Metabolic Adaptations to Diabetes in African Americans - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00780195

Purpose

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.

Condition	Intervention
Diabetes	Procedure: glucose clamp

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Active Control, Factorial Assignment
Official Title:	Metabolic Adaptations to Diabetes

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

catecholamines [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment:	16
Study Start Date:	July 1998
Estimated Study Completion Date:	June 2009
Primary Completion Date:	November 2000 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Single 2 hour hyperinsulinemic euglycemic clamp study at ~90 mg/dl.	Procedure: glucose clamp 2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)
2: Experimental Single 2 hour hyperinsulinemic hypoglycemic clamp study at ~70 mg/dl.	Procedure: glucose clamp 2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)
3: Experimental Single 2 hour hyperinsulinemic hypoglycemic clamp at ~60 mg/dl.	Procedure: glucose clamp 2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)
4: Experimental Single, 2 hour hyperinsulinemic hypoglycemic clamp at ~50 mg/dl.	Procedure: glucose clamp 2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780195

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Stephen N. Davis, MD

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:	IRB # 8177
Study First Received:	October 24, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00780195
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

hypoglycemia
African Americans

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

ClinicalTrials.gov processed this record on January 16, 2009