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Metabolic Adaptations to Diabetes in African Americans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00780195
First Posted: October 27, 2008
Last Update Posted: December 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University
  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 (Participant)
Official Title: Metabolic Adaptations to Diabetes

Resource links provided by NLM:


Further study details as provided by Steve Davis, Vanderbilt University:

Primary Outcome Measures:
  • catecholamines [ Time Frame: 2 hours ]

Enrollment: 16
Study Start Date: July 1998
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00780195


Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Stephen N. Davis, MD Vanderbilt University
  More Information

Responsible Party: Steve Davis, Department Chair, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00780195     History of Changes
Other Study ID Numbers: IRB # 8177
First Submitted: October 24, 2008
First Posted: October 27, 2008
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Steve Davis, 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