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

NCT ID: NCT00373854

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 13 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2006-09-30

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.

Detailed 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.

Conditions

Hypoglycemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Robert Hoffman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert P Hoffman, MD

Role: STUDY_CHAIR

Ohio State University

Locations

Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

Endo 208

Identifier Type: -

Identifier Source: org_study_id