HypoglycemiaNCT00373854
Study of How Low Blood Sugar Affects the Way Blood Vessels Work
An observational study of Hypoglycemia, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults
Who may be able to join
- Age 18-40 years
- BMI <27 kg/m2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- Hypoglycemia, Endothelial function
- Medical subject headings
- Hypoglycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startSep 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Hoffman, Ohio State University
- Investigators
- Robert P Hoffman, MD, Study chair, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373854
- Sponsor's protocol ID
- Endo 208
- Status last verified
- Jun 2016
- First submitted
- 7 Sep 2006
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Observational study
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia and Endothelial Function
- ClinicalTrials.gov ID
- NCT00373854
- Acronym / sponsor ID
- Endo 208
- Conditions
- Hypoglycemia
- Keywords
- Hypoglycemia, Endothelial function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults
Key inclusion criteria (2 listed)
- Age 18-40 years
- BMI <27 kg/m2
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Individual participant dataSharing planned: No. Observational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert P Hoffman, MD study chair
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoglycemia, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.