| Trial ID: | L0811 |
| Source ID: | SLCTR/2017/033
|
| Associated Drug: |
Omega-3 Fatty Acids
|
| Title: |
Effect of Omega 3 Fatty Acid supplementation on hepatic steatosis and liver stiffness in patients with nonalcoholic fatty liver disease: a Randomized Controlled Trial
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic fatty liver disease (NAFLD)
|
| Interventions: |
Patients attending outpatient department of Hepatology, Bangabandhu Sheikh Mujib Medical University (BSMMU) with sonological evidence of fatty liver will be recruited. Participants meeting inclusion and exclusion criteria will be allocated to the study a
|
| Outcome Measures: |
Liver stiffness measurement (LSM) as determined by fibroscan of liver [At baseline and 6 months after the commencement of the intervention (end of treatment)]<br>Hepatic steatosis with controlled attenuation parameter (CAP) [At baseline and 6 months after the commencement of the intervention (end of treatment)]<br>Blood pressure (using standardized mercury sphygmomanometer and measurement techniques) [At baseline and 6 months after the commencement of the intervention (end of treatment)
<br>
<br>Note: FBS, 2HABF & HbA1c and Lipid profile will be done at baseline, then monthly for 3 months and at the end of 6 months for patients with diabetes and dyslipiaemia]<br>Anthropometric parameters: waist circumference and body mass index (BMI) [At baseline and 6 months after the commencement of the intervention (end of treatment)]<br>Liver functions tests as determined by serum alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamyl transpeptidase (GGT) [At baseline and 6 months after the commencement of the intervention (end of treatment)]<br>Lipid profile as determined by total cholesterol (TC), triglycerides (TG), high density lipoproteins (HDL) and low density lipoproteins (LDL) [At baseline and 6 months after the commencement of the intervention (end of treatment)
<br>
<br>Lipid profile will be done at baseline, then monthly for 3 months and at the end of 6 months for patients with diabetes and dyslipiaemia]<br>Metabolic parameters: fasting blood sugar (FBS), blood sugar 2 hours after breakfast (2HABF), glycosylated haemoglobin (HbA1c), beta cell function using HOMA-IR (homeostasis model assessment ?€? insulin resistance) [At baseline and 6 months after the commencement of the intervention (end of treatment)
<br>
<br>FBS, 2HABF & HbA1c will be done at baseline, then monthly for 3 months and at the end of 6 months for patients with diabetes and dyslipiaemia]<br>
|
| Sponsor/Collaborators: |
Department of Hepatology,Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
|
| Gender: |
--
|
| Age: |
nannan
|
| Phases: |
Not applicable
|
| Enrollment: |
100 (50 in each arm)
|
| Study Type: |
Interventional
|
| Study Designs: |
Randomized controlled trial
|
| Start Date: |
28/09/2017
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
7 February 2022
|
| Locations: |
Bangladesh
|
| URL: |
https://slctr.lk/trials/slctr-2017-033
|
