Testosterone in Bariatric Patients

Bariatric surgery is an effective method in the treatment of severe obesity and type 2 diabetes mellitus achieving high remission rates. However, weight loss also causes loss of skeletal muscle and bone mass which at least partly could be prevented by exercise and dietary intervention although the counselling of obese and sedentary individuals in order to increase their physical activity presents a challenge. As up to 78.8% of men undergoing bariatric surgery have low levels of testosterone, testosterone therapy could be considered an attractive alternative or supplement to prevent the immense loss of muscle mass during weight loss. Furthermore, low testosterone levels are associated with sarcopenia, insulin resistance, increased body fat, reduced quality of life, loss of libido and reduced sexual function. The study is a long-term randomized, placebo-controlled trial investigating the effects of testosterone therapy combined with exercise and diet counselling on body composition, components of the metabolic syndrome, hormones, inflammation, sexual function and quality of life before and after weight loss in obese, hypogonadal men undergoing bariatric surgery.

NCT Number	NCT03721497
Lead Sponsor	Esbjerg Hospital - University Hospital of Southern Denmark
Conditions	Bariatric Surgery Candidate, Male Hypogonadism, Muscle Loss
Enrollment	64 participants
Start Date	2020-12-17
Primary Completion	2025-12 (estimated)
Study Completion	2025-12 (estimated)
Updated on ClinicalTrials.gov	2025-03-06