Type 1 DiabetesNCT00600730
The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia
A study testing Hyperinsulinemic euglycemic clamp with fMRi and Hyperinsulinemic hypoglycemic clamp study with fMRi in people with Type 1 Diabetes, run by Vanderbilt University.
Trial summary
The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Hyperinsulinemic euglycemic clamp with fMRi and Hyperinsulinemic hypoglycemic clamp study with fMRi
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged 18-45
- Type 1 diabetes mellitus patients aged 18-45
- Body Mass Index 21-38 kg/m2
- Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities and an EKG stress test.
- Female volunteers of childbearing potential will undergo HCG pregnancy test. Only women who are not pregnant will participate in the study.
- Diabetic Subjects:
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- HBA1C= 5.5-11.0%
- Duration of Type 1 Diabetes > 3 yr
- Normal bedside autonomic function
Who cannot join
- All Subjects
- Prior or current history of poor health
- Abnormal results following screening tests
- Pregnancy
- Subjects unable to give voluntary informed consent
- Subjects with a recent medical illness
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- Subjects with a history of hypertension, heart disease or cerebrovascular disease
- Subjects with known liver or kidney disease
- Subjects with recent weight loss or consuming a low carbohydrate diet
- Subjects taking steroids
- Subjects taking beta-blockers
- Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
- Evidence of diabetic neuropathy, autonomic neuropathy, proteinuria, extensive background or proliferative retinopathy, hypertension, or cardiovascular disease
About this study
The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.
Read the detailed description
The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.
During the past decade many studies have shown that appropriate magnetic resonance imaging (MRI) methods may be used to assess alterations in brain regional activation in response to external stimuli or tasks. Thus, this non-invasive technique will enhance our ability to learn more about brain function, during hypoglycemia and may delineate information about the role of the brain in hypoglycemia associated autonomic dysfunction.
- Conditions
- Type 1 Diabetes
- Being tested
- Hyperinsulinemic euglycemic clamp with fMRi, Hyperinsulinemic hypoglycemic clamp study with fMRi
- Keywords
- fMRi, hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic euglycemic clamp with fMRiProcedure or surgery
Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi
Hyperinsulinemic hypoglycemic clamp study with fMRiProcedure or surgery
Hyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Hyperinsulinemic euglycemic clamp with fMRi Receives: Procedure: Hyperinsulinemic euglycemic clamp with fMRi |
| 2 | Experimental | Hyperinsulinemic hypoglycemic clamp with fMRI Receives: Procedure: Hyperinsulinemic hypoglycemic clamp study with fMRi |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRi scans
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
Why it stopped: Funding not available. Could not start this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Steve Davis, Vanderbilt University
- Investigators
- Stephen N Davis, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600730
- Sponsor's protocol ID
- IRB#040025-Brain and Hypo
- Other IDs
- R01DK069803-03
- Status last verified
- Jun 2015
- First submitted
- 14 Jan 2008
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia
- ClinicalTrials.gov ID
- NCT00600730
- Acronym / sponsor ID
- IRB#040025-Brain and Hypo
- Conditions
- Type 1 Diabetes
- Keywords
- fMRi, hypoglycemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not available. Could not start this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- First posted
- 25 Jan 2008 (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 studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.
Detailed description
The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.
During the past decade many studies have shown that appropriate magnetic resonance imaging (MRI) methods may be used to assess alterations in brain regional activation in response to external stimuli or tasks. Thus, this non-invasive technique will enhance our ability to learn more about brain function, during hypoglycemia and may delineate information about the role of the brain in hypoglycemia associated autonomic dysfunction.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Hyperinsulinemic euglycemic clamp with fMRiHyperinsulinemic euglycemic clamp with fMRi |
| 2 | Experimental | Procedure: Hyperinsulinemic hypoglycemic clamp study with fMRiHyperinsulinemic hypoglycemic clamp with fMRI |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male and female subjects aged 18-45
- Type 1 diabetes mellitus patients aged 18-45
- Body Mass Index 21-38 kg/m2
- Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities and an EKG stress test.
- Female volunteers of childbearing potential will undergo HCG pregnancy test. Only women who are not pregnant will participate in the study.
Key exclusion criteria (13 listed)
- All Subjects
- Prior or current history of poor health
- Abnormal results following screening tests
- Pregnancy
- Subjects unable to give voluntary informed consent
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 |
|---|---|---|
| Hyperinsulinemic euglycemic clamp with fMRiHyperinsulinemic euglycemic clamp on day 1 with morning fMRi | Procedure or surgery | 1 |
| Hyperinsulinemic hypoglycemic clamp study with fMRiHyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning | Procedure or surgery | 2 |
Primary outcome
fMRi scans
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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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.
Stephen N Davis, MD principal investigator
Vanderbilt University
Questions about this trial
What is this clinical trial studying?
A study testing Hyperinsulinemic euglycemic clamp with fMRi and Hyperinsulinemic hypoglycemic clamp study with fMRi in people with Type 1 Diabetes, run by Vanderbilt University.
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 9 inclusion and 13 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: withdrawn, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
fMRi scans (time frame: 1 day). 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 10 Jun 2015.