Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364767
• Other study ID #: P5805
• Status: Completed
• Phase: N/A
• First received: August 15, 2006
• Last updated: May 22, 2008
• Start date: October 2004
• Est. completion date: December 2004

Study information

• Verified date: May 2008
• Source: TNO
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Drinking
• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2

Intervention

Dietary Supplement:
• A
Alcohol consumption (32 g/day) for 4 weeks
• B
Water

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
TNO	Dutch Foundation for alcohol research

References & Publications (1)

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

Outcome

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