The effect of non-steroidal anti-inflammatory drugs on hormones and metabolism in overweight men with low testosterone and obstructive sleep apnea (optional partner participation)
Endocrine and metabolic effects of non steroidal anti-inflammatory therapy in overweight, hypogonadal men with obstructive sleep apnea: A pilot study
Woolcock
20 participants
Jul 1, 2012
Interventional
Conditions
Summary
This is a parrallel randomised controlled pilot study designed to investigate the effect of non-steroidal therapy on inflammation in obstructive sleep apnea (OSA) with regard to sleep apnea severity, reproductive function, androgen profile, cardio-metabolic health and quality of life. This study will use the drug celecoxib (Celebrex) which is a marketed drug in Australia that is commonly prescribed for arthritic conditions to relieve joint pain. Participants will be asked to attend the clinic for a 3 month period involving 5 short visits and 2 overnight stays with PSG and blood sampling.
Eligibility
Inclusion Criteria5
- Males aged 18-65 with obstructive sleep apnea with respiratory disturbance Index (RDI) greater than or equal to 5/hr
- Overweight or obese (BMI > 27 kg.m-2)
- Hypogonadism (T < 10 nmol/L) measured on two occasions
- Waitlisted for CPAP-therapy or treatment refusers
- Medical history, physical examination and laboratory screening indicating no clinical or laboratory evidence for significant and uncontrolled cardiovascular (ischemic, hypertension), renal, liver disease (serum electrolytes, urea and creatinine, liver function tests and full blood count).
Exclusion Criteria19
- Females
- Anemia
- Patients currently receiving CPAP-therapy
- Severe OSA requiring immediate treatment due to severity or increased associated risk (eg Transport worker)
- Significant and uncontrolled cardiovascular (ischemic heart disease, Congestive heart failure (NYHA II-IV), , hypertension, stroke), renal, liver disease as determined by medical history, physical examination and laboratory screening indicating clinical or laboratory evidence.
- Doctor diagnosed diabetes.
- Known hypersensitivity to celecoxib or any of the excipients contained in the celeboxib capsules (lactose, sodium lauryl sulfate, povidine, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, iron yellow oxide, indigo carmine).
- Demonstrated allergic-type reactions to sulfonamides.
- Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other non-steroidal anti-inflammatory drugs, including other COX-2 specific inhibitors.
- Patients using other non-steroidal anti-inflammatory drugs because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions (excluding low dose < 150 mg daily aspirin).
- Active peptic ulceration or gastrointestinal (GI) bleeding.
- Patients with estimated creatinine clearance <30 mL/min.
- Severe hepatic impairment (Child-Pugh score 10- classifies the severity of liver disease)
- Perioperative CABG surgery, unstable (thrombus aetiology), significant IHD, peripheral artery, cerebrovascular disease
- Drug and alcohol abuse/dependence
- Shift workers or patients with an irregular sleep / wake routine.
- Current smokers
- Current infection
- Any chronic medical conditions likely, in the judgment of the investigator, that makes the patient unable to complete the study safely, or otherwise unsuitable for the study or that may interfere with or influence study treatment.
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Interventions
200 mg Celecoxib (oral capsule) once daily for 3 months Partner: no intervention however completion of questionnaires to gather information related to sleep and breathing as well as general health, sexual health, quality of life, relationships, mood and energy at baseline and at 3 months. This will take 20-30 minutes to complete.
Locations(1)
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ACTRN12612000536864