Diabetes Clinical Trial
Official title:
Effects of Acute Elevation of Circulating Fatty Acids on Hepatic Lipid Accumulation and Metabolism in Healthy Overweight and Obese Men
There is increasing evidence that hepatic lipid content (IntraHepatic Lipid, IHL) markedly increases the risk of metabolic complications, including insulin resistance and cardiovascular events. The investigators hypothesize that the liver is passively taking up free fatty acids (FFA) when the availability is high, thereby leading to an increased storage. To test this hypothesis, the investigators want to manipulate FFA levels, by means of a fasted exercise and recovery protocol, and monitor IHL content and hepatic Adenosine triphosphate (ATP) and inorganic phosphate (Pi) concentrations.
Status | Completed |
Enrollment | 34 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 40 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male sex - Age 40-65 years - Overweight/obese, BMI 25-35 kg/m2 - Healthy - Stable dietary habits - No medication use Exclusion Criteria: - Female sex - Fasting plasma glucose >6.1 mmol/l - Haemoglobin <7.8 mmol/l - Engagement in programmed exercise > 2 hours total per week - Elevated liver enzymes: ALAT > 45 U/L, ASAT > 35 U/L, ALP> 140 U/L, Gamma-GT > 70 U/L - Hypertension: blood pressure > 140 mmHg systolic or 90 mmHg diastolic - First degree relatives with history of liver disease and diabetes mellitus - Any medical condition requiring treatment and/or medication use - Alcohol consumption of more than 20 g per day (± 2 units) - Unstable body weight (weight gain or loss > 3 kg in the past three months) - Participation in another biomedical study within 1 month prior to the screening visit - Contraindications for MRI scan |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Human Biology, Maastricht University | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intrahepatic lipid content (IHL) and hepatic ATP and PI concentrations | After a baseline MRI/MRS-scan, subjects will cycle for two hours, immediately after cycling another MRI/MRS-scan will be performed and again four hours post exercise. The baseline and the 4-hour post exercise MRI/MRS scans take about 1.5 hour, including both determination of IHL content, by 1H-MRS, and hepatic ATP and Pi concentrations, by 31P-MRS. The MRI/MRS scan performed directly after exercise will take about 45 min, because here only the IHL content will be determined. | Day 1 | No |
Primary | Intrahepatic lipid content (IHL) and hepatic ATP and PI concentrations | After a baseline MRI/MRS-scan, subjects will cycle for two hours, immediately after cycling another MRI/MRS-scan will be performed and again four hours post exercise. The baseline and the 4-hour post exercise MRI/MRS scans take about 1.5 hour, including both determination of IHL content, by 1H-MRS, and hepatic ATP and Pi concentrations, by 31P-MRS. The MRI/MRS scan performed directly after exercise will take about 45 min, because here only the IHL content will be determined. | Day 8 | No |
Secondary | Substrate oxidation and blood plasma levels of FFA, triglycerides, glucose and catecholamines | Day 1 | No | |
Secondary | Substrate oxidation and blood plasma levels of FFA, triglycerides, glucose and catecholamines | Day 8 | No |
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