NCT00373854

Brief Summary

Hypothesis: Low blood sugar (hypoglycemia) decreases function of the lining of the blood vessels in normal humans. This study is designed to explore how hypoglycemia affects the function of the blood vessel lining. This will be determined by measuring blood flow to the arm before and after occlusion of flow. Blood vessel function will be measured before induction of hypoglycemia, during insulin induced hypoglycemia, and after recovery from hypoglycemia. A second study will be done but without hypoglycemia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2005

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

September 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

September 7, 2006

Last Update Submit

June 6, 2016

Conditions

Hypoglycemia

Keywords

HypoglycemiaEndothelial function

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy adults

You may qualify if:

  • Age 18-40 years
  • BMI \<27 kg/m2

You may not qualify if:

  • Pregnancy
  • Systolic blood pressure \>140 mmHg
  • Diastolic Blood pressure \>90 mg/dl
  • Spot daytime urine microalbumin concentration \> 20 μg/mg creatinine
  • Past or present history of chronic disease (e.g. cancer, hypertension, cardiovascular disease, chronic inflammatory disease) other than diabetes in type 1 diabetic subjects.
  • Use of non prescription medications in the past 3 days
  • Use of prescription medications in the past 2 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Robert P Hoffman, MD

    Ohio State University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Study Start

September 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

June 8, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Observational study

Locations

US(1)