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.
Status | Completed |
Enrollment | 19 |
Est. completion date | December 2004 |
Est. primary completion date | December 2004 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Healthy men aged between 18 and 40 years - Lean subjects BMI 18.5-25 kg/m2 and overweight/obese subjects BMI >27 kg/m2 (including 18.5, 25 and 27) - Alcohol consumption between 7 and 28 units/week (including 7 and 28) Exclusion Criteria: - Smoking - Family history of alcoholism - History of medical or surgical events that may significantly affect the study outcome, particularly metabolic or endocrine disorders and gastrointestinal disorders - Recent blood donation - More than 8 hours/week of intense exercise - Blood haemoglobin concentration below 8.4 mmol/l - Allergic to betadine or lidocaine. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
TNO | Dutch Foundation for alcohol research |
Beulens JW, van Loon LJ, Kok FJ, Pelsers M, Bobbert T, Spranger J, Helander A, Hendriks HF. The effect of moderate alcohol consumption on adiponectin oligomers and muscle oxidative capacity: a human intervention study. Diabetologia. 2007 Jul;50(7):1388-92 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle | 4 weeks | No | |
Secondary | Post-prandial glycemic response | 4 weeks | No | |
Secondary | insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c) | 4 weeks | No |
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