HypoglycemiaNCT01283126
Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery
A study testing euglycemic and hypoglycemic clamp in people with Hypoglycemia, run by Joslin Diabetes Center at 1 site in United States.
Trial summary
The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy individuals and how well changes in (interstitial) tissue glucose levels correlate with changes in cognitive function as compared to blood glucose levels. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- euglycemic and hypoglycemic clamp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Oct 2015
- Phase
- Interventional
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- non obese (BMI <30), ages 18-50
Who cannot join
- renal or hepatic failure
- cancer or lymphoma
- malabsorption or malnourishment
- hypercortisolism
- alcoholism or drug abuse
- anemia
Show all 16Show fewer
- eating disorder or depression
- coronary artery disease
- Arrhythmias
- hypertension
- on medications known to affect the blood glucose to be measured such as
- glucocorticoids
- on blood thinning agents
- Pregnant women, breastfeeding women and women who want to become pregnant in the next 6 months will be excluded from the study.
- Subjects who have donated blood two weeks prior to the study.
- Allergies to pig derived products (Heparin will be used)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy individuals and how well changes in (interstitial) tissue glucose levels correlate with changes in cognitive function as compared to blood glucose levels.
Read the detailed description
Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured and cognitive function will be assessed.
- Conditions
- Hypoglycemia
- Being tested
- euglycemic and hypoglycemic clamp
- Keywords
- Hypoglycemia, cognitive function
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
euglycemic and hypoglycemic clampProcedure or surgery
Also called clamp
Subjects will undergo standard euglycemic and hypoglycemic clamps, and will have concurrent assessments of cognitive function and measurement of interstitial glucose concentrations.
| Study group | Role | What they receive |
|---|---|---|
| Euglycemic and hypoglycemic clamp | Experimental | Subjects will complete clamp study visit. Receives: Procedure: euglycemic and hypoglycemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive function correlation to blood or interstitial glucose
This investigator initiated study will evaluate cognitive function at the onset, during and following recovery from hypoglycemia and will determine if cognitive function correlates better with blood or interstitial glucose concentrations.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2014
- Study completionOct 2015
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joslin Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Diabetes Care
- Responsible party
- Sponsor
- Investigators
- Howard Wolpert, MD, Principal investigator, Joslin Diabetes CenterGreeshma K Shetty, MD, Study chair, Joslin Diabetes CenterGail Musen, PhD, Study chair, Joslin Diabetes CenterGail Adler, MD, PhD, Study chair, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283126
- Sponsor's protocol ID
- CHS #: 2010-09
- Status last verified
- May 2017
- First submitted
- 24 Jan 2011
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery
- ClinicalTrials.gov ID
- NCT01283126
- Acronym / sponsor ID
- CHS #: 2010-09
- Conditions
- Hypoglycemia
- Keywords
- Hypoglycemia, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Joslin Diabetes CenterUniversity, hospital or other
- Collaborators
- Abbott Diabetes Care
- Study start
- Jan 2011 (actual)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Jan 2011 (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.
The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy individuals and how well changes in (interstitial) tissue glucose levels correlate with changes in cognitive function as compared to blood glucose levels.
Detailed description
Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured and cognitive function will be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Euglycemic and hypoglycemic clamp | Experimental | Procedure: euglycemic and hypoglycemic clampSubjects will complete clamp study visit. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- non obese (BMI <30), ages 18-50
Key exclusion criteria (16 listed)
- renal or hepatic failure
- cancer or lymphoma
- malabsorption or malnourishment
- hypercortisolism
- alcoholism or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| euglycemic and hypoglycemic clampAlso: clampSubjects will undergo standard euglycemic and hypoglycemic clamps, and will have concurrent assessments of cognitive function and measurement of interstitial glucose concentrations. | Procedure or surgery | Euglycemic and hypoglycemic clamp |
Primary outcome
cognitive function correlation to blood or interstitial glucose
Time frame: 1 year
This investigator initiated study will evaluate cognitive function at the onset, during and following recovery from hypoglycemia and will determine if cognitive function correlates better with blood or interstitial glucose concentrations.
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 9 May 2017.
- Individual participant dataSharing planned: No
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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.
Howard Wolpert, MD principal investigator
Joslin Diabetes Center
Greeshma K Shetty, MD study chair
Joslin Diabetes Center
Gail Musen, PhD study chair
Joslin Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing euglycemic and hypoglycemic clamp in people with Hypoglycemia, run by Joslin Diabetes Center 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 1 inclusion and 16 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 9 May 2017. 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.
What does the primary outcome measure?
cognitive function correlation to blood or interstitial glucose (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 9 May 2017.