Metabolic Syndrome Clinical Trial
Official title:
A Randomized Double-blind Study of Testosterone Replacement Therapy or Placebo in Testicular Cancer Survivors With Mild Leydig Cell Insufficiency (Einstein-intervention)
The overall purpose of the study is to evaluate the effect of 12 months testosterone
replacement therapy in testicular cancer survivors with mild Leydig Cell Insufficiency in
order to reduce the risk of cardiovascular disease.
The primary study objective is to evaluate changes in insulin sensitivity. The secondary
study objective is to evaluate changes in the prevalence of metabolic syndrome, body
composition, systemic inflammation and symptoms of testosterone deficiency.
This is a single-center, randomized, double-blind, placebo-controlled intervention study,
designed to evaluate the effect of testosterone replacement therapy in testicular cancer
survivors with mild Leydig Cell Insufficiency.
70 subjects will be randomized to receive either testosterone replacement therapy or placebo.
The subjects will be invited for an information meeting where informed consent is signed. If
a subject is suitable for participation in the trial, subject will be randomized to
testosterone replacement therapy or placebo and baseline investigations will be performed.
Afterwards, a 52-weeks treatment period begins in which subjects receive a daily dose of
testosterone or placebo. Dose adjustment will be made three times during the first 8 weeks of
the study. Evaluation of primary and secondary endpoints will be performed after 26 weeks, at
the end of treatment (52 weeks) and three months after completion of treatment (week 64).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04635202 -
Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome
|
N/A | |
| Completed |
NCT04053686 -
An Intervention to Reduce Prolonged Sitting in Police Staff
|
N/A | |
| Completed |
NCT05343858 -
Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome
|
N/A | |
| Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
| Recruiting |
NCT05040958 -
Carotid Atherosclerotic Plaque Load and Neck Circumference
|
||
| Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
| Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
| Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
| Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
| Completed |
NCT03289897 -
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
|
N/A | |
| Recruiting |
NCT05956886 -
Sleep Chatbot Intervention for Emerging Black/African American Adults
|
N/A | |
| Completed |
NCT06057896 -
Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
|
||
| Active, not recruiting |
NCT03613740 -
Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
|
Phase 2 | |
| Completed |
NCT04498455 -
Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency
|
Phase 4 | |
| Completed |
NCT05688917 -
Green Coffee Effect on Metabolic Syndrome
|
N/A | |
| Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
| Completed |
NCT03697382 -
Effect of Daily Steps on Fat Metabolism
|
N/A | |
| Completed |
NCT03241121 -
Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
|
N/A | |
| Completed |
NCT04509206 -
Virtual Teaching Kitchen
|
N/A | |
| Completed |
NCT05124847 -
TREating Pediatric Obesity
|
N/A |