of metabolic changes in subjects with and without OSA and the effect of weight loss after bariatric surgery on inflammation, OSA severity, metabolism and arterial stiffness.
OSA causes insulin resistance and seems to aggravate obesity related comorbidities such as hypertension, dyslipidemia and increase the risk of development of type 2 diabetes and non-alcoholic fatty liver disease.
More mechanisms may be involved in the pathogenesis of these negative effects from OSA but hypoxia-induced low-grade inflammation may play a central role since the levels of inflammatory markers generally are elevated in OSA. The tissues which are responsible for these systemic alterations are not known, however, adipose tissue might be a good candidate since it is known from studies that human adipose tissue can influence systemic inflammation.
Some studies even describe a small but significant anti-inflammatory effect and a beneficial effect on glucose metabolism following CPAP treatment. In addition, weight loss in patients with OSA is known to reduce the severity of or completely eliminate OSA.
The purpose of this study is primarily to investigate:
- the metabolic changes in adipose and liver tissue induced by OSA in order to better understand how OSA negatively affects whole-body metabolism
- the effect of weight loss after bariatric surgery on systemic inflammation, metabolism and the severity of OSA
24 subjects scheduled to undergo bariatric surgery will be recruited. They will all be screened for OSA. 12 subjects without OSA and 12 subjects with OSA will be included and examined before surgery and 6 months post-surgery.
The investigators will look at changes in:
- Inflammation-markers
- Biochemical markers of fat and sugar-metabolism
- Gene-expression in adipose and liver-tissue
- Severity of OSA
- Pulse-wave velocity
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea | – | –Subjects scheduled to undergo bariatric surgery and with Obstructive Sleep Apnea |
| No Obstructive Sleep Apnea, controls | – | –Subjects scheduled to undergo bariatric surgery and without Obstructive Sleep Apnea, control group |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study groups will be selected from subjects referred to the outpatient clinics in Central Denmark Region and who meet the national guideline criteria for bariatric surgery.
Key inclusion criteria (5 listed)
- Female/Male
- Legally competent (habil)
- 25-65 years old
- BMI > 35 and fulfill criteria for bariatric surgery in Denmark
- Written informed consent
Key exclusion criteria (7 listed)
- Current treatment with CPAP
- Permanent treatment with glucocorticoids, NSAID or sleeping pills (otherwise discontinued for 1 week prior to inclusion)
- Severe heart, liver, kidney or lung disease
- Type 1 diabetes
- Work in transportation-related industry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Metabolic changes in adipose and liver tissue induced by OSA. Obese subjects with OSA will be compared to obese subjects without OSA.
Time frame: Biopsies and blood samples obtained in relation to bariatric surgery
Cross-sectional genetic and metabolic analysis of biopsies and blood samples obtained in relation to bariatric surgery on subjects with and without sleep apnea. In tissue samples gene-expression profile is measured using Affymetrix gene array and blood samples are used for metabolic profiling and inflammatory markers (hs-CRP, TNFalfa, IL-6, IL-8, adiponectin, leptin, MCP-1, FGF211, CD163)
3 secondary outcomes
Effect of bariatric surgery on adipose tissue inflammation and systemic inflammation.
Time frame: Evaluated at time of bariatric surgery and at follow-up 6 months after bariatric surgery.
Effect of bariatric surgery on insulin sensitivity.
Time frame: Evaluated at time of bariatric surgery and at follow-up 6 months after bariatric surgery
Effect of bariatric surgery on the severity of OSA.
Time frame: Evaluated at baseline, 4 weeks post-bariatric surgery and 6 months post-bariatric surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steen B Pedersen, MD,Professor principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obstructive Sleep Apnea, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic changes in adipose and liver tissue induced by OSA. Obese subjects with OSA will be compared to obese subjects without OSA. (time frame: Biopsies and blood samples obtained in relation to bariatric surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.