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Metabolic Adaptations to Diabetes in African Americans

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Vanderbilt University

Status

Completed

Conditions

Diabetes

Treatments

Procedure: glucose clamp

Study type

Interventional

Funder types

Other

Identifiers

NCT00780195
IRB # 8177

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

16 participants in 4 patient groups

1
Experimental group
Description:
Single 2 hour hyperinsulinemic euglycemic clamp study at \~90 mg/dl.
Treatment:
Procedure: glucose clamp
Procedure: glucose clamp
Procedure: glucose clamp
Procedure: glucose clamp
2
Experimental group
Description:
Single 2 hour hyperinsulinemic hypoglycemic clamp study at \~70 mg/dl.
Treatment:
Procedure: glucose clamp
Procedure: glucose clamp
Procedure: glucose clamp
Procedure: glucose clamp
3
Experimental group
Description:
Single 2 hour hyperinsulinemic hypoglycemic clamp at \~60 mg/dl.
Treatment:
Procedure: glucose clamp
Procedure: glucose clamp
Procedure: glucose clamp
Procedure: glucose clamp
4
Experimental group
Description:
Single, 2 hour hyperinsulinemic hypoglycemic clamp at \~50 mg/dl.
Treatment:
Procedure: glucose clamp
Procedure: glucose clamp
Procedure: glucose clamp
Procedure: glucose clamp

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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