Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167115
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2005-09-09
Brief Title:
Metabolic Effects of Alcohol
Sponsor:
Bantle John P MD
Organization:
University of Minnesota
Study Overview
Official Title:
Metabolic Effects of Alcohol in the Form of Wine in Persons With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2012-07
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:
The hypotheses to be tested are 1 the use of alcohol in the form of wine with the evening meal will lower plasma glucose during the night and result in lower fasting plasma glucose the next morning 2 the chronic use of alcohol in moderation in the form of wine will have beneficial effects on plasma lipids in type 2 diabetic subjects
Detailed Description:
The use of alcohol in moderation has been associated with reduced mortality rates reduced risk of cardiovascular disease and reduced risk for type 2 diabetes However the effects of alcohol in persons with type 2 diabetes have not yet been defined Moreover the possibility of alcohol induced hypoglycemia remains a safety concern Finally little is known about the effects of alcohol on plasma lipids in people with diabetes To address these issues two substudies are proposed The first substudy will examine the acute effects of alcohol in the form of wine at supper on postprandial and nocturnal glucose levels The second substudy will examine the effects of alcohol in the form of wine consumed regularly for one month on plasma lipids
To test these hypotheses 20 type 2 diabetics will be studied In substudy 1 subjects will be admitted to the Clinical Research Center for a two day inpatient stay Blood samples for plasma glucose and serum insulin will be obtained every two hours from 500 pm to 700 am On one day subjects will recieve 8 ounces of wine with dinner On the other day subjects will recieve 8 ounces of fruit juice with dinner The primary endpoint of substudy 1 will be fasting plasma glucose In substudy 2 subjects will be asked to consume 4-8 ounces of wine in the evening for one month and to abstain from wine and alcohol containing beverages for one month Fasting blood samples will be obtained after the month of wine consumption and after the month of abstention from alcohol for measurement of fasting lipids The primary endpoint of substudy 2 will be fasting HDL cholesterol
To test these hypotheses 20 type 2 diabetics will be studied In substudy 1 subjects will be admitted to the Clinical Research Center for a two day inpatient stay Blood samples for plasma glucose and serum insulin will be obtained every two hours from 500 pm to 700 am On one day subjects will recieve 8 ounces of wine with dinner On the other day subjects will recieve 8 ounces of fruit juice with dinner The primary endpoint of substudy 1 will be fasting plasma glucose In substudy 2 subjects will be asked to consume 4-8 ounces of wine in the evening for one month and to abstain from wine and alcohol containing beverages for one month Fasting blood samples will be obtained after the month of wine consumption and after the month of abstention from alcohol for measurement of fasting lipids The primary endpoint of substudy 2 will be fasting HDL cholesterol
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Bantle1 | None | None | None |