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

Phase 3

Completed

• Conditions: Non Alcoholic Fatty Liver Disease
• Interventions: Drug: SAMe 1500 mg; Drug: SAMe 2000 mg; Drug: SAMe 1000 mg

• 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

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-19
• Study First Submitted QC: 2012-12-19
• Study First Posted: 2012-12-21
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Results First Submitted: 2015-10-02
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-22
• Last Update Submitted: 2016-01-22
• Results First Posted: 2016-02-19
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

Not provided

Exclusion Criteria

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 93914; 🇫🇷 Amiens, France

Site Reference ID 93895; 🇫🇷 Angers, France

Site Reference ID 93894; 🇫🇷 Bobigny, France

Site Reference ID 93913; 🇫🇷 Montpellier, France

Site Reference ID 93916; 🇫🇷 Nice, France

Site Reference ID 93915; 🇫🇷 Paris, France

Site Reference ID 93893; 🇫🇷 Paris, France

Site Reference ID 93896; 🇫🇷 Pessac, France

Site Reference ID 93953; 🇩🇪 Bonn, Germany

Site Reference ID 93954; 🇩🇪 Frankfurt, Germany

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