Type 1 DiabetesPhase 2GlycogenNCT00786825
Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
A Phase 2 study testing somatostatin in people with Type 1 Diabetes, run by University of Minnesota at 1 site in United States.
Trial summary
The long-range goal of this project is to determine the effects of diabetes and the hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans. We will measure brain glycogen turnover and content in normal controls and subjects with diabetes under conditions of modest hyper-and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- somatostatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Dec 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Healthy control
- Must be able to provide informed consent
- Type 1 diabetes with hypoglycemia unawareness with hemoglobin A1c < 7.5%
- Poorly controlled diabetics with hemoglobin A1c > 7.5%
- Subjects with hypoglycemia unawareness must report an inability to recognize at least some blood glucose values <58 mg/dL during the 3 months prior to the study.
Who cannot join
- Over 300 pounds
- Claustrophobic
- History of ischemic heart disease, arrhythmia, of seizure disorder
- Pregnant
- On medications known to alter blood flow or carbohydrate metabolism
- Have internally located pieces of metal
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
The long-range goal of this project is to determine the effects of diabetes and the hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans. We will measure brain glycogen turnover and content in normal controls and subjects with diabetes under conditions of modest hyper-and hypoglycemia.
Read the detailed description
On the morning before the study subjects will report to the Clinical Research Center and will be asked to stay at the Clinical Research Center for up to 72 hours. You will be asked not to eat anything after midnight. Small plastic catheters will be placed in two veins in subjects arms for infusion of glucose and for measuring blood glucose levels every 15-30 minutes. While subjects are in the study they will continuously receive a small dose of glucose enriched with 13C label either through the catheter or by drinking a small amount of a sugar water solution every 15-60 minutes. Subjects will be asked to transfer to the Center for Magnetic Resonance Research every 6-8 hours (except at night) where they will be asked each time to conduct an MRI scan as follows: Subjects will be placed on the patient bed in the magnet room for one-to-two hours. A nurse will stay with the subject at all times during this study. During some of the scans subjects may be asked to perform a visual task such as watching a changing checkerboard pattern through a mirror placed in front of their eyes. After each scan subjects will receive a low carbohydrate meal for weight-maintenance.
Subjects may be asked to receive an infusion of glucose and/or insulin one-to-three times before and/or after the infusion of 13C-enriched glucose starts. During these infusions the subject's blood sugar will be maintained either higher or lower than normal levels for up to 3 hours. This will be done to assess the effect of hyper- or hypoglycemia on brain glycogen metabolism.
Subjects may also be asked several days prior to the study to report to the Clinical Research Center for a "mock" study to see if they are comfortable with the MRI scan and/or to test their body's response to either protocol (as described above, but carried out at the Clinical Research Center). If subjects would like to try the MRI procedure in advance, this test will not exceed 2 hours. If we need to test the subject's response to the infusion, this "pre-test" will involve only drawing blood and administering glucose and will be performed as described for either protocol above, but will last not more than 4 hours.
Magnetic resonance measurements will be performed in the magnet and are very similar to magnetic resonance imaging exams (MRI). Subjects will always have the possibility to signal when they feel claustrophobic and wish to be removed from the magnet. The magnetic resonance measurements will be associated with a regular clunking noise that subjects may initially find unpleasant. For their comfort they will be offered to wear ear plugs. During the measurements in the magnet subjects will be asked to lie still for most of the time.
- Conditions
- Type 1 Diabetes
- Being tested
- somatostatin
- Keywords
- Type 1 diabetes, Hypoglycemia unawareness
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatostatinDrug
Somatostatin may be used to suppress endogenous insulin secretion
| Study group | Role | What they receive |
|---|---|---|
| somatostatin | Experimental | Type 1 diabetes and Hypoglycemia unawareness Receives: Drug: somatostatin |
| 2 | No intervention | Healthy control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Glycogen Turnover Rate
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startDec 2004
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth R Seaquist, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786825
- Sponsor's protocol ID
- 9412M09040
- Acronym
- Glycogen
- Status last verified
- Dec 2019
- First submitted
- 5 Nov 2008
- Last updated
- 18 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Seaquist ER, Moheet A, Kumar A, Deelchand DK, Terpstra M, Kubisiak K, Eberly LE, Henry PG, Joers JM, Oz G. Hypothalamic Glucose Transport in Humans During Experimentally Induced Hypoglycemia-Associated Autonomic Failure. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3571-3580. doi: 10.1210/jc.2017-00477.
