Metabolic Adaptations to Diabetes in African Americans
December 10, 2014 updated by: Steve Davis, Vanderbilt University
Metabolic Adaptations to Diabetes
We do not know why diabetic patients cannot protect themselves against low blood sugar.
Therefore, in this study, we will perform a comprehensive assessment of the body's response to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve signals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Morning and afternoon hypoglycemic episodes of 70, 60, or 50 mg/dl produce increased blunting of subsequent counterregulation dependent upon the depth of preceding hypoglycemia.
We wanted to test this hypothesis in healthy African American individuals to determine if there is a difference in their responses to varying depths of hypoglycemia.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy males and females aged 18-40 yrs with no family history of diabetes mellitus.
- All prospective volunteers will have routine blood tests to screen for biochemical, hormonal and hematological abnormalities.
- Female volunteers will also undergo an HCG urine pregnancy test.
Exclusion Criteria:
- Prior or current history of poor health
- Abnormal results following blood and physical examination
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Single 2 hour hyperinsulinemic euglycemic clamp study at ~90 mg/dl.
|
2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)
|
|
Experimental: 2
Single 2 hour hyperinsulinemic hypoglycemic clamp study at ~70 mg/dl.
|
2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)
|
|
Experimental: 3
Single 2 hour hyperinsulinemic hypoglycemic clamp at ~60 mg/dl.
|
2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)
|
|
Experimental: 4
Single, 2 hour hyperinsulinemic hypoglycemic clamp at ~50 mg/dl.
|
2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)
2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
catecholamines
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 1998
Primary Completion (Actual)
November 1, 2000
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
October 24, 2008
First Submitted That Met QC Criteria
October 24, 2008
First Posted (Estimate)
October 27, 2008
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
December 10, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB # 8177
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.