Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00364767
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2006-08-15
Brief Title:
Moderate Alcohol Consumption Fat and Carbohydrate Metabolism and Insulin Sensitivity
Sponsor:
TNO
Organization:
TNO
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 vv 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
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 vv 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None