Status:
COMPLETED
Elevated Circulating FFA and Intrahepatic Lipid Content
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Diabetes
Hepatic Steatosis
Eligibility:
MALE
40-65 years
Phase:
NA
Brief Summary
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 in...
Detailed Description
In the Netherlands and worldwide, the number of individuals suffering from type 2 diabetes mellitus is rising steadily. As a consequence, a dramatic increase in diabetes-related morbidity and mortalit...
Eligibility Criteria
Inclusion
- Male sex
- Age 40-65 years
- Overweight/obese, BMI 25-35 kg/m2
- Healthy
- Stable dietary habits
- No medication use
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01177332
Start Date
April 1 2010
End Date
June 1 2013
Last Update
November 11 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Human Biology, Maastricht University
Maastricht, Netherlands, 6200 MD