Clinical trial: Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Obese Men With T2DM and Hypogonadism (NCT03851627)

Eligibility criteria:
Inclusion Criteria:

          -  T2DM

          -  male sex

          -  HbA1c >=7,5% -11%

          -  Age >=18 -75 years

          -  BMI>=30kg/m²

          -  Hypogonadism assessed by laboratory testing (testosterone < 3,5ng/ml (=12nmol/l)

          -  Metformin, SGLT2 inhibitors, DPP4 inhibitors and long acting insulin (basal insulin) 8
             weeks stable dose

          -  able and willing to not change diet and physical activity during enrollment in study

          -  consent and able to give informed consent.

        Exclusion Criteria:

          -  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, ferromagnetic or electronically
             operated active devices like automatic cardioverter defibrillators, cochlear implants,
             insulin pumps and nerve stimulators, prosthetic heart valves etc.

          -  patients on antidiabetic medication like Sulfonylurea or Glitazones, GLP1A.

          -  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 cirrhosis, or liver
             cirrhosis of any etiology

          -  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 weight

          -  Subjects 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.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 19-year-old male came to clinic with some sexual concern.  He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates.  On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH.

Patient description (patient's own words): I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels.

Does the patient match the trial criteria? Contradiction