Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-27 @ 4:33 AM
Study NCT ID:
NCT00364767
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2006-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity
Sponsor:
TNO
Organization:
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% 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)
* 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)
Study Oversight
Has Oversight DMC:
True
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?: