Optimizing the beneficial health effects of exercise for diabetes: focus on the liver!
- Conditions
- type 2 diabetes mellitus1001842410019654diabetes
- Registration Number
- NL-OMON39037
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 114
All subjects:
Male sex
Age 40-70 years
BMI 27-35 kg/m2
Stable dietary habits
sedentary: no participation in any kind of sports for at least 2 years
For diabetic patients only:
Must be on sulphonylurea or metformin therapy for at least 6 months with constant dose for at least 2 months, or on a dietary treatment for at least 6 months
Well-controled diabetes: fasting plasma glucose concentration * 7.0 mmol/l and < 10.0 mmol/l at the time of screening.;For subjects with non-alcoholic fatty liver disease:
Liver fat content * 5,56%
Fasting plasma concentration must be < 7.0 mmol/l ;For control subjects:
Liver fat content < 5,56%
Normoglycemic according to the WHO criteria (OGTT)
Female sex
Unstable body weight (weight gain or loss > 3 kg in the past three months)
Participation in an intensive weight-loss program or in a exercise program during
the last year before the start of the study.
(Low) physical activity (more than 30 minutes (low) physical activity per week)
Active cardiovascular disease. (This will be determined by quenstionnaires and by screening on medication. Furthermore, all subjects
will undergo a physical examination by a medical doctor).
Chronic renal dysfunction (creatinine > 2 increased (normal values: 64-104 µmol/l))
Use of Beta-blockers
Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
Haemoglobin < 7.5 mmol/l (anemia)
Blood donor
Use of medication know to interfere with glucose homeostasis (i.e. corticosteroids), except for diabetics
Use of anti-trombotic medication
Claustrophobia and metal implants (with respect to MRI)
Abuse of drugs
Participation in another biomedical study within 1 month before the first screening
visit
Alcohol abuse (> 3 units (1unit = 10 gram ethanol) per day);For diabetic patients:
Severe diabetes which requires application of insulin or patients with diabetes-related complications;For controls:
Liver disease or liver dysfunction (ALAT > 2.5 x increased (normal values: 5 - 60 U/L))
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are the differences in values for intrahepatic lipid<br /><br>content and mitochondrial liver function from baseline to endpoint in the same<br /><br>group, as well as the differences in effect of the intervention between the<br /><br>different groups.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary objective is to investigate if the beneficial effects of exercise<br /><br>training on metabolic risk markers are dependent on the reduction of liver fat.<br /><br>Furthermore, we will measure if the reduction of liver fat and improvement of<br /><br>liver metabolism correlates with improvement of lipid metabolism in the<br /><br>skeletal muscle.</p><br>