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)

Phase 3

Withdrawn

• Conditions: Obstructive Sleep Apnea; Respiratory - Sleep apnoea; overweight/obesity; Hypogonadism- low testosterone; Diet and Nutrition - Obesity; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12612000536864
• Lead Sponsor: Woolcock

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Male
• Target Recruitment: 20

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).

Exclusion Criteria

1.Females
2.Anemia
3.Patients currently receiving CPAP-therapy
4.Severe OSA requiring immediate treatment due to severity or increased associated risk (eg Transport worker)
5.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.
6.Doctor diagnosed diabetes.
7. 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).
8.Demonstrated allergic-type reactions to sulfonamides.
9.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.
10.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).
11.Active peptic ulceration or gastrointestinal (GI) bleeding.
12.Patients with estimated creatinine clearance <30 mL/min.
13.Severe hepatic impairment (Child-Pugh score 10- classifies the severity of liver disease)
14.Perioperative CABG surgery, unstable (thrombus aetiology), significant IHD, peripheral artery, cerebrovascular disease
15.Drug and alcohol abuse/dependence
16. Shift workers or patients with an irregular sleep / wake routine.
17. Current smokers
18. Current infection
19. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Baseline (10 minute sampling over 12 hours)<br>3 months (10 minute sampling over 24 hours)];MINMOD (Modified Minimal Model) and HOMA (homeostasis model of assessment) for the measurement of insulin sensitivity[Baseline and 3 months];24-hour blood pressure monitoring[baseline and 3 months]