NCT00364767

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Oct 2004

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2006

Completed
Last Updated

May 23, 2008

Status Verified

May 1, 2008

Enrollment Period

2 months

First QC Date

August 15, 2006

Last Update Submit

May 22, 2008

Conditions

Diabetes Mellitus, Type 2Cardiovascular Disease

Keywords

Moderate alcohol consumptionFat and carbohydrate oxidative capacityPostprandial glycemic response

Outcome Measures

Primary Outcomes (1)

  • enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in skeletal muscle

    4 weeks

Secondary Outcomes (2)

  • Post-prandial glycemic response

    4 weeks

  • insulin sensitivity (oral glucose tolerance test) and related factors (adiponectin, HbA1c)

    4 weeks

Study Arms (2)

A

EXPERIMENTAL

Whiskey (32 gram of alcohol/day)

Dietary Supplement: A

B

PLACEBO COMPARATOR

Water (0 gram alcohol/day)

Dietary Supplement: B

Interventions

ADIETARY_SUPPLEMENT

Alcohol consumption (32 g/day) for 4 weeks

A
BDIETARY_SUPPLEMENT

Water

B

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1007/s00125-007-0699-8. Epub 2007 May 11.

    PMID: 17492425RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular DiseasesPlatelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Henk FJ Hendriks, PhD.

    TNO

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2006

First Posted

August 16, 2006

Study Start

October 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

May 23, 2008

Record last verified: 2008-05