Metabolic Adaptations to Diabetes in African Americans | NCT00780195

Studies
Metabolic Adaptations to Diabetes in African Americans

NCT00780195

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Dec 11, 2014Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Diabetes

Interventions

glucose clamp
glucose clamp
glucose clamp
glucose clamp

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1998

Primary Completion Date

Nov 2000Actual

Completion Date

Dec 2010Actual

First Submitted Date

Oct 24, 2008

First Submission Date that Met QC Criteria

Oct 24, 2008

First Posted Date

Oct 27, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2014

Last Update Posted Date

Dec 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Single 2 hour hyperinsulinemic euglycemic clamp study at ~90 mg/dl.	Procedure: glucose clamp
2	Experimental	Single 2 hour hyperinsulinemic hypoglycemic clamp study at ~70 mg/dl.	Procedure: glucose clamp
3	Experimental	Single 2 hour hyperinsulinemic hypoglycemic clamp at ~60 mg/dl.	Procedure: glucose clamp
4	Experimental	Single, 2 hour hyperinsulinemic hypoglycemic clamp at ~50 mg/dl.	Procedure: glucose clamp

Interventions

Name	Type	Description	Arm Group Labels	Other Names
glucose clamp	Procedure	2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)	1

Measure	Description	Time Frame
catecholamines		2 hours

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen N. Davis, MD	Vanderbilt University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D007003	Hypoglycemia

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015309	Glucose Clamp Technique

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided