Study of How Low Blood Sugar Affects the Way Blood Vessels Work

Hypoglycemia Clinical Trial

Official title:

Hypoglycemia and Endothelial Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373854
• Other study ID #: Endo 208
• Status: Completed
• Phase: N/A
• First received: September 7, 2006
• Last updated: June 6, 2016
• Start date: September 2005
• Est. completion date: September 2006

Study information

• Verified date: June 2016
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Purpose: The purpose of the research is to learn more about how low blood sugar (low blood glucose or hypoglycemia) affects the way the blood vessels work in healthy people. Subjects who participate in this research project must be in good health and taking no medications.

Methods: A screening visit to the Clinical Research Center of the Ohio State University will be used to assess eligibility to participate. The main study consists of two visits to the Clinical Research Center that occur two to four weeks apart. Each of these visits will involve a procedure known as an insulin clamp. This involves giving insulin and sugar water into a vein. The amount of sugar given varies to keep the blood sugar at a predetermined level. For one of the two visits the blood sugar will be low and the other it will be normal. The function of the blood vessels will be measured three times during each study by measuring blood flow before and after stopping blood flow to the arm for 5 min.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age 18-40 years

• BMI <27 kg/m2

Exclusion Criteria:

• 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypoglycemia

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States,