Type I DiabetesNCT01623388
Epigenetic Modifications of Diabetes Mellitus Type I
An observational study of Type I Diabetes, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
This research is being done to find out if significant changes in blood glucose cause bad outcomes in patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type I Diabetes
- What is being tested?
- Oral glucose tolerance test for Phase I
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jan 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Type I Diabetic
Who may be able to join
- 18-65 years old
- Diagnosis of Type I diabetes
- Willing to wear continuous blood glucose monitor as specified in protocol
Who cannot join
- Pregnant or planning to become pregnant during the study
- Healthy control group Inclusion:
- 18-65 years old
- Willing to wear continuous blood glucose monitor as specified in protocol
- Pregnant or planning to become pregnant during the study
- Diagnosis of Type I or II Diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epigenetic Modifications Induced by Glycemic Variability
This research is being done to find out if significant changes in blood glucose cause bad outcomes in patients with diabetes.
- Conditions
- Type I Diabetes
- Being tested
- Oral glucose tolerance test for Phase I
- 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.
Oral glucose tolerance test for Phase IProcedure or surgery
Oral glucose tolerance test for Diabetic patients in phase I
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Not described Receives: Procedure: Oral glucose tolerance test for Phase I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate blood sugar variability in Type I diabetics for differences in epigenetic signatures between Type I diabetics with little glycemic variability as compared to those with more pronounced glycemic changes.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type I 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623388
- Sponsor's protocol ID
- 11-5649
- Status last verified
- Jan 2014
- First submitted
- 7 Jun 2012
- Last updated
- 9 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Modifications Induced by Glycemic Variability
- ClinicalTrials.gov ID
- NCT01623388
- Acronym / sponsor ID
- 11-5649
- Conditions
- Type I Diabetes
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- First posted
- 20 Jun 2012 (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.
This research is being done to find out if significant changes in blood glucose cause bad outcomes in patients with diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I | – | Procedure: Oral glucose tolerance test for Phase I |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type I Diabetic
Key inclusion criteria (3 listed)
- 18-65 years old
- Diagnosis of Type I diabetes
- Willing to wear continuous blood glucose monitor as specified in protocol
Key exclusion criteria (6 listed)
- Pregnant or planning to become pregnant during the study
- 18-65 years old
- Willing to wear continuous blood glucose monitor as specified in protocol
- Pregnant or planning to become pregnant during the study
- Diagnosis of Type I or II Diabetes
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 |
|---|---|---|
| Oral glucose tolerance test for Phase IOral glucose tolerance test for Diabetic patients in phase I | Procedure or surgery | Phase I |
Primary outcome
Evaluate blood sugar variability in Type I diabetics for differences in epigenetic signatures between Type I diabetics with little glycemic variability as compared to those with more pronounced glycemic changes.
Time frame: 7 days
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 9 Jan 2014.
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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.
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?
An observational study of Type I Diabetes, run by Scripps Translational Science Institute 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 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: withdrawn, as of the sponsor's last update on 9 Jan 2014. 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?
Evaluate blood sugar variability in Type I diabetics for differences in epigenetic signatures between Type I diabetics with little glycemic variability as compared to those with more pronounced glycemic changes. (time frame: 7 days). 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 9 Jan 2014.