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Testosterone in Bariatric Patients
Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Summary
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.
Official title: Muscle Strength and -Mass After Bariatric Surgery - a Possible Effect of Testosterone Replacement Therapy? Randomized, Placebo-controlled and Double-blinded Study
Key Details
Gender
MALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2020-12-17
Completion Date
2025-12
Last Updated
2025-03-06
Healthy Volunteers
No
Interventions
Testosterone Undecanoate
The patients will be randomly assigned to either testosterone or placebo.
Locations (1)
HospitalSWD
Esbjerg, Denmark