Authors
»
Woolcock -More
Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2012
INTERVENTION: 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. CONDITION: Hypogonadism‐ low testosterone Obstructive Sleep Apnea overweight/obesity PRIMARY OUTCOME: 24‐hour blood pressure monitoring MINMOD (Modified Minimal Model) and HOMA (homeostasis model of assessment) for the measurement of insulin sensitivity Serial repetitive testosterone, estradiol, luteinizing and follicle stimulating hormone concentrations sampled over 12 and 24 hours. Free and total hormone concentrations will be calculated using mass equations and the outcome will be assessed using serum assays. SECONDARY OUTCOME: Cardiovascular health (lipid profiles, anthropometry, body composition (BIA scale), blood pressure, cardiovascular risk as assessed by diagnosis of Metabolic Syndrome and Framingham risk score). General quality of life (QOL) measurements (SF36, ESS, FOSQ, DASS, IWqOL) Inflammatory markers (micro‐CRP, ESR, WBC, IL‐1, IL‐6, IL‐8, IL‐10, IL‐1RA and TNF‐alpha) assessed through serum or plasma assays Metabolic markers (insulin, fasting blood glucose, adiponectin, leptin, ghrelin) assessed through serum or plasma assays Motivation (compliance, completion) through medication diaries (to ensure participants are taking their medication) and their completion of the trial (attrition rates) Other hormones and binding globulins (eg ACTH, cortisol, testosterone, estradiol, LH, FSH, SHBG) Partner: Quality of life measurements (SF36, ESS, FOSQ, DASS, MAPQ) Partner: Relationship quality measurements (SERS, Dyadic Adjustment Scale, Female Sexual Functioning Questionnaire) Physical Activity Questionnaire (IPAQ) Polysomnography (PSG) Sex specific quality of life [International Index of Erectile Function (IIEF), Brief Male Sexual Function Inventory (BMSFI)], European Male Ageing Study Sexual Function Questionnaire (EMAS) Sleep quality and activity counts via actigraphy INCLUSION CRITERIA: 1. Males aged 18‐65 with obstructive sleep apnea with respiratory disturbance Index (RDI) greater than or equal to 5/hr 2. Overweight or obese (BMI > 27 kg.m‐2) 3. Hypogonadism (T < 10 nmol/L) measured on two occasions 4. Waitlisted for CPAP‐therapy or treatment refusers 5. 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).
Epistemonikos ID: 35a95376716d4bb2cf5cb153049840d02847a75b
First added on: Aug 25, 2024