Type 1 DiabetesPhase 1/2NaltrexoneNCT01053078
Naltrexone and Hypoglycemia in Type 1 Diabetes
A Phase 1/2 study testing Naltrexone in people with Type 1 Diabetes and Hypoglycemia Unawareness, run by University of Minnesota at 1 site in United States.
Trial summary
Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. 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, Hypoglycemia Unawareness
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2014
- Phase
- Phase 1/2
- 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
- 18-65 years of age
- Type 1 diabetes
- Hypoglycemia unawareness
- Capable of providing informed consent
Who cannot join
- Concomitant regular use of acetaminophen, aspirin or ibuprofen
- History of drug or alcohol abuse
- Psychiatric illness
- Elevations in ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), creatinine or history of hepatitis, liver failure, or renal failure/insufficiency
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Study of the Effect of Naltrexone on Cerebral Blood Flow and Hypoglycemia in Type 1 Diabetes Mellitus
Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizures, coma, and even death.
Some people with diabetes do not have early warning signs of low blood sugar. This condition is called hypoglycemia unawareness. It happens when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia. This can lead to more severe and dangerous hypoglycemia.
The purpose of this early study is to see if a drug called naltrexone should be studied more in people with Type I diabetes and hypoglycemia unawareness. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.
Read the detailed description
Visit 1
This visit is estimated to last approximately 1 hour.
At this visit, you will be asked to complete a questionnaire about hypoglycemia unawareness. Some questions about your medical history may be asked in order to make sure you are eligible to be in this study. You will also have some blood collected for tests that measure how your liver and kidneys are working. A blood test that measures muscle breakdown will also be done. If you are a female who could become pregnant, a pregnancy test will also be done. The amount of blood that will be collected at this visit is approximately three teaspoons. This visit is estimated to last approximately one hour.
You will be asked to wear a continuous glucose monitor (CGMS) around the clock for the seven days before the MRI study. This involves putting a small plastic sensor under the skin on your stomach and carrying the monitor that attaches to the sensor. The sensor measures your glucose and records the readings automatically on the monitor. The monitor is about the size of the palm of a woman's hand. The information stored on the monitor can be sent to a computer that the researcher uses. The researcher will insert the CGMS at visit 1.
Between Visit 1 and Visit 2
You will also be asked to keep careful records for the study every day for the next seven days. You will be asked to check your blood glucose before each of three meals and before you go to sleep at night. You will also be asked to write down your blood glucose levels and bring those records back for the researcher.
Visit 2
Seven days after visit 1 you will be asked to report to the Center for Magnetic Resonance Research (CMRR) at 7:30AM for your first MRI scan. The study will be done in the morning after an overnight fast. All subjects will be asked to fast for a minimum of 8 hours before arriving at the center. The researcher will advise you on how to adjust your insulin regimen during the 1-2 days before the MRI scan to be sure your blood sugar is in good control when you arrive at the CMRR.
Alternatively, you may be asked to come to the Clinical Research Unit the night before the MRI study You will be admitted to the Clinical Research Unit, and stay overnight there. You will not be given any food after your evening meal until your test is completed at about lunch time on the following day. Your evening dose of long-acting insulin or your pump will be held after 6:00 p.m. that evening. Your blood glucose will be measured every 1-2 hours. An intravenous (IV) catheter will be placed in your arm and will stay there until your test is over the next day. You will be given insulin and glucose as needed to keep your blood sugars between 100 and 150 mg/dl through the night leading to testing on the next day. In the morning, you will be transferred to the Center for Magnetic Resonance Research (CMRR) for an MRI.
At the CMRR, an IV will be placed in each of your arms. This will allow for giving insulin, glucose and potassium during the test. A third IV will be placed in one of your legs. This catheter will be put in so that blood can be collected during the test. After the catheter in your leg is placed you will rest for 30 minutes. After thirty minutes, blood will be collected from the catheter in your leg for laboratory tests. The test is then ready to begin.
