Testosterone in Bariatric Patients

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital of South West Denmark
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

Inclusion Criteria:

• Eligible for bariatric surgery according to the Danish national criteria (i.e. aged 18-60 years, BMI >35 kg/m2 with specific secondary disease or BMI >40 kg/m2 with significant health issues assessed by the multidisciplinary bariatric team) [42]

• Caucasian men

• Total testosterone < 12.0 nmol/l

• No contraindications for testosterone treatment

Exclusion Criteria:

• Previously diagnosed with prostate, mammae or liver cancer. Any other cancer within the last 5 years.

• Hypersensitivity to the active substance or to any of the excipients in Nebido®

• Symptomatic heart disease NYHA >2

• Recently thromboembolic disease <3 months

• PSA >4.0 ug/l or PSA>3.0 ug/l and lower urinary tract symptoms

• Disability that severely affect the ability to perform exercise training

• EVF > 52%