Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Ohio State University
ClinicalTrials.gov Identifier:
NCT00373854
First received: September 7, 2006
Last updated: April 4, 2007
Last verified: April 2007
History of Changes

September 7, 2006
April 4, 2007
September 2005
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00373854 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of How Low Blood Sugar Affects the Way Blood Vessels Work
Hypoglycemia and Endothelial Function

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.

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.
Observational
Allocation: Random Sample
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
Hypoglycemia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2006
Not Provided

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373854
Endo 208
No
Not Provided
Ohio State University
Not Provided
Study Chair: Robert P Hoffman, MD Ohio State University
Ohio State University
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP