Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group
- Conditions
- Non Alcoholic Fatty Liver Disease
- Interventions
- Registration Number
- NCT01754714
- Lead Sponsor
- Abbott
- Brief Summary
Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1500 mg SAMe SAMe 1500 mg - 2000 mg SAMe SAMe 2000 mg - 1000 mg SAMe (S-adenosyl-L-methionine) SAMe 1000 mg -
- Primary Outcome Measures
Name Time Method Methionine Elimination Half-life Measured in Blood. 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
- Secondary Outcome Measures
Name Time Method Metabolic Panel (Metabolic Laboratory Parameters) change from baseline at 6 weeks Adiponectin
The Metabolic Clearance Rate Measured in the Blood. 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* Time to peak
Methionine Volume of Distribution at Week 7 (L) 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7* After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve. 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
Hepatic Panel (Liver Laboratory Parameters) change from baseline at 6 weeks ALT/AST ratio
Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters) change from baseline at 6 weeks oxidative stress marker (isoprostane level)
Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers) change from baseline at 6 weeks Hyaluronic acid
Trial Locations
- Locations (32)
Site Reference ID 93954
🇩🇪Frankfurt, Germany
Site Reference ID 93916
🇫🇷Nice, France
Site Reference ID 93895
🇫🇷Angers, France
Site Reference ID 93893
🇫🇷Paris, France
Site Reference ID 93935
🇩🇪Freiburg, Germany
Site Reference ID 93894
🇫🇷Bobigny, France
Site Reference ID 93913
🇫🇷Montpellier, France
Site Reference ID 93915
🇫🇷Paris, France
Site Reference ID 93914
🇫🇷Amiens, France
Site Reference ID 94014
🇩🇪Ulm, Germany
Site Reference ID 93974
🇵🇱Warsaw, Poland
Site Reference ID 93953
🇩🇪Bonn, Germany
Site Reference ID 93896
🇫🇷Pessac, France
Site Reference ID 93955
🇩🇪Halle, Germany
Site Reference ID 94015
🇩🇪Leipzig, Germany
Site Reference ID 93918
🇩🇪Mainz, Germany
Site Reference ID 93917
🇩🇪Hannover, Germany
Site Reference ID 93933
🇩🇪Homburg, Germany
Site Reference ID 93973
🇵🇱Krakow, Poland
Site reference ID/Investigator # 109455
🇵🇱Bydgoszcz, Poland
Site Reference ID 93958
🇵🇱Chorzow, Poland
Site Reference ID 93957
🇵🇱Myslowice, Poland
Site reference ID ORG-000907
🇷🇺Novosibirsk, Russian Federation
Site reference ID ORG-000905
🇷🇺Krasnoyarsk, Russian Federation
Site reference ID ORG-000906
🇷🇺Moscow, Russian Federation
Site reference ID ORG-000900
🇷🇺Nizhniy Novgorod, Russian Federation
Site reference ID ORG-000903
🇷🇺Omsk, Russian Federation
Site reference ID ORG-000920
🇷🇺Rostov-on-Don, Russian Federation
Site reference ID ORG-000904
🇷🇺Samara, Russian Federation
Site reference ID ORG-000901
🇷🇺Stavropol, Russian Federation
Site Reference ID 93975
🇵🇱Wroclaw, Poland
Site Reference ID 93956
🇵🇱Lodz, Poland