You will be given insulin through the catheter in one arm and you will be placed in the MRI machine. Your glucose will be checked every five minutes throughout the study. Blood will also be collected every 30 minutes for other laboratory tests. When your glucose drops to 50 mg/dl it will be held at that level for approximately 30 minutes so the measures of blood flow and glucose concentrations in your brain can be taken. While your blood sugar is dropping, you will be asked about any symptoms you may feel. After the measures have been taken, the insulin given through the IV will be stopped and you will be given glucose to bring it back to a normal level.
You will be at the CMRR for 4-6 hours. After the test is completed, your IVs will be taken out, you will resume your usual diabetes treatments, and you will be fed a meal.
Between the time you are admitted to the Clinical Research Unit and the time you are discharged after your MRI test, just less than one cup of blood will be collected.
You will be given a supply of naltrexone, the study medication, or placebo, with instructions for taking the medication over the next four weeks. You will be randomly assigned (like a flip of a coin) to naltrexone, or to a placebo (a pill that does not contain any medicine). Neither you nor your study doctor will know which study treatment (placebo or naltrexone) you are receiving. If it becomes necessary to know for medical reasons, the information will be made available.
Between Visits 2 and 3
While you are taking naltrexone or placebo you will be asked not to use Tylenol (or any other product containing acetaminophen), Advil (or any other product containing ibuprofen or a non-steroidal anti-inflammatory drug), or aspirin. You will also be asked to avoid alcohol while taking naltrexone. If you have any concerns or questions about using these substances during the time you are taking naltrexone please ask the study doctor or coordinator.
You should always take your naltrexone dose right after you eat a meal.
Days 1 - 5: Starting the day after your MRI test, you will be asked to take one 25 mg tablet of naltrexone or placebo each day for the next five days.
Days 6 - 10: On these days you will be asked to take one 50 mg tablet of naltrexone or placebo each day.
Days 11- 14: On these days you will be asked to take one 50 mg tablet of naltrexone or placebo twice each day. Visit 2 for the study will occur on Day 14.
Visit 3
This visit is estimated to last approximately 30 minutes.
You will come to the Clinical Research Unit for a short visit on this day. Blood will be collected for tests that measure how your liver and kidneys are working. A blood test that measures muscle breakdown will also be done. Just like at visit 1, the amount of blood collected from you at this visit will be approximately three teaspoons.
The study doctor or coordinator will also talk to you about how you are feeling. You will be asked about whether you have been taking naltrexone or placebo according to the study plan.
Between Visits 3 and 4
Days 15 - 21: On these days you will be asked to take one 50 mg tablet of naltrexone or placebo twice each day.
Visit 4
This visit is estimated to last approximately 30 minutes.
You will be asked to wear a continuous glucose monitor (CGMS) around the clock for the seven days before the MRI study. This involves putting a small plastic sensor under the skin on your stomach and carrying the monitor that attaches to the sensor. The sensor measures your glucose and records the readings automatically on the monitor. The monitor is about the size of the palm of a woman's hand. The information stored on the monitor can be sent to a computer that the researcher uses. The researcher will insert the CGMS at visit 4.
Between Visits 4 and 5
Days 22 - 28: On these days you will be asked to take one 50 mg tablet of naltrexone or placebo twice each day. You will take your last study dose of naltrexone or placebo on Day 28.
Starting on Day 22, just like in the first part of this study, you will also be asked to keep careful records for the study every day during this time. You will be asked to check your blood glucose before each of three meals and before you go to sleep at night. You will also be asked to write down your blood glucose levels and bring those records back for the researcher.
Visit 5
Just like in the first part of the study, you will be asked to report to the Center for Magnetic Resonance Research (CMRR) at 7:30AM for your first MRI scan. The study will be done in the morning after an overnight fast. All subjects will be asked to fast for a minimum of 8 hours before arriving at the center. The researcher will advise you on how to adjust your insulin regimen during the 1-2 days before the MRI scan to be sure your blood sugar is in good control when you arrive at the CMRR.
