Status:
TERMINATED
Levothyroxine for Non-Alcoholic Fatty Liver Disease (NAFLD)
Lead Sponsor:
Duke-NUS Graduate Medical School
Collaborating Sponsors:
Singapore Clinical Research Institute
Institute for Human Development and Potential (IHDP), Singapore
Conditions:
Non-Alcoholic Fatty Liver Disease
Diabetes Mellitus, Type 2
Eligibility:
MALE
21-60 years
Phase:
PHASE2
Brief Summary
Background: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of disorders characterized by lipid accumulation in hepatocytes. Evidence shows that thyroid hormone might be beneficial for this co...
Detailed Description
Background: Non-alcoholic fatty liver disease (NAFLD) is a spectrum of disorders characterized by lipid accumulation in hepatocytes. These conditions range from fat accumulation in the liver (hepatost...
Eligibility Criteria
Inclusion
- Male between 21 to 60 years of age
- 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%.
- 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
- 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)
- The IHL content on the MRI/MRS should be more than 10% to allow enrollment in the trial.
- Baseline TSH levels between 1 - 10 mIU/L
- Baseline heart rate \<90 beats/min
- Ability to provide informed consent
Exclusion
- 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
- Baseline estimated glomerular filtration rate (eGFR) \< 60 ml/min
- 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
- Consumption of ethanol greater than 30g/day (i.e. 3 drinks/day or 21 drinks/week, with about 10g of alcohol per drink)
- Has advanced liver disease with a baseline NAFLD fibrosis score of \>0.675 (stage 3 or 4 fibrosis)
- Has an implant or device in the body which is not safe for MRI scan
- Baseline ECG findings considered to be clinically significant (e.g., ischemic changes, arrhythmias) by the Investigator(s)
- Subject with history of claustrophobia
- 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.
Key Trial Info
Start Date :
March 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03281083
Start Date
March 28 2014
End Date
July 28 2016
Last Update
September 14 2017
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