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Metabolic Adaptations to Diabetes in African Americans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00780195
First received: October 24, 2008
Last updated: October 12, 2010
Last verified: October 2010
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Official Title: Metabolic Adaptations to Diabetes

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

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: December 2010
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Single 2 hour hyperinsulinemic euglycemic clamp study at ~90 mg/dl.
 Procedure: glucose clamp
2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)
Experimental: 2
Single 2 hour hyperinsulinemic hypoglycemic clamp study at ~70 mg/dl.
 Procedure: glucose clamp
2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)
Experimental: 3
Single 2 hour hyperinsulinemic hypoglycemic clamp at ~60 mg/dl.
 Procedure: glucose clamp
2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)
Experimental: 4
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

No publications provided

Responsible Party: Stephen N. Davis, MD, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00780195     History of Changes
Other Study ID Numbers: IRB # 8177
Study First Received: October 24, 2008
Last Updated: October 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
hypoglycemia
African Americans

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013