Alternatively, you will be asked to come to the Clinical Research Unit the night before the MRI study. You will come in the day before you take your last dose of naltrexone or placebo. You will be admitted to the Clinical Research Unit, and stay overnight there. You will not be given any food after your evening meal until your test is completed at about lunch time on the following day. Your evening dose of long-acting insulin or your pump will be held after 6:00 p.m. that evening. Your blood glucose will be measured every 1-2 hours. An intravenous (IV) catheter will be placed in your arm and will stay there until your test is over the next day. You will be given insulin and glucose as needed to keep your blood sugars between 100 and 150 mg/dl through the night leading to testing on the next day. In the morning, you will be transferred to the Center for Magnetic Resonance Research (CMRR) for an MRI.
Blood will be collected for tests that measure how your liver and kidneys are working. A blood test that measures muscle breakdown will also be done.
The procedures for Visit 5 will be exactly the same as the procedures in Visit 2. The only difference is that you will not be given any naltrexone or placebo at the end of the visit. When you complete Visit 5, your participation in the study has been completed.
At the CMRR, an IV will be placed in each of your arms. This will allow for giving insulin, glucose and potassium during the test. A third IV will be placed in one of your legs. This catheter will be put in so that blood can be collected during the test. After the catheter in your leg is placed you will rest for 30 minutes. After thirty minutes, blood will be collected from the catheter in your leg for laboratory tests. The test is then ready to begin.
You will be given insulin through the catheter in one arm and you will be placed in the MRI machine. Your glucose will be checked every five minutes throughout the study. Blood will also be collected every 30 minutes for other laboratory tests. When your glucose drops to 50 mg/dl it will be held at that level for approximately 30 minutes so the measures of blood flow and glucose concentrations in your brain can be taken. While your blood sugar is dropping, you will be asked about any symptoms you may feel. After the measures have been taken, the insulin given through the IV will be stopped and you will be given glucose to bring it back to a normal level.
You will be at the CMRR for 4-6 hours. After the test is completed, your IVs will be taken out, you will resume your usual diabetes treatments, and you will be fed a meal.
Between the time you are admitted to the Clinical Research Unit and the time you are discharged after your MRI test, just less than one cup of blood will be collected.
- Conditions
- Type 1 Diabetes, Hypoglycemia Unawareness
- Being tested
- Naltrexone, Placebo
- Keywords
- Type 1 diabetes, Hypoglycemia unawareness, low blood sugar
- 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.
NaltrexoneDrug
Also called ReVia
1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days
PlaceboOther
1 month treatment; placebo tablet once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | Not described Receives: Drug: Naltrexone |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow
Measured: 1 month
Secondary outcomes (1)
Hypoglycemia Symptom Score
Hypoglycemia symptom score is determined by a standardized 12-item questionnaire. Participants rank hypoglycemic symptoms on a Likert scale from 0 (no symptoms) to 6 (severe symptoms). Total score is a sum of the 12 items scores with a total score range from 0 to 72. Higher scores indicated increased severity of symptoms associated with hypoglycemia.
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 posted21 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionJun 2014
- Study completionJun 2014
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 (2)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Elizabeth R Seaquist, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053078
- Sponsor's protocol ID
- 0903M60907
- Other IDs
- R01DK062440, 7-09-DCS-02
- Acronym
- Naltrexone
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2010
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Olawsky E, Zhang Y, Eberly LE, Helgeson ES, Chow LS. A New Analysis Tool for Continuous Glucose Monitor Data. J Diabetes Sci Technol. 2022 Nov;16(6):1496-1504. doi: 10.1177/19322968211028909. Epub 2021 Jul 20.
