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Clinical Trial Summary

A body of epidemiologic studies show that moderate alcohol consumption is associated with a protective effect against type 2 diabetes. The importance of both insulin sensitivity and insulin secretion in the pathogenesis of glucose intolerance and diabetes type 2 is widely recognized. Clinical studies show improved insulin sensitivity after a period of alcohol consumption compared to abstention. However, postprandial insulin secretion and beta-cell function after a period of moderate alcohol consumption have scarcely been addressed in published literature.

When consumed as an aperitif or with a meal, alcohol is generally expected to stimulate appetite and food intake and thus might be a risk factor for over consumption and obesity. However the physiological mechanisms for this observed effect are not well understood. Furthermore, previous studies lacked a link between physiological parameters and subjective parameters of satiety.


Clinical Trial Description

Objective:

Primary objectives are to study the effects of moderate alcohol consumption on

- Postprandial insulin secretion and pancreatic beta-cell function

- Physiological and subjective parameters related to satiety and appetite

Secondary objectives are to study the effects of moderate alcohol consumption on

- Miscellaneous markers of glucose homeostasis and insulin sensitivity

- Kinetics of alcohol-induced increase of adiponectin

A tertiary objective is to study the effects of moderate alcohol consumption on

- Gene expression in subcutaneous adipose tissue in normal-weight pre menopausal women with normal fasting plasma glucose.

Study design: Randomized, partially controlled, open label, cross-over study with a one week wash-out preceding each treatment period

Study population: 24 apparently healthy pre menopausal Caucasian women with fasting blood glucose <6.1 mmol/L, aged 20 - 44 years at inclusion of the study, with a BMI of 19 - 25 kg/m2, who use oral contraceptives will participate in the study.

Intervention: Participants will drink daily a test substance for three weeks (2 cans of Amstel beer per day; 66 cL ~ 26 gram alcohol) followed by a reference substance (2 cans of Amstel alcohol-free beer per day; 66 cL < 0.5 gram of alcohol) for three weeks or vice versa. Both treatments are preceded by a one-week wash-out period in which no alcohol is consumed. ;


Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00524550
Study type Interventional
Source TNO
Contact
Status Completed
Phase N/A
Start date August 2007
Completion date November 2007

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