Clinical trial NCT03281083 (phase 2, status: terminated)
Conditions: non-alcoholic fatty liver disease, diabetes mellitus, type 2
ICD codes: Z52.6, K71.8, K71.7, A06.4, C22.0, C22.3, K70.0, E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: levothyroxine sodium
SMILES: N[C@@H](CC1=CC(I)=C(OC2=CC(I)=C(O)C(I)=C2)C(I)=C1)C(O)=O
Reason stopped: 
    difficult recruitment and end of funding.
  
Eligibility criteria:

        Inclusion Criteria:

          1. Male between 21 to 60 years of age

          2. Diagnosed with stable Type II diabetes mellitus (DM) with no changes in oral
             hypoglycaemic medications or dose for the last 2 months from the time of start LT4,
             and if on insulin < 10 units change in insulin dosage, documented by patient's medical
             records. The most recent HbA1C for the last 6 months from the time of start LT4 should
             be no more than 10%.

          3. If the subject is on statin medication, there should be no change in the medication or
             dose of statin for the last 2 months from the time of start LT4

          4. Baseline ALT <3 times upper limit of normal as per the institution's specified
             reference range , with a liver ultrasound showing presence of fatty liver (liver
             ultrasound will not be requested if a prior scan has been done within the past 6
             months from the time of screening)

          5. The IHL content on the MRI/MRS should be more than 10% to allow enrollment in the
             trial.

          6. Baseline TSH levels between 1 - 10 mIU/L

          7. Baseline heart rate <90 beats/min

          8. Ability to provide informed consent

        Exclusion Criteria:

          1. Subject with history of viral hepatitis (except subject with history of viral A
             hepatitis or history of viral E hepatitis that was diagnosed at least 1 year before),
             hepatocellular carcinoma, liver cirrhosis, heart disease, osteoporosis,
             hyper/hypothyroidism, anxiety disorder, Graves' disease, thyroid/liver surgery,
             lactose intolerance, or malabsorption

          2. Baseline estimated glomerular filtration rate (eGFR) < 60 ml/min

          3. Currently on or within 6 months from the time of screening on either thyroxine,
             thiazolidinedione (TZD), oral T4/T3, anticoagulants (coumadin and warfarin),
             anti-viral drugs such as the protease inhibitors (ritonavir, indinavir, lopinavir),
             phenytoin, colestyramine, aluminium containing drugs (antacids, sucralfate),
             salicylates (> 100mg/day), dicumarol, furosemide, or sevelamer

          4. Consumption of ethanol greater than 30g/day (i.e. 3 drinks/day or 21 drinks/week, with
             about 10g of alcohol per drink)

          5. Has advanced liver disease with a baseline NAFLD fibrosis score of >0.675 (stage 3 or
             4 fibrosis)

          6. Has an implant or device in the body which is not safe for MRI scan

          7. Baseline ECG findings considered to be clinically significant (e.g., ischemic changes,
             arrhythmias) by the Investigator(s)

          8. Subject with history of claustrophobia

          9. Baseline free T4 of more than the institution's specified reference range If a sole
             blood test result is deemed borderline according to the laboratory reference interval
             and not clinically significant, the investigator is authorized to exercise discretion.