No registrations found.
ID
Source
Brief title
Health condition
Type 2 diabetes (T2DM), Insulin resistance, Non-Alcoholic Fatty Liver Disease (NAFLD)
Type 2 diabetes, insuline resisstentie en leververvetting
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter is the difference in lipid accumulation and insulin sensitivity after a switch from a low-fat diet to a high-fat diet compared to the control group, which stays on a low-fat diet.
Secondary outcome
As secondary endpoints differences the time-course of lipid accumulation and the relationship between the tissue parameter lipid ccumulation and the functional outcome parameter insulin resistance are considered.
Background summary
N/A
Study objective
A high fat-diet can influence IMCL and IHL in rodents and in humans, the time-course of peripheral lipid accumulation in liver and skeletal muscle while switching from a low-fat to a high-fat diet is unknown.
Study design
T=1, T=21 and T=42 (days).
And additional liver lipid accumulation measurement in HF-group on t=28.
Intervention
Both groups, the control group and the experimental group, will start with 3 weeks on a low-fat diet which will deliver 15 Energy% of energy as protein, 65 En% as CHO and 20 En% as fat. After these 3weeks the experimental group will switch to a high-fat diet (15 En% protein, 30 En% CHO and 55% En% fat). wheras the control group stays on the low-fat diet.
Department of Human Biology
Maastricht University Medical Center
Patrick Schrauwen
Department of Human Biology
Maastricht University Medical Center
Maastricht 6200 MD
The Netherlands
+31(0)43-388 15 02
p.schrauwen@hb.unimaas.nl
Department of Human Biology
Maastricht University Medical Center
Patrick Schrauwen
Department of Human Biology
Maastricht University Medical Center
Maastricht 6200 MD
The Netherlands
+31(0)43-388 15 02
p.schrauwen@hb.unimaas.nl
Inclusion criteria
1. Male sex;
2. Age 40-65 years;
3. BMI 25-35 kg/m2;
4. Sedentary;
5. Stable dietary habits;
6. Healthy.
Exclusion criteria
1. Current use of medication that is known to interfere with the results of the study;
2. Consuming more than 20 g of alcohol per day (± 2 units);
3. Serum-γ-glutamyltranspeptidase level > 70 IU/L;
4. A history of cardiovascular disease like congestive heart failure or acute myocardial infarction;
5. Plasma triacylglycerol > 4.5 mmol/L;
6. Familial hypercholesterolemia;
7. A history of liver disease;
8. Unstable body weight (weight gain or loss > 3 kg in the past three months);
9. Abuse of drugs;
10. Participation in another biomedical study within 1 month prior to the screening visit;
11. Impossible or difficult venipuncture during screening;
12. A fasting glucose above 7.0 mmol/L (13);
13. A contraindication to MRI scanning. These contraindications include patients with the following devices:
a. Central nervous system aneurysm clips;
b. Implanted neural stimulator;
c. Implanted cardiac pacemaker or defibrillator;
d. Cochlear implant;
e. Ocular foreign body (e.g. metal shavings);
f. Insulin pump;
g. Metal shrapnel or bullet;
h. Or metal containing corpora aliena in the eye of brains.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2019 |
| NTR-old | NTR2136 |
| Other | MEC : 07-3-028 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |