Monitoring of Hepatic Fat Metabolism Using Magnetic Resonance Methods
NCT ID: NCT03680248
Last Updated: 2020-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2016-04-26
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Healthy subjects, Fat
non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load intervention
Fat
Subjects will consume dairy cream (150 g of fat) at time 0 hours.
Steatosis, Fat
non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load intervention
Fat
Subjects will consume dairy cream (150 g of fat) at time 0 hours.
Healthy subjects, Fasting
non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fasting
Fasting
Subjects will fast throughout the experiment.
Steatosis, Fasting
non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fasting
Fasting
Subjects will fast throughout the experiment.
Healthy subjects, Fat+Glucose
non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + glucose administration
Fat+Glucose
Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of glucose.
Steatosis, Fat+Glucose
non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + glucose administration
Fat+Glucose
Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of glucose.
Healthy subjects, Glucose
non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - glucose administration
Glucose
Subjects will drink herbal tea containing 50 g of glucose at times 0, 2 and 4 hours.
Steatosis, Glucose
non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - glucose administration
Glucose
Subjects will drink herbal tea containing 50 g of glucose at times 0, 2 and 4 hours.
Healthy subjects, Fat+Fructose
non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - high-fat load + fructose administration
Fat+Fructose
Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of fructose.
Steatosis, Fat+Fructose
non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - high-fat load + fructose administration
Fat+Fructose
Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of fructose.
Healthy subjects, Fructose
non-obese insulin-sensitive male volunteers with normal hepatic fat content (less than 5% of liver fat) - fructose administration
Fructose
Subjects will drink herbal tea containing 50 g of fructose at times 0, 2 and 4 hours.
Steatosis, Fructose
non-obese non-diabetic male volunteers with hepatosteatosis (more than 5% of liver fat) - fructose administration
Fructose
Subjects will drink herbal tea containing 50 g of fructose at times 0, 2 and 4 hours.
Interventions
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Fat
Subjects will consume dairy cream (150 g of fat) at time 0 hours.
Fasting
Subjects will fast throughout the experiment.
Fat+Glucose
Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of glucose.
Glucose
Subjects will drink herbal tea containing 50 g of glucose at times 0, 2 and 4 hours.
Fat+Fructose
Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of fructose.
Fructose
Subjects will drink herbal tea containing 50 g of fructose at times 0, 2 and 4 hours.
Eligibility Criteria
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Inclusion Criteria
* normal glycated hemoglobin
* normal aspartate aminotransferase (AST)
* normal alanine aminotransferase (ALT)
Exclusion Criteria
* use of pharmacological agents affecting insulin sensitivity
* use of pharmacological agents affecting lipid metabolism
* inability to undergo 1H-MRS examination
18 Years
65 Years
MALE
Yes
Sponsors
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Institute for Clinical and Experimental Medicine
OTHER_GOV
Responsible Party
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Jan Kovar
Head of the laboratory
Principal Investigators
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Milan Hajek, DSc
Role: PRINCIPAL_INVESTIGATOR
Institute for Clinical and Experimental Medicine
Locations
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Institute for Clinical and Experimental Medicine
Prague, , Czechia
Countries
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References
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Dusilova T, Kovar J, Drobny M, Sedivy P, Dezortova M, Poledne R, Zemankova K, Hajek M. Different acute effects of fructose and glucose administration on hepatic fat content. Am J Clin Nutr. 2019 Jun 1;109(6):1519-1526. doi: 10.1093/ajcn/nqy386.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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G285
Identifier Type: -
Identifier Source: org_study_id
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