PubMed 28911152
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
- ClinicalTrials.gov ID
- NCT00786825
- Acronym / sponsor ID
- Glycogen / 9412M09040
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Hypoglycemia unawareness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2004 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-range goal of this project is to determine the effects of diabetes and the hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans. We will measure brain glycogen turnover and content in normal controls and subjects with diabetes under conditions of modest hyper-and hypoglycemia.
Detailed description
On the morning before the study subjects will report to the Clinical Research Center and will be asked to stay at the Clinical Research Center for up to 72 hours. You will be asked not to eat anything after midnight. Small plastic catheters will be placed in two veins in subjects arms for infusion of glucose and for measuring blood glucose levels every 15-30 minutes. While subjects are in the study they will continuously receive a small dose of glucose enriched with 13C label either through the catheter or by drinking a small amount of a sugar water solution every 15-60 minutes. Subjects will be asked to transfer to the Center for Magnetic Resonance Research every 6-8 hours (except at night) where they will be asked each time to conduct an MRI scan as follows: Subjects will be placed on the patient bed in the magnet room for one-to-two hours. A nurse will stay with the subject at all times during this study. During some of the scans subjects may be asked to perform a visual task such as watching a changing checkerboard pattern through a mirror placed in front of their eyes. After each scan subjects will receive a low carbohydrate meal for weight-maintenance.
Subjects may be asked to receive an infusion of glucose and/or insulin one-to-three times before and/or after the infusion of 13C-enriched glucose starts. During these infusions the subject's blood sugar will be maintained either higher or lower than normal levels for up to 3 hours. This will be done to assess the effect of hyper- or hypoglycemia on brain glycogen metabolism.
Subjects may also be asked several days prior to the study to report to the Clinical Research Center for a "mock" study to see if they are comfortable with the MRI scan and/or to test their body's response to either protocol (as described above, but carried out at the Clinical Research Center). If subjects would like to try the MRI procedure in advance, this test will not exceed 2 hours. If we need to test the subject's response to the infusion, this "pre-test" will involve only drawing blood and administering glucose and will be performed as described for either protocol above, but will last not more than 4 hours.
Magnetic resonance measurements will be performed in the magnet and are very similar to magnetic resonance imaging exams (MRI). Subjects will always have the possibility to signal when they feel claustrophobic and wish to be removed from the magnet. The magnetic resonance measurements will be associated with a regular clunking noise that subjects may initially find unpleasant. For their comfort they will be offered to wear ear plugs. During the measurements in the magnet subjects will be asked to lie still for most of the time.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| somatostatin | Experimental | Drug: somatostatinType 1 diabetes and Hypoglycemia unawareness |
| 2 | No intervention | –Healthy control subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65
- Healthy control
- Must be able to provide informed consent
- Type 1 diabetes with hypoglycemia unawareness with hemoglobin A1c < 7.5%
- Poorly controlled diabetics with hemoglobin A1c > 7.5%
Key exclusion criteria (6 listed)
- Over 300 pounds
- Claustrophobic
- History of ischemic heart disease, arrhythmia, of seizure disorder
- Pregnant
- On medications known to alter blood flow or carbohydrate metabolism
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 |
|---|---|---|
| somatostatinSomatostatin may be used to suppress endogenous insulin secretion | Drug | somatostatin |
Primary outcome
Brain Glycogen Turnover Rate
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28911152Seaquist ER, Moheet A, Kumar A, Deelchand DK, Terpstra M, Kubisiak K, Eberly LE, Henry PG, Joers JM, Oz G. Hypothalamic Glucose Transport in Humans During Experimentally Induced Hypoglycemia-Associated Autonomic Failure. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3571-3580. doi: 10.1210/jc.2017-00477.
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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.
Elizabeth R Seaquist, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing somatostatin in people with Type 1 Diabetes, run by University of Minnesota 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 6 inclusion and 6 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 18 Dec 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Brain Glycogen Turnover Rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786825, which also lists 1 linked publication.
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 18 Dec 2019.