Type 1 DiabetesNCT00643110
Milk as Treatment for Hypoglycemia
A study testing D50 glucose in people with Type 1 Diabetes, run by Creighton University at 1 site in United States.
Trial summary
Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- D50 glucose
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2009
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 1 Diabetes
- Able to be consented
- Able to wear continuous glucose monitor
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do.
Read the detailed description
Subjects will wear a continuous glucose monitor prior to test to determine normal glucose levels. The morning of the test an IV will be inserted into the subject and insulin and saline drips will be started. Blood glucose levels will be checked every 10 minutes until the subject becomes hypoglycemic. IVs will be stopped at that time and subject will be given skim milk, orange juice or glucose tablets at that time. Blood will be drawn every 15 minutes until blood sugars stabilize. Blood draws will be analyzed to determine glucose, insulin, epinephrine, norepinephrine, glucagon, cortisol, growth hormone and GLP-1 levels. Procedure will be repeated two more times using other glucose methods (skim milk, orange juice or glucose tablets).
- Conditions
- Type 1 Diabetes
- Being tested
- D50 glucose
- Keywords
- 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.
D50 glucoseDrug
D50 glucose would be administered, if necessary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of 6 subjects.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Not funded
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00643110
- Sponsor's protocol ID
- Rendell 01
- Other IDs
- Dairy Council - Rendell 01
- Status last verified
- Mar 2015
- First submitted
- 20 Mar 2008
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milk as Treatment for Hypoglycemia
- ClinicalTrials.gov ID
- NCT00643110
- Acronym / sponsor ID
- Rendell 01
- Conditions
- Type 1 Diabetes
- Keywords
- Hypoglycemia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Mar 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.
Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do.
Detailed description
Subjects will wear a continuous glucose monitor prior to test to determine normal glucose levels. The morning of the test an IV will be inserted into the subject and insulin and saline drips will be started. Blood glucose levels will be checked every 10 minutes until the subject becomes hypoglycemic. IVs will be stopped at that time and subject will be given skim milk, orange juice or glucose tablets at that time. Blood will be drawn every 15 minutes until blood sugars stabilize. Blood draws will be analyzed to determine glucose, insulin, epinephrine, norepinephrine, glucagon, cortisol, growth hormone and GLP-1 levels. Procedure will be repeated two more times using other glucose methods (skim milk, orange juice or glucose tablets).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 Diabetes
- Able to be consented
- Able to wear continuous glucose monitor
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| D50 glucoseD50 glucose would be administered, if necessary. | Drug | – |
Primary outcome
Completion of 6 subjects.
Time frame: One year
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 25 Mar 2015.
Related trials for Type 1 Diabetes
Recruiting
C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
Type 1 Diabetes
RecruitingPhase 3
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
CKM For Safe Use of SGLT2i in Type 1 Diabetes
Type 1 Diabetes (T1D)
Active, not recruitingPhase 1
Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen
Diabetes Mellitus
RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D50 glucose in people with Type 1 Diabetes, run by Creighton 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 3 inclusion and 0 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 25 Mar 2015. 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 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?
Completion of 6 subjects. (time frame: One year). 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 25 Mar 2015.