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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Hoffman, Ohio State University
ClinicalTrials.gov Identifier:
NCT00373854
First received: September 7, 2006
Last updated: June 6, 2016
Last verified: June 2016
  Purpose

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.


Condition
Hypoglycemia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hypoglycemia and Endothelial Function

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Enrollment: 13
Study Start Date: September 2005
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy adults
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373854

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Study Chair: Robert P Hoffman, MD Ohio State University
  More Information

Responsible Party: Robert Hoffman, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00373854     History of Changes
Other Study ID Numbers: Endo 208 
Study First Received: September 7, 2006
Last Updated: June 6, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Observational study

Keywords provided by Ohio State University:
Hypoglycemia
Endothelial function

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 22, 2016