NCT00167115

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

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

Timeline
Completed

Started Dec 2004

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

9 months

First QC Date

September 9, 2005

Last Update Submit

July 9, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

AlcoholType 2 diabetes mellitusPlama glucoseHDL cholesterol

Outcome Measures

Primary Outcomes (2)

  • Fasing plasma glucose

  • Fasting plasma HDL cholesterol

Secondary Outcomes (1)

  • Episodes of hypoglycemia

Interventions

AlcoholDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes HbA1c 6.0-8.0% age \> 40 years

You may not qualify if:

  • History of alcoholism or alcohol abuse liver disease blood pressure \> 150/90

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • John Bantle, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

December 1, 2004

Primary Completion

September 1, 2005

Study Completion

September 1, 2005

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

US(1)