Type 1 DiabetesNCT00575783
Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM
An observational study of Type 1 Diabetes and Hypoglycemia, run by Yale University at 1 site in United States.
Trial summary
The research study is designed to examine the impact of low blood sugar on brain function in individuals with Type 1 Diabetes who have frequent and severe hypoglycemia (low blood sugar) compared to those who do not. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Aug 2008
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Group 1A) T1DM subjects with severe hypoglycemia unawareness and awaiting islet cell transplantation will be referred by participating islet transplantation centers. Group 1B) T1DM subjects with severe hypoglycemia unawareness but not awaiting islet cell transplantation will be from the greater New Haven, CT area. Group 2)T1DM, not optimally controlled and without hypoglycemia unawareness will be from the greater New Haven, CT area. Group 3) Non-Diabetics from the greater New Haven CT area.
Who may be able to join
- Age 18-49
- > 85 kg
- BMI <27female <28 male
- able to provide written informed consent
- able to speak and read English fluently
- must meet Magnetic Resonance safety evaluation
Show all 12Show fewer
- T1DM undergoing intensive clinical management and currently on the islet transplant list
- History of severe hypoglycemia
- T1DM undergoing intensive clinical management
- History of severe hypoglycemia unawareness
- T1DM with poor glycemic control, HbA1c > 8%
- no episodes of hypoglycemia requiring assistance from another person for at least 1 yr, no episodes in last 4 weeks, and hypoglycemia aware
Who cannot join
- Group 1A: (T1DM subjects being considered for islet cell transplantation)
- Detectable c-peptide level
- Untreated proliferative retinopathy
- Creatinine clearance < 65 ml/min/1.73 m2
- Serum creatinine ≥1.5 mg/dL
- Previous pancreas or islet transplant
Show all 51Show fewer
- Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
- Active infection including hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB ), or subjects with a positive PPD performed within 1 yr. of enrollment, and no history of adequate prophylaxis
- Invasive aspergillus infection within year prior to study entry
- Any history of malignancy except for adequately treated squamous or basal cell carcinoma of the skin
- Active alcohol or substance abuse- includes cigarette smoking (must be abstinent for 6 months)
- History of non-adherence to prescribed regimens
- Psychiatric disorder making the subject not a suitable candidate for transplantation
- Baseline Hgb < 10.5 g/dL in females, or < 13 g/dL in males; lymphopenia (<1,000/μL), or leukopenia (< 3,000 total leukocytes/μL), or an absolute CD4+ count < 500/μL
- History of coagulopathy or medical condition requiring long-term anticoagulant therapy (e.g., warfarin) after transplantation (low-dose aspirin treatment is allowed) or patient with INR >1.5
- Severe co-existing cardiac disease, as determined by referring center
- Baseline liver function tests outside of normal range (an initial liver function test panel with any values >1.5 times normal upper limits will exclude a patient without a re-test; a re-test for any values between normal and 1.5 times normal will be made, and if the values remain elevated above normal, the patient will be excluded), or history of significant liver disease
- Severe unremitting diarrhea or other gastrointestinal disorders potentially interfering with the ability to absorb oral medications
- Addison's disease as determined by clinical history
- Under treatment for a medical condition requiring chronic use of systemic steroids
- Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
- Group 1 B: (T1DM with Severe Hypoglycemia Unawareness not on the Transplant List)
- Detectable C-peptide level
- Serum creatinine ≥1.5 mg/dL
- Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
- Active alcohol or substance abuse- includes cigarette smoking (must be abstinent for 6 months)
- Psychiatric disorder making the subject not a suitable candidate for transplantation
- Baseline Hgb < 10.5 g/dL in females, or < 13 g/dL in males
- Baseline liver function tests outside of normal range (an initial liver function test panel with any values >1.5 times normal upper limits will exclude a patient without a re-test; a re-test for any values between normal and 1.5 times normal will be made, and if the values remain elevated above normal, the patient will be excluded), or history of significant liver disease
- Under treatment for a medical condition requiring chronic use of systemic steroids
- Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
- Group 2: (T1DM control subjects)
