Metabolic Adaptations to Diabetes in African Americans

Diabetes Clinical Trial

Official title:

Metabolic Adaptations to Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780195
• Other study ID #: IRB # 8177
• Status: Completed
• Phase: N/A
• First received: October 24, 2008
• Last updated: December 10, 2014
• Start date: July 1998
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2010
• Est. primary completion date: November 2000
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Diabetes

Intervention

Procedure:
• glucose clamp
2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)
• glucose clamp
2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)
• glucose clamp
2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)
• glucose clamp
2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catecholamines		2 hours	No