PubMed 34282646Moheet A, Mangia S, Kumar A, Tesfaye N, Eberly LE, Bai Y, Kubisiak K, Seaquist ER. Naltrexone for treatment of impaired awareness of hypoglycemia in type 1 diabetes: A randomized clinical trial. J Diabetes Complications. 2015 Nov-Dec;29(8):1277-82. doi: 10.1016/j.jdiacomp.2015.08.004. Epub 2015 Aug 12.
PubMed 26345338
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Naltrexone on Cerebral Blood Flow and Hypoglycemia in Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01053078
- Acronym / sponsor ID
- Naltrexone / 0903M60907
- Conditions
- Type 1 Diabetes, Hypoglycemia Unawareness
- Keywords
- Type 1 diabetes, Hypoglycemia unawareness, low blood sugar
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), American Diabetes Association
- Study start
- Oct 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Jan 2010 (estimated)
- Results
- Posted 12 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizures, coma, and even death.
Some people with diabetes do not have early warning signs of low blood sugar. This condition is called hypoglycemia unawareness. It happens when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia. This can lead to more severe and dangerous hypoglycemia.
The purpose of this early study is to see if a drug called naltrexone should be studied more in people with Type I diabetes and hypoglycemia unawareness. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.
Detailed description
Visit 1
This visit is estimated to last approximately 1 hour.
At this visit, you will be asked to complete a questionnaire about hypoglycemia unawareness. Some questions about your medical history may be asked in order to make sure you are eligible to be in this study. You will also have some blood collected for tests that measure how your liver and kidneys are working. A blood test that measures muscle breakdown will also be done. If you are a female who could become pregnant, a pregnancy test will also be done. The amount of blood that will be collected at this visit is approximately three teaspoons. This visit is estimated to last approximately one hour.
You will be asked to wear a continuous glucose monitor (CGMS) around the clock for the seven days before the MRI study. This involves putting a small plastic sensor under the skin on your stomach and carrying the monitor that attaches to the sensor. The sensor measures your glucose and records the readings automatically on the monitor. The monitor is about the size of the palm of a woman's hand. The information stored on the monitor can be sent to a computer that the researcher uses. The researcher will insert the CGMS at visit 1.
Between Visit 1 and Visit 2
You will also be asked to keep careful records for the study every day for the next seven days. You will be asked to check your blood glucose before each of three meals and before you go to sleep at night. You will also be asked to write down your blood glucose levels and bring those records back for the researcher.
Visit 2
Seven days after visit 1 you will be asked to report to the Center for Magnetic Resonance Research (CMRR) at 7:30AM for your first MRI scan. The study will be done in the morning after an overnight fast. All subjects will be asked to fast for a minimum of 8 hours before arriving at the center. The researcher will advise you on how to adjust your insulin regimen during the 1-2 days before the MRI scan to be sure your blood sugar is in good control when you arrive at the CMRR.
Alternatively, you may be asked to come to the Clinical Research Unit the night before the MRI study You will be admitted to the Clinical Research Unit, and stay overnight there. You will not be given any food after your evening meal until your test is completed at about lunch time on the following day. Your evening dose of long-acting insulin or your pump will be held after 6:00 p.m. that evening. Your blood glucose will be measured every 1-2 hours. An intravenous (IV) catheter will be placed in your arm and will stay there until your test is over the next day. You will be given insulin and glucose as needed to keep your blood sugars between 100 and 150 mg/dl through the night leading to testing on the next day. In the morning, you will be transferred to the Center for Magnetic Resonance Research (CMRR) for an MRI.
At the CMRR, an IV will be placed in each of your arms. This will allow for giving insulin, glucose and potassium during the test. A third IV will be placed in one of your legs. This catheter will be put in so that blood can be collected during the test. After the catheter in your leg is placed you will rest for 30 minutes. After thirty minutes, blood will be collected from the catheter in your leg for laboratory tests. The test is then ready to begin.
