- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00566592
The Effect of Ethanol on Overnight Glucose Regulation in Type 2
The Effect of Ethanol on Overnight Glucose Regulation in Type 2 Diabetes Mellitus
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87131
- University of New Mexico Clincal and Translational Science Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: All type 2 diabetes subjects will be aged 50 to 75 years and will have carried the diagnosis of diabetes according to standard criteria and will be receiving insulin therapy alone or in combination with oral diabetes medications for at least 6 months. To exclude subjects with type 1 diabetes, all patients will be anti-GAD antibody negative and will retain the ability to secrete some nominal level of c-peptide in response to stimulation (i.e.- at least 2 ng/ml after ingesting Boost Plus). All subjects will be mentally fit to give informed consent. Nondiabetic control subjects will meet similar inclusion criteria (except for diabetes and hemoglobin A1C criteria). Control subjects will be matched as a group for age, gender and BMI. Finally, control subjects will undergo a standard 75 gram Oral Glucose Tolerance Test to assure the presence of normal glucose tolerance (142).
Exclusion Criteria: Exclusion criteria for all study subjects will include the existence of severe cardiovascular, hepatic or renal disease, or current malignancy as determined by the screening evaluation. Subjects with a past or current history of drug or alcohol abuse will also be excluded from study, as will subjects with a previously diagnosed seizure disorder, subjects with sleep apnea by medical history or as demonstrated during the accommodation sleep study night, subjects with diabetic gastroparesis, or subjects receiving current treatment medications that interfere with glucose homeostasis other than for diabetes therapy (e.g.- glucocorticoids, orlistat). Because of the known adverse effects of ethanol on unborn children, current intrauterine pregnancy will exclude patients from study. A body mass index greater than 36 kg/m2 will also be exclusionary. Additionally, subjects with a score of more than eight points on the Alcohol Use Disorders Identification Test (AUDIT) will be excluded from study.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Oral ethanol, overnight
|
Oral ethanol before bedtime to achieve approximate BAL of 0.08%
|
Experimental: 2
IV ethanol, overnight
|
IV ethanol before bedtime to achieve approximate BAL of 0.08%
|
Placebo Comparator: 3
Placebo, overnight
|
Oral Placebo before bedtime to achieve approximate BAL of 0.00%
Oral Placebo to achieve approximate daytime BAL of 0.00%
|
Placebo Comparator: 4
Placebo, daytime
|
Oral Placebo before bedtime to achieve approximate BAL of 0.00%
Oral Placebo to achieve approximate daytime BAL of 0.00%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of glucose recovery from hypoglycemia.
Time Frame: Hours
|
Hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hormone and substrate concentrations
Time Frame: Hours
|
Hours
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mark R Burge, MD, University of New Mexico
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK61990 (completed)
- DK061990
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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