Clinical Trial: Study to Assess the Effect of Cannabidiol on Liver Fat Levels in Subjects With Fatty Liver Disease.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised, Partially-blind, Placebo-controlled, Pilot, Dose-ranging Study to Assess the Effect of Cannabidiol on Liver Fat Levels in Subjects With Fatty Liver Disease
Brief Summary: The purpose of this study is to assess the effect of cannabidiol (CBD) on liver triglyceride (liver fat) in subjects with fatty liver disease.
Detailed Summary:
This 10 week (2-10 day screening, eight week treatment period and one week follow-up), randomized, partially-blind study will assess the effect of CBD in subjects with raised liver triglycerides (liver fat ≥ 5%).
Eligible subjects will enter the study at a Screening Visit (Visit 1, Day -10 to -2) and commence a two to ten day screening period, before returning for a baseline visit (Visit 2, Day 1).
During the fasted Screening Visit, study-related observations will include: informed consent, demographics, medical history, physical examination, electrocardiogram (ECG), vital signs, weight, height and concomitant medications.
Subjects will have the following assessments performed:
- Fasting lipid profile blood sample
- Fasting plasma glucose, HbA1c & fasting serum insulin
- Safety blood tests (haematology and biochemistry)
- Urinalysis (including drugs of abuse screen)
- CAGE Questionnaire to assess alcohol dependency
- Body weight will be measured and BMI calculated
- Pregnancy test (if appropriate)
- Liver triglyceride content (Magnetic Resonance Spectroscopy (MRS)) scan unless there is documented history of a liver fat content equal to or above 5% as measured by Magnetic Resonance Imaging (MRI)/MRS or a biopsy within the last two months prior to this screening visit. Where subjects (and/or carers) feel the scan poses a significant burden (in addition to the other visit procedures), the fasted scan may be undertaken separately with the remaining visit procedur
Sponsor: GW Research Ltd
Current Primary Outcome: Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels [ Time Frame: After 56 days of treatment ]
Liver triglyceride levels (%) were measured by MRI/MRS scanning and the change from baseline to end of treatment in group mean levels were investigated. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
Original Primary Outcome: Liver triglyceride levels in subjects with fatty liver [ Time Frame: Following 56 days of treatment ]
Relationship between liver triglyceride levels and dose of cannabidiol will be explored graphically.
Current Secondary Outcome:
- Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels [ Time Frame: After 56 days of treatment ]A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels [ Time Frame: After 56 days of treatment ]A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline (i.e. a positive value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels [ Time Frame: After 56 days of treatment ]A fasting blood sample was obtained for the measurement of LDL-C. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio [ Time Frame: After 56 days of treatment ]A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline (i.e. a positive value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels [ Time Frame: After 56 days of treatment ]A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels [ Time Frame: After 56 days of treatment ]A fasting blood sample was obtained for the measurement of fasting plasma glucose. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI) [ Time Frame: After 56 days of treatment ]Individual subject's BMIs were calculated by dividing mass (kg) by height (m2). A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Body Weight [ Time Frame: After 56 days of treatment ]Body weight (kg) was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio [ Time Frame: After 56 days of treatment ]The waist-to-hip ratio was calculated at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Neck Measurement [ Time Frame: After 56 days of treatment ]The neck circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Waist Measurement [ Time Frame: After 56 days of treatment ]Waist circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Hip Measurement [ Time Frame: After 56 days of treatment ]Hip circumference was measured at baseline and the end of treatment. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral) [ Time Frame: After 56 days of treatment ]Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary) [ Time Frame: After 56 days of treatment ]Skin fold thickness measurements were the mean of three measurements per site calculated for each subject. If one or more measurements were missing for a site, then the mean was calculated over the available measurement(s) for that site. A reduction from baseline (i.e. a negative value) indicates an improvement in condition.
- Change From Baseline to the End of Tr
Original Secondary Outcome:
- Body weight and BMI [ Time Frame: After 56 days of treatment ]
- Adipose tissue distribution [ Time Frame: After 56 days of treament ]
- Glucose control [ Time Frame: After 56 days of treatment ]Fasting plasma glucose levels
- Insulin sensitivity [ Time Frame: After 56 days of treatment ]Fasting serum insulin levels
- Safety and tolerability assessments [ Time Frame: Throughout ]
Information By: GW Research Ltd
Dates:
Date Received: January 26, 2011
Date Started: February 2011
Date Completion:
Last Updated: September 9, 2014
Last Verified: September 2014
- Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels [ Time Frame: After 56 days of treatment ]
