Type 1 Diabetes MellitusASSETNCT00918801
Pilot Study of Hippocampal Function in Type 1 Diabetes Mellitus (T1DM)
An observational study of Type 1 Diabetes Mellitus, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is an expansion of a previous study done to determine how thinking skills relate to hypoglycemia (low blood sugar) and certain regions of the brain in children and adolescents. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Oct 2016
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Young adults will be piloted in a sample of diabetic and non-diabetic adolescents ages 13-18.
Who may be able to join
- Age 13 - 18
- Right handed
- Diagnosis of Type 1 Diabetes OR normal sibling control
- If diabetic, then diagnosis for at least 2 years
Who cannot join
- Pregnant or lactating
- Chronic disease other than well-controlled asthma, or Hashimoto's thyroiditis.
- Other current serious medical illness
- Co-morbid psychiatric illness
- Co-morbid neurological illness
- Pre-maturity at birth
- Contraindication to MRI scan
- orthodontic braces.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Pilot Study of Hippocampal Function in T1DM
This study is an expansion of a previous study done to determine how thinking skills relate to hypoglycemia (low blood sugar) and certain regions of the brain in children and adolescents. In this study, the investigators are testing thinking skills and measuring brain activity in adolescents with and without type 1 diabetes mellitus.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- T1DM, MRI
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 Diabetes Mellitus | Adolescents ages 13-18 with T1DM | |
| Non Controls | Healthy adolescents ages 13-18 without T1DM |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startApr 2007
- Primary completionDec 2013
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamara G Hershey, PhD., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918801
- Sponsor's protocol ID
- 06-0786
- Acronym
- ASSET
- Status last verified
- Nov 2016
- First submitted
- 8 Jun 2009
- Last updated
- 10 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This was a small pilot study and consent was not obtained to share data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Hippocampal Function in T1DM
- ClinicalTrials.gov ID
- NCT00918801
- Acronym / sponsor ID
- ASSET / 06-0786
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- T1DM, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Jun 2009 (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 study is an expansion of a previous study done to determine how thinking skills relate to hypoglycemia (low blood sugar) and certain regions of the brain in children and adolescents. In this study, the investigators are testing thinking skills and measuring brain activity in adolescents with and without type 1 diabetes mellitus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes Mellitus | – | –Adolescents ages 13-18 with T1DM |
| Non Controls | – | –Healthy adolescents ages 13-18 without T1DM |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Young adults will be piloted in a sample of diabetic and non-diabetic adolescents ages 13-18.
Key inclusion criteria (4 listed)
- Age 13 - 18
- Right handed
- Diagnosis of Type 1 Diabetes OR normal sibling control
- If diabetic, then diagnosis for at least 2 years
Key exclusion criteria (8 listed)
- Pregnant or lactating
- Chronic disease other than well-controlled asthma, or Hashimoto's thyroiditis.
- Other current serious medical illness
- Co-morbid psychiatric illness
- Co-morbid neurological illness
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 10 Nov 2016.
- Individual participant dataSharing planned: No. This was a small pilot study and consent was not obtained to share data.
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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.
Tamara G Hershey, PhD. principal investigator
Washington University School of Medicine
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 Mellitus, run by Washington University School of Medicine 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 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 10 Nov 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?
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 10 Nov 2016.