Diabetes Mellitus, Type 2 Clinical Trial
Official title:
The Effect of Moderate Alcohol Consumption on Markers of Oxidative Phosphorylation and Lipid Oxidation and on Postprandial Glycemic Control in Healthy, Lean and Overweight, Young Men
Moderate alcohol consumption is associated with a decreased risk of diabetes type 2. This
association could be mediated by an improvement of insulin sensitivity with moderate alcohol
consumption. Patients with diabetes type 2 or impaired glucose tolerance often may have
decreased fat oxidative capacity or oxidative phosphorylation in tissue such as muscle. This
could lead to accumulation triglyceride storage in muscle, which could interfere with
insulin signaling. Whether such mechanism can also play a role with moderate alcohol
consumption is unknown and will be investigated in this study.
In addition, moderate alcohol consumption with a meal can lead to delayed hypoglycemia in
type 1 diabetes patients. How moderate alcohol consumption affects postprandial glycemic
response in healthy subjects is unknown. This is a secondary objective of this trial.
To investigate the effect of moderate alcohol consumption on
- enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in
skeletal muscle
- transporters of fatty acids and glucose in fat tissue
- post-prandial glycemic response in healthy, lean or overweight, young men
Design : Open, randomized, partially diet-controlled, placebo controlled cross-over design
Participants
- Description : Healthy, lean and overweight young (18-40 years) men
- Number : 20
Study substances
- Test substance : 100 ml whiskey (Famous Grouse, 40% v/v alcohol: ≈ 32 g alcohol)
- Reference substance : 100 ml mineral water (Spa blauw)
Duration: 2 treatment periods of 4 weeks (28 days)
Test parameters:
- Muscle biopsy for activity of 3-hydroxy fatty-acyl CoA dehydrogenase, citrate synthase,
cytochrome c oxidase
- Postprandial glycemic response (glucose, insulin, GLP-1, GLP-2, GIP, glucagon, FFA
etc.)
- Insulin sensitivity and related factors (oral glucose tolerance test, adiponectin,
HbA1c)
- Liver enzymes (safety)
- Body weight
- Urinary ethyl glucuronide (compliance)
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
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