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Effect of testosterone replacement associated with bariatric surgery in men with obesity

Effect of testosterone replacement associated with bariatric surgery in men with obesity: a randomized trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9qks3pc
Enrollment
Unknown
Registered
2023-07-13
Start date
2023-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

This is a parallel study, with two arms, double-blind, randomized, controlled, carried out with patients undergoing bariatric surgery. A group of 25 patients will receive three doses of testosterone u
E02.65

Sponsors

Hospital e Maternidade São Domingos
Lead Sponsor
Universidade Federal do Maranhão
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Patients with Body Mass Index - BMI > 35; weighing up to 180 kg; with low testosterone levels (<350 ng/dl); classified as hypogonadal; who voluntarily agreed to participate in the research, in addition to understanding and consenting to participation through the TCLE (Free and Informed Consent Form)

Exclusion criteria

Exclusion criteria: Interest in fertility in the 6 months following therapy; diagnosis of active prostate or breast cancer; previous diagnosis of prostate cancer, with less than two years of curative treatment; previous diagnosis of breast cancer; severe voiding symptoms, translated through the IPSS score (International Prostatic Symptom Score) > 19; severe cardiopulmonary disease (eg unstable angina, recent myocardial infarction); personal or family history of thromboembolism; hematocrit above 48%; patients with implanted medical devices such as pacemakers or essential support devices such as monitors

Design outcomes

Primary

MeasureTime frame
Evaluate testosterone replacement in quality of life and sex in the weight loss process; It is expected a better quality of life and sexual score in the weight loss process after bariatric surgery with testosterone replacement

Secondary

MeasureTime frame
Evaluate the impact of testosterone replacement on metabolic and inflammatory parameters; Testosterone replacement is expected to optimize the improvement of metabolic and inflammatory parameters;Evaluate the impact of testosterone replacement on the maintenance of muscle mass in the weight loss process; Testosterone replacement is expected to conserve muscle mass in the weight loss process

Countries

Brazil

Contacts

Public ContactRodrigo Diniz

Universidade Federal do Maranhão

rodrigo.urologia@hotmail.com+55 98 98113-2969

Outcome results

None listed

Source: REBEC (via WHO ICTRP)