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Testosterone in Bariatric Patients

NCT03721497 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

  • Bariatric Surgery Candidate
  • Male Hypogonadism
  • Muscle Loss

Interventions

DRUG

Testosterone Undecanoate

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

Sponsors & Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Principal Investigators

  • Line V Magnussen, MD, PhD · Esbjerg Hospital - University Hospital of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03721497 on ClinicalTrials.gov