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Disorders of Systemic Glucose Balance

Primary Purpose

Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Controlled hypoglycemia using insulin
formula meal
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypoglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients with suspected hypoglycemia Healthy subjects (controls) Absence of known macrovascular disease or of known CNS disease by medical history, physical examination or ECG (exclusions for induced hypoglycemia) Ability to give informed consent

Sites / Locations

  • Washington University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 18, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00006508
Brief Title
Disorders of Systemic Glucose Balance
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)

4. Oversight

5. Study Description

Brief Summary
We wish to identify people with hypoglycemia (low blood sugar) and ultimately determine why the blood sugar levels are so low. To do so, we will contrast the responses of patients suspected to have hypoglycemia with those of healthy subjects during standardized tests. Those tests may include: 1) a controlled hypoglycemia produced by administration of insulin, a blood sugar-lowering hormone, and sugar, 2) a formula meal, and 3) a period of up to 72 hours without food.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Controlled hypoglycemia using insulin
Intervention Type
Procedure
Intervention Name(s)
formula meal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with suspected hypoglycemia Healthy subjects (controls) Absence of known macrovascular disease or of known CNS disease by medical history, physical examination or ECG (exclusions for induced hypoglycemia) Ability to give informed consent
Facility Information:
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

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Disorders of Systemic Glucose Balance

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