NCT00780195

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Jul 1998

Longer than P75 for not_applicable diabetes

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2000

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2008

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

October 24, 2008

Last Update Submit

December 10, 2014

Conditions

Diabetes

Keywords

hypoglycemiaAfrican Americans

Outcome Measures

Primary Outcomes (1)

  • catecholamines

    2 hours

Study Arms (4)

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

glucose clampPROCEDURE

2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)

1

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Prior or current history of poor health
  • Abnormal results following blood and physical examination
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusHypoglycemia

Interventions

Glucose Clamp Technique

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Stephen N. Davis, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Chair

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 27, 2008

Study Start

July 1, 1998

Primary Completion

November 1, 2000

Study Completion

December 1, 2010

Last Updated

December 11, 2014

Record last verified: 2014-12