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Optimizing the beneficial health effects of exercise for diabetes: focus on the liver!

Completed
Conditions
type 2 diabetes mellitus
10018424
10019654
diabetes
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
Inclusion Criteria

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)

Exclusion Criteria

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
NameTimeMethod
<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
NameTimeMethod
<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>
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