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Metabolic Adaptations to Diabetes in African Americans

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ClinicalTrials.gov Identifier: NCT00780195
Recruitment Status : Completed
First Posted : October 27, 2008
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Procedure: glucose clamp Not Applicable

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  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Official Title: Metabolic Adaptations to Diabetes
Study Start Date : July 1998
Actual Primary Completion Date : November 2000
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. catecholamines [ Time Frame: 2 hours ]


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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

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

Responsible Party: Steve Davis, Department Chair, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00780195     History of Changes
Other Study ID Numbers: IRB # 8177
First Posted: October 27, 2008    Key Record Dates
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