- Detectable C-peptide level
- Serum creatinine ≥1.5 mg/dL
- Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
- Any history of malignancy except for adequately treated squamous or basal cell carcinoma of the skin
- Active alcohol or substance abuse- includes cigarette smoking (must be abstinent for 6 months)
- Baseline Hgb < 10.5 g/dL in females, or < 13 g/dL in males Baseline liver function tests outside of normal range (an initial liver function test panel with any values >1.5 times normal upper limits will exclude a patient without a re-test; a re-test for any values between normal and 1.5 times normal will be made, and if the values remain elevated above normal, the patient will be excluded), or history of significant liver disease
- Addison's disease as determined by clinical history
- Under treatment for a medical condition requiring chronic use of systemic steroids
- Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
- Group 3: (Normal Controls)
- FBG > 100 mg/dL
- Serum creatinine ≥1.5 mg/dL
- Positive pregnancy test, or presently breast-feeding, or failure to follow effective contraceptive measures
- Any history of malignancy except for adequately treated squamous or basal cell carcinoma of the skin
- Active alcohol or substance abuse- includes cigarette smoking (must be abstinent for 6 months)
- Baseline Hgb < 10.5 g/dL in females, or < 13 g/dL in males
- Baseline liver function tests outside of normal range (an initial liver function test panel with any values >1.5 times normal upper limits will exclude a patient without a re-test; a re-test for any values between normal and 1.5 times normal will be made, and if the values remain elevated above normal, the patient will be excluded), or history of significant liver disease
- Under treatment for a medical condition requiring chronic use of systemic steroids
- Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
The research study is designed to examine the impact of low blood sugar on brain function in individuals with Type 1 Diabetes who have frequent and severe hypoglycemia (low blood sugar) compared to those who do not.
Read the detailed description
During the course of treating diabetes (for example, after an insulin injection), blood sugar levels will sometimes drop too low. This condition is known as hypoglycemia. Normally, a healthy body responds to hypoglycemia by producing a number of "anti-insulin" hormones which raise blood sugar levels. In addition, these hormones provide the individual with warning signals of hypoglycemia, including hunger, sweating, shaking and heart palpitations. These warning signals allow diabetics to correct low blood sugar levels by eating sugar tablets or by having a snack.
Unfortunately, and for unclear reasons, many people with longstanding diabetes lose their ability to recognize low blood sugar levels-a condition called "hypoglycemia unawareness." The brain, in particular, is extremely sensitive to hypoglycemia. Unable to sense and respond to low blood sugar levels, these individuals may experience a sudden onset of blurred vision, confusion, seizures, coma, or even death.
In recent years, a new technique called "islet cell transplantation" has been developed as an alternate means of treating insulin-dependent diabetes. Pancreatic islet cells (the cells that produce insulin), from human donors, are injected into the diabetic patient's liver where the cells are capable of making insulin and can regulate blood sugar levels without the need for insulin injections. Currently, this technique is used primarily in patients with severe hypoglycemia unawareness.
While it is known that islet cell transplantation can reduce the risk of severe hypoglycemia, the effects of transplantation on hypoglycemia unawareness are unknown. This study is designed to investigate why hypoglycemia unawareness happens and the impact it has on brain function in individuals with type 1 diabetes.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- type 1 diabetes, hypoglycemia, magnetic resonance imaging
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1A, 1B | Type 1 diabetic subjects with a history of severe hypoglycemia and hypoglycemia unawareness who: 1A) meet criteria for islet cell transplantation and are referred by a participating islet cell transplantation center 1B) meet similar criteria but are not currently planning islet cell transplantation | |
| 2 | Type 1 diabetics who are not optimally controlled (>8% HbA1c) and rarely experience hypoglycemia | |
| 3 | Healthy non-diabetics |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2007 (estimated)
- Study startAug 2005
- Study completionAug 2008
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.
- More trials run by Yale 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
- Cross-sectional
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Miami, University of Minnesota
- Responsible party
- Sponsor
- Investigators
- Robert Sherwin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00575783
- Sponsor's protocol ID
- 0505000077_B
- Other IDs
- R01DK072409, HIC# 0505000077
- Status last verified
- Mar 2020
- First submitted
- 14 Dec 2007
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM
- ClinicalTrials.gov ID
- NCT00575783
- Acronym / sponsor ID
- 0505000077_B
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- type 1 diabetes, hypoglycemia, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Miami, University of Minnesota
- Study start
- Aug 2005
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Dec 2007 (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 research study is designed to examine the impact of low blood sugar on brain function in individuals with Type 1 Diabetes who have frequent and severe hypoglycemia (low blood sugar) compared to those who do not.
Detailed description
During the course of treating diabetes (for example, after an insulin injection), blood sugar levels will sometimes drop too low. This condition is known as hypoglycemia. Normally, a healthy body responds to hypoglycemia by producing a number of "anti-insulin" hormones which raise blood sugar levels. In addition, these hormones provide the individual with warning signals of hypoglycemia, including hunger, sweating, shaking and heart palpitations. These warning signals allow diabetics to correct low blood sugar levels by eating sugar tablets or by having a snack.
Unfortunately, and for unclear reasons, many people with longstanding diabetes lose their ability to recognize low blood sugar levels-a condition called "hypoglycemia unawareness." The brain, in particular, is extremely sensitive to hypoglycemia. Unable to sense and respond to low blood sugar levels, these individuals may experience a sudden onset of blurred vision, confusion, seizures, coma, or even death.
In recent years, a new technique called "islet cell transplantation" has been developed as an alternate means of treating insulin-dependent diabetes. Pancreatic islet cells (the cells that produce insulin), from human donors, are injected into the diabetic patient's liver where the cells are capable of making insulin and can regulate blood sugar levels without the need for insulin injections. Currently, this technique is used primarily in patients with severe hypoglycemia unawareness.
While it is known that islet cell transplantation can reduce the risk of severe hypoglycemia, the effects of transplantation on hypoglycemia unawareness are unknown. This study is designed to investigate why hypoglycemia unawareness happens and the impact it has on brain function in individuals with type 1 diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1A, 1B | – | –Type 1 diabetic subjects with a history of severe hypoglycemia and hypoglycemia unawareness who: 1A) meet criteria for islet cell transplantation and are referred by a participating islet cell transplantation center 1B) meet similar criteria but are not currently planning islet cell transplantation |
| 2 | – | –Type 1 diabetics who are not optimally controlled (>8% HbA1c) and rarely experience hypoglycemia |
| 3 | – | –Healthy non-diabetics |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Group 1A) T1DM subjects with severe hypoglycemia unawareness and awaiting islet cell transplantation will be referred by participating islet transplantation centers. Group 1B) T1DM subjects with severe hypoglycemia unawareness but not awaiting islet cell transplantation will be from the greater New Haven, CT area. Group 2)T1DM, not optimally controlled and without hypoglycemia unawareness will be from the greater New Haven, CT area. Group 3) Non-Diabetics from the greater New Haven CT area.
Key inclusion criteria (12 listed)
- T1DM undergoing intensive clinical management and currently on the islet transplant list
- History of severe hypoglycemia
- T1DM undergoing intensive clinical management
- History of severe hypoglycemia unawareness
- T1DM with poor glycemic control, HbA1c > 8%
Key exclusion criteria (51 listed)
- Group 1A: (T1DM subjects being considered for islet cell transplantation)
- Detectable c-peptide level
- Untreated proliferative retinopathy
- Creatinine clearance < 65 ml/min/1.73 m2
- Serum creatinine ≥1.5 mg/dL
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 2 Apr 2020.
- American Diabetes AssociationLink provided by the sponsor.
- Juvenile Diabetes Research FoundationLink provided by the sponsor.
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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 Sherwin, MD principal investigator
Yale 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 Type 1 Diabetes and Hypoglycemia, run by Yale 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 12 inclusion and 51 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 2 Apr 2020. 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 2 Apr 2020.