You will be given insulin through the catheter in one arm and you will be placed in the MRI machine. Your glucose will be checked every five minutes throughout the study. Blood will also be collected every 30 minutes for other laboratory tests. When your glucose drops to 50 mg/dl it will be held at that level for approximately 30 minutes so the measures of blood flow and glucose concentrations in your brain can be taken. While your blood sugar is dropping, you will be asked about any symptoms you may feel. After the measures have been taken, the insulin given through the IV will be stopped and you will be given glucose to bring it back to a normal level.
You will be at the CMRR for 4-6 hours. After the test is completed, your IVs will be taken out, you will resume your usual diabetes treatments, and you will be fed a meal.
Between the time you are admitted to the Clinical Research Unit and the time you are discharged after your MRI test, just less than one cup of blood will be collected.
You will be given a supply of naltrexone, the study medication, or placebo, with instructions for taking the medication over the next four weeks. You will be randomly assigned (like a flip of a coin) to naltrexone, or to a placebo (a pill that does not contain any medicine). Neither you nor your study doctor will know which study treatment (placebo or naltrexone) you are receiving. If it becomes necessary to know for medical reasons, the information will be made available.
Between Visits 2 and 3
While you are taking naltrexone or placebo you will be asked not to use Tylenol (or any other product containing acetaminophen), Advil (or any other product containing ibuprofen or a non-steroidal anti-inflammatory drug), or aspirin. You will also be asked to avoid alcohol while taking naltrexone. If you have any concerns or questions about using these substances during the time you are taking naltrexone please ask the study doctor or coordinator.
You should always take your naltrexone dose right after you eat a meal.
Days 1 - 5: Starting the day after your MRI test, you will be asked to take one 25 mg tablet of naltrexone or placebo each day for the next five days.
Days 6 - 10: On these days you will be asked to take one 50 mg tablet of naltrexone or placebo each day.
Days 11- 14: On these days you will be asked to take one 50 mg tablet of naltrexone or placebo twice each day. Visit 2 for the study will occur on Day 14.
Visit 3
This visit is estimated to last approximately 30 minutes.
You will come to the Clinical Research Unit for a short visit on this day. Blood will be collected for tests that measure how your liver and kidneys are working. A blood test that measures muscle breakdown will also be done. Just like at visit 1, the amount of blood collected from you at this visit will be approximately three teaspoons.
The study doctor or coordinator will also talk to you about how you are feeling. You will be asked about whether you have been taking naltrexone or placebo according to the study plan.
Between Visits 3 and 4
Days 15 - 21: On these days you will be asked to take one 50 mg tablet of naltrexone or placebo twice each day.
Visit 4
This visit is estimated to last approximately 30 minutes.
You will be asked to wear a continuous glucose monitor (CGMS) around the clock for the seven days before the MRI study. This involves putting a small plastic sensor under the skin on your stomach and carrying the monitor that attaches to the sensor. The sensor measures your glucose and records the readings automatically on the monitor. The monitor is about the size of the palm of a woman's hand. The information stored on the monitor can be sent to a computer that the researcher uses. The researcher will insert the CGMS at visit 4.
Between Visits 4 and 5
Days 22 - 28: On these days you will be asked to take one 50 mg tablet of naltrexone or placebo twice each day. You will take your last study dose of naltrexone or placebo on Day 28.
Starting on Day 22, just like in the first part of this study, you will also be asked to keep careful records for the study every day during this time. You will be asked to check your blood glucose before each of three meals and before you go to sleep at night. You will also be asked to write down your blood glucose levels and bring those records back for the researcher.
Visit 5
Just like in the first part of the study, you will be asked to report to the Center for Magnetic Resonance Research (CMRR) at 7:30AM for your first MRI scan. The study will be done in the morning after an overnight fast. All subjects will be asked to fast for a minimum of 8 hours before arriving at the center. The researcher will advise you on how to adjust your insulin regimen during the 1-2 days before the MRI scan to be sure your blood sugar is in good control when you arrive at the CMRR.
Alternatively, you will be asked to come to the Clinical Research Unit the night before the MRI study. You will come in the day before you take your last dose of naltrexone or placebo. You will be admitted to the Clinical Research Unit, and stay overnight there. You will not be given any food after your evening meal until your test is completed at about lunch time on the following day. Your evening dose of long-acting insulin or your pump will be held after 6:00 p.m. that evening. Your blood glucose will be measured every 1-2 hours. An intravenous (IV) catheter will be placed in your arm and will stay there until your test is over the next day. You will be given insulin and glucose as needed to keep your blood sugars between 100 and 150 mg/dl through the night leading to testing on the next day. In the morning, you will be transferred to the Center for Magnetic Resonance Research (CMRR) for an MRI.
Blood will be collected for tests that measure how your liver and kidneys are working. A blood test that measures muscle breakdown will also be done.
The procedures for Visit 5 will be exactly the same as the procedures in Visit 2. The only difference is that you will not be given any naltrexone or placebo at the end of the visit. When you complete Visit 5, your participation in the study has been completed.
At the CMRR, an IV will be placed in each of your arms. This will allow for giving insulin, glucose and potassium during the test. A third IV will be placed in one of your legs. This catheter will be put in so that blood can be collected during the test. After the catheter in your leg is placed you will rest for 30 minutes. After thirty minutes, blood will be collected from the catheter in your leg for laboratory tests. The test is then ready to begin.
You will be given insulin through the catheter in one arm and you will be placed in the MRI machine. Your glucose will be checked every five minutes throughout the study. Blood will also be collected every 30 minutes for other laboratory tests. When your glucose drops to 50 mg/dl it will be held at that level for approximately 30 minutes so the measures of blood flow and glucose concentrations in your brain can be taken. While your blood sugar is dropping, you will be asked about any symptoms you may feel. After the measures have been taken, the insulin given through the IV will be stopped and you will be given glucose to bring it back to a normal level.
You will be at the CMRR for 4-6 hours. After the test is completed, your IVs will be taken out, you will resume your usual diabetes treatments, and you will be fed a meal.
Between the time you are admitted to the Clinical Research Unit and the time you are discharged after your MRI test, just less than one cup of blood will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: Naltrexone |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age
- Type 1 diabetes
- Hypoglycemia unawareness
- Capable of providing informed consent
Key exclusion criteria (5 listed)
- Concomitant regular use of acetaminophen, aspirin or ibuprofen
- History of drug or alcohol abuse
- Psychiatric illness
- Elevations in ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase), creatinine or history of hepatitis, liver failure, or renal failure/insufficiency
- Pregnant or breastfeeding
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 |
|---|---|---|
| NaltrexoneAlso: ReVia1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days | Drug | Naltrexone |
| Placebo1 month treatment; placebo tablet once daily for 28 days | Other | Placebo |
Primary outcome
Cerebral Blood Flow
Time frame: 1 month
1 secondary outcome
Hypoglycemia Symptom Score
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 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34282646Olawsky E, Zhang Y, Eberly LE, Helgeson ES, Chow LS. A New Analysis Tool for Continuous Glucose Monitor Data. J Diabetes Sci Technol. 2022 Nov;16(6):1496-1504. doi: 10.1177/19322968211028909. Epub 2021 Jul 20.
- Derived from this study: PubMed 26345338Moheet A, Mangia S, Kumar A, Tesfaye N, Eberly LE, Bai Y, Kubisiak K, Seaquist ER. Naltrexone for treatment of impaired awareness of hypoglycemia in type 1 diabetes: A randomized clinical trial. J Diabetes Complications. 2015 Nov-Dec;29(8):1277-82. doi: 10.1016/j.jdiacomp.2015.08.004. Epub 2015 Aug 12.
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type1diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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 1/2 study testing Naltrexone in people with Type 1 Diabetes and Hypoglycemia Unawareness, 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 4 inclusion and 5 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 5 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 12 Sep 2014). 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?
Cerebral Blood Flow (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 NCT01053078, which also lists 2 linked publications.
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 5 Feb 2020.