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ACTIVE NOT RECRUITING
NCT03721497
PHASE4

Testosterone in Bariatric Patients

Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

View on ClinicalTrials.gov

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

DRUG

Testosterone Undecanoate

The patients will be randomly assigned to either testosterone or placebo.

Locations (1)

HospitalSWD

Esbjerg, Denmark