HypoglycemiaNCT01462227
Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
A study testing Naltrexone High Dose and Naltrexone Low Dose in people with Hypoglycemia, run by Yale University at 1 site in United States.
Trial summary
Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypoglycemia
- What is being tested?
- Naltrexone High Dose and Naltrexone Low Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2013
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) age 18-55, BMI 18-35
Who cannot join
- pregnancy
- significant diabetes complications
- liver disease, cirrhosis
- cardiac disease
- neurological disorder
- autonomic neuropathy
- kidney disease
- lactose intolerance
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. The aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.
- Conditions
- Hypoglycemia
- Being tested
- Naltrexone High Dose, Naltrexone Low Dose
- Keywords
- Hypoglycemia, Type 1 diabetes
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone High DoseDrug
Naltrexone 100mg for two administrations.
Naltrexone Low DoseDrug
Naltrexone 50mg for two administrations.
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone (higher dose) | Experimental | Naltrexone 100mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the high dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm. Receives: Drug: Naltrexone High Dose |
| Naltrexone (lower dose) | Experimental | Naltrexone 50mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the low dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm. Receives: Drug: Naltrexone Low Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose (mg/dL)
Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Measured: End of study (up to 240 minutes)
Glucose Infusion Rate (mg/kg.Min)
The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).
Measured: End of study (up to 240 minutes)
Secondary outcomes (4)
Glucagon (pg/mL)
Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Measured: End of study (up to 240 minutes)
Cortisol (ug/dL)
Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Measured: End of study (up to 240 minutes)
Epinephrine (pg/mL)
Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Measured: End of study (up to 240 minutes)
Norepinephrine (pg/mL)
Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Measured: End of study (up to 240 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2013
- Study completionOct 2013
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.
- Other trials for HypoglycemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Robert Sherwin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462227
- Sponsor's protocol ID
- HIC1006006927
- Status last verified
- Feb 2016
- First submitted
- 26 Oct 2011
- Last updated
- 18 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
- ClinicalTrials.gov ID
- NCT01462227
- Acronym / sponsor ID
- HIC1006006927
- Conditions
- Hypoglycemia
- Keywords
- Hypoglycemia, Type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 31 Oct 2011 (estimated)
- Results
- Posted 18 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. The aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone (higher dose) | Experimental | Drug: Naltrexone High DoseNaltrexone 100mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the high dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm. |
| Naltrexone (lower dose) | Experimental | Drug: Naltrexone Low DoseNaltrexone 50mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the low dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) age 18-55, BMI 18-35
Key exclusion criteria (8 listed)
- pregnancy
- significant diabetes complications
- liver disease, cirrhosis
- cardiac disease
- neurological disorder
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 |
|---|---|---|
| Naltrexone High DoseNaltrexone 100mg for two administrations. | Drug | Naltrexone (higher dose) |
| Naltrexone Low DoseNaltrexone 50mg for two administrations. | Drug | Naltrexone (lower dose) |
Primary outcome
Glucose (mg/dL)
Time frame: End of study (up to 240 minutes)
Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Glucose Infusion Rate (mg/kg.Min)
Time frame: End of study (up to 240 minutes)
The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).
4 secondary outcomes
Glucagon (pg/mL)
Time frame: End of study (up to 240 minutes)
Cortisol (ug/dL)
Time frame: End of study (up to 240 minutes)
Epinephrine (pg/mL)
Time frame: End of study (up to 240 minutes)
Norepinephrine (pg/mL)
Time frame: End of study (up to 240 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypoglycemia
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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?
A study testing Naltrexone High Dose and Naltrexone Low Dose in people with 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 1 inclusion and 8 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 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 18 Feb 2016). 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?
Glucose (mg/dL) (time frame: End of study (up to 240 minutes)). The study lists 2 primary outcomes in all. 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 18 Feb 2016.