BridgeMD
Compares treatment options for Fatty Liver
Official title Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism
ClinicalTrials.gov ID: NCT03851627
What this study is testing
What is Testosterone Undecanoate?
Testosterone Undecanoate is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for fatty liver.
Also referred to as Nebido.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The epidemics of obesity, MeTSy, T2DM and CVD are increasing worldwide. Non-alcoholic fatty liver disease (NAFLD) is becoming recognized as a condition possibly involved in the pathogenesis of these diseases.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, men only
You may be able to join if
- prediabetes/T2DM
- male sex
- HbA1c \>=5.7% -9.0% or fasting glucose \>=100mg/dl or postprandial glucose\>= 140mg/dl
- Age \>=18 -75 years
- BMI\>=25kg/m²
You likely can't join if
- Current testosterone treatment or testosterone replacement within the last 12 month
- Serum creatinine\>1,5mg/dl
- Liver enzymes above 3 fold normal range
- PSA\>4.0μg/l
- Hematocrit\>50%
- Known intolerance to testosterone undecanoate or any of its ingredients
See the full eligibility criteria
- prediabetes/T2DM
- male sex
- HbA1c \>=5.7% -9.0% or fasting glucose \>=100mg/dl or postprandial glucose\>= 140mg/dl
- Age \>=18 -75 years
- BMI\>=25kg/m²
- Hypogonadism assessed by laboratory testing (testosterone \< 4,04ng/ml (=14nmol/l) Metformin 8 weeks stable dose, SGLT2 inhibitors 3 months stable dose, DPP4 inhibitors 3 months stable dose, GLP1 RA 3 months stable dose...
- able and willing to not change diet and physical activity during enrollment in study
- consent and able to give informed consent.
- Current testosterone treatment or testosterone replacement within the last 12 month
- Serum creatinine\>1,5mg/dl
- Liver enzymes above 3 fold normal range
- PSA\>4.0μg/l
- Hematocrit\>50%
- Known intolerance to testosterone undecanoate or any of its ingredients
- Myocardial infarction within the last 12month
- Stroke within the last 12 month
- Untreated congestive heart disease
- malignancy within the last 5 years before randomization
- Prostate cancer or any suspicion thereof
- Breast cancer
- Liver tumor/cancer
- Epilepsy
- Migraine
- Presence of any absolute or relative contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye...
- patients on antidiabetic medication like Sulfonylurea or Glitazones.
- Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
- Known autoimmune disease or chronic inflammatory condition
- Other liver disease including chronic viral hepatitis (B or C), alcohol abuse, hemochromatosis, alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease, primary sclerosing cholangitis or primary biliary...
- Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
- History of bariatric surgery
- Treatment with anti-obesity drugs (e.g. sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.) leading to unstable body...
- people receiving antihypertensive medication and/or thyroid hormones, the dose(s) of which have not been stable for at least 6 weeks prior to baseline
- Uncontrolled/ untreated hypertension
- Current treatment with systemic steroids at time of informed consent. (Treatment with local and inhaled steroids is allowed)
- Donation of blood (\> 400 mL) during the previous 3 months prior to the screening visit or during the duration of the study
- Participation in another trial with an investigational drug within 30 days prior to informed consent.
- Pharmacist, study coordinator, other staff thereof, directly involved in the conduct of the protocol.
- contraindication for intramuscular injection (e.g patient receiving anticoagulants on a regular basis such as NOAKs or VKAs, or DAPT).
- COPD Gold IV or recurrent acute or allergic asthma (for MPI)
- Contraindications for cardiac stress test as acute myocardial infarction, instable angina, severe hypertension, myocarditis, life threatening rhythmic disorders without physical activity.
The study team makes the final eligibility decision.
Where it's taking place
- Vienna, Austria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vienna, Austria. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.