Testosterone in Bariatric Patients

NCT03721497 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2018-002365-19
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Maximal isometric muscle strength (N) in shoulder muscles

  shoulder elevation

  At baseline preoperatively and at weeks 0, 28 and 52 per/postoperatively

Secondary Outcomes (35)

• Change in Lean body mass (kg)

  At baseline preoperatively and at weeks 0, 28 and 52 per/postoperatively

• Change in Total bone mass and density (BMC and BMD)

  At baseline preoperatively and at weeks 0, 28 and 52 per/postoperatively

• Change in Total fat mass (kg)

  At baseline preoperatively and at weeks 0, 28 and 52 per/postoperatively

• Change in BMI (regional body composition)

  At baseline preoperatively and at weeks 0, 28 and 52 per/postoperatively

• Change in Waist/hip-ratio (regional body composition)

  At baseline preoperatively and at weeks 0, 28 and 52 per/postoperatively

Study Arms (2)

Testosterone Undecanoate

ACTIVE COMPARATOR

Inj. Testosterone undecanoat (Nebido®), 1000 mg im preoperative (baseline, weeks 6, 18 and 30 depending on time to surgery) and postoperative (weeks 4, 16, 28, 40)

Drug: Testosterone Undecanoate

Placebo

PLACEBO COMPARATOR

Inj. placebo preoperative (baseline, weeks 6, 18 and 30 depending on time to surgery) and postoperative (weeks 4, 16, 28, 40)

Drug: Testosterone Undecanoate

Interventions

Testosterone Undecanoate DRUG

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

Also known as: Placebo

Placebo; Testosterone Undecanoate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

HospitalSWD

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Eunuchism; Muscular Atrophy

Interventions

testosterone undecanoate

Condition Hierarchy (Ancestors)

Hypogonadism; Gonadal Disorders; Endocrine System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Line V Magnussen, MD, PhD

  Esbjerg Hospital - University Hospital of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD

Model Details: Randomized, placebo-controlled and double-blinded study

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 26, 2018
• Study Start: December 17, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

DK (1)