| Trial ID: | L6949 |
| Source ID: | NCT03281083
|
| Associated Drug: |
Levothyroxine Sodium
|
| Title: |
Levothyroxine for Non-Alcoholic Fatty Liver Disease (NAFLD)
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Non-Alcoholic Fatty Liver Disease|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Levothyroxine Sodium
|
| Outcome Measures: |
Primary: Liver fat content, To ascertain whether administration of LT4 for 16 weeks by titrating the serum TSH to 0.34 mIU/L - 1.7 mIU /L reduces liver fat content by at least 3% among patients with type II DM as measured by functional MRI., 16 weeks | Secondary: HbA1c, To ascertain whether administration of LT4 for 16 weeks by titrating the serum TSH to 0.34mIU/L - 1.7 mIU/L can improve glycemic control in Type II diabetic patients with NAFLD measured by reduction in HbA1c., 16 weeks|Lipid profile, To ascertain whether administration of LT4 for 16 weeks by titrating the serum TSH to 0.34mIU/L - 1.7 mIU/L can improve serum lipid profile in Type II diabetic patients with NAFLD as measured by total serum cholesterol, HDL, LDL and total triglycerides., 16 weeks|Abdominal fat, To ascertain whether administration of LT4 for 16 weeks by titrating the serum thyroid stimulating hormone (TSH) to 0.34 mIU/L - 1.7 mIU /L reduces the proportion of liver fat over body fat, which is reflected by fat in abdominal subcutaneous and visceral tissues, among patients with type II diabetes as measured by functional MRI on abdomen., 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Duke-NUS Graduate Medical School | Collaborators: Singapore Clinical Research Institute|Institute for Human Development and Potential (IHDP), Singapore|Institute of Bioengineering and Bioimaging (IBB)|Tan Tock Seng Hospital|Singapore General Hospital|Ng Teng Fong General Hospital|Changi General Hospital|Khoo Teck Puat Hospital|National University Health System, Singapore
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
29
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-03-28
|
| Completion Date: |
2016-07-28
|
| Results First Posted: |
|
| Last Update Posted: |
2017-09-14
|
| Locations: |
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| URL: |
https://clinicaltrials.gov/show/NCT03281083
|
