Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity - Full Text View

Sponsors and Collaborators:	TNO Quality of Life Dutch Foundation for alcohol research
Information provided by:	TNO Quality of Life
ClinicalTrials.gov Identifier:	NCT00364767

Purpose

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.

Condition	Intervention
Diabetes Mellitus, Type 2 Cardiovascular Disease	Dietary Supplement: A Dietary Supplement: B

MedlinePlus related topics: Alcohol Diabetes Dietary Supplements Diets

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by TNO Quality of Life:

Primary Outcome Measures:

enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Post-prandial glycemic response [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	19
Study Start Date:	October 2004
Study Completion Date:	December 2004
Primary Completion Date:	December 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Whiskey (32 gram of alcohol/day)	Dietary Supplement: A Alcohol consumption (32 g/day) for 4 weeks
B: Placebo Comparator Water (0 gram alcohol/day)	Dietary Supplement: B Water

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)

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364767

Sponsors and Collaborators

TNO Quality of Life

Dutch Foundation for alcohol research

Investigators

Principal Investigator:

Henk FJ Hendriks, PhD.

TNO Quality of Life

More Information

Publications:

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. Epub 2007 May 11.

Responsible Party:	TNO Quality of Life ( Henk Hendriks )
Study ID Numbers:	P5805
Study First Received:	August 15, 2006
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00364767 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by TNO Quality of Life:

Moderate alcohol consumption
Fat and carbohydrate oxidative capacity
Postprandial glycemic response

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Drinking Behavior
Endocrine System Diseases
Overweight
Healthy
Alcohol Drinking

Insulin
Diabetes Mellitus, Type 2
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Ethanol

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Drinking Behavior
Diabetes Mellitus

Endocrine System Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Alcohol Drinking

ClinicalTrials.gov processed this record on May 06, 2009