Obstructive Sleep Apnea-induced Changes in Adipose and Liver Tissue and Effects of Massive Weight Loss on Inflammation

NCT02419092 | Completed DMC

• 1 other identifier: LIRMOI-5-OSA
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obesity; Obstructive Sleep Apnea

Keywords

Inflammation; Insulin resistance; Bariatric surgery

Outcome Measures

Primary Outcomes (1)

• 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)

  Biopsies and blood samples obtained in relation to bariatric surgery

Secondary Outcomes (3)

• Effect of bariatric surgery on adipose tissue inflammation and systemic inflammation.

  Evaluated at time of bariatric surgery and at follow-up 6 months after bariatric surgery.

• Effect of bariatric surgery on insulin sensitivity.

  Evaluated at time of bariatric surgery and at follow-up 6 months after bariatric surgery

• Effect of bariatric surgery on the severity of OSA.

  Evaluated at baseline, 4 weeks post-bariatric surgery and 6 months post-bariatric surgery

Other Outcomes (1)

• Arterial stiffness assessed by office carotid-femoral pulse-wave

  Evaluated at baseline, end of intervention and 6 months post-bariatric surgery

Study Arms (2)

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

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Female/Male
• Legally competent (habil)
• years old
• BMI \> 35 and fulfill criteria for bariatric surgery in Denmark
• Written informed consent

You may not qualify if:

• Current treatment with CPAP
• Severe heart, liver, kidney or lung disease
• Type 1 diabetes
• Work in transportation-related industry
• Pregnancy
• Substance abuse problem

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, urine, subcutaneous adipose tissue, visceral adipose tissue and liver tissue.

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive; Inflammation; Insulin Resistance

Condition Hierarchy (Ancestors)

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

Study Officials

• Steen B Pedersen, MD,Professor

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 17, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 19, 2017
• Last Updated: October 17, 2017

Record last verified: 2016-01

Locations

DK (1)