Type One Diabetes MellitusIslet OGTTNCT00870831
Islet Function and Clinical Analyses of Transplant Recipients
An observational study of Type One Diabetes Mellitus, run by Washington University School of Medicine.
Trial summary
To follow the patterns and natural history of Islet Transplant recipients (the ones that were involved in the Modified Edmonton Protocol) using oral glucose to check sugar levels as well as insulin and C-peptide over the course of 5 years Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type One Diabetes Mellitus
- What is being tested?
- OGTT (Oral Glucose Tolerance Test)
- Type of treatment
- Pill or oral medicine
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Mar 2010
- 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 1 diabetics that have successfully received and maintained an islet transplant here at Washington University. Loss of transplant function is an exclusion criteria.
Who may be able to join
- Type 1 Diabetes with hypoglycemia unawareness that received a Islet Transplant here at Washington University
- "control" subjects were matched to the transplant recipients base upon age, height, weight, \& race (and could not have diabetes)
Who cannot join
- well controlled Type 1 diabetes
- transplant failure
- unable to match potential subject to a recipient
About this study
Official title: Islet Function and Clinical Analyses if Transplant Recipients (Project 2 of JDFI Washington University Center For Islet Transplantation) (Please Note That the JDRFI Funded Has Ended
To follow the patterns and natural history of Islet Transplant recipients (the ones that were involved in the Modified Edmonton Protocol) using oral glucose to check sugar levels as well as insulin and C-peptide over the course of 5 years
- Conditions
- Type One Diabetes Mellitus
- Being tested
- OGTT (Oral Glucose Tolerance Test)
- Keywords
- diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGTT (Oral Glucose Tolerance Test)Other
Subjects would consume 75grams of sugar (Dextrose, 10 oz) and blood samples taken at specified time points to measure glucose, insulin and C-peptide
| Study group | Role | What they receive |
|---|---|---|
| Islet Recipient | Subjects that have successfully received and maintained an Islet transplant at Washington University Center for Islet Transplantation Receives: Other: OGTT (Oral Glucose Tolerance Test) | |
| Control | subjects that were similar in height, weight and age that did NOT have diabetes to act as the comparative group Receives: Other: OGTT (Oral Glucose Tolerance Test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
OGTT will be performed every 6 months for 5 years in subjects with a functioning Islet Transplant
Measured: 5 years
Secondary outcomes (1)
The OGTT reflects the function of the Islet transplant and could be used as an indication of Islet Transplant function
Measured: 5yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startOct 2000
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: PI left University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type One 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
- Cohort
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kenneth S Polonsky, MD, Principal investigator, Washington University School of MedicineDaniel C Brennan, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870831
- Sponsor's protocol ID
- 00-0870
- Acronym
- Islet OGTT
- Status last verified
- Dec 2014
- First submitted
- 26 Mar 2009
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islet Function and Clinical Analyses if Transplant Recipients (Project 2 of JDFI Washington University Center For Islet Transplantation) (Please Note That the JDRFI Funded Has Ended
- ClinicalTrials.gov ID
- NCT00870831
- Acronym / sponsor ID
- Islet OGTT / 00-0870
- Conditions
- Type One Diabetes Mellitus
- Keywords
- diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left University
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2000
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Mar 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.
To follow the patterns and natural history of Islet Transplant recipients (the ones that were involved in the Modified Edmonton Protocol) using oral glucose to check sugar levels as well as insulin and C-peptide over the course of 5 years
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Islet Recipient | – | Other: OGTT (Oral Glucose Tolerance Test)Subjects that have successfully received and maintained an Islet transplant at Washington University Center for Islet Transplantation |
| Control | – | Other: OGTT (Oral Glucose Tolerance Test)subjects that were similar in height, weight and age that did NOT have diabetes to act as the comparative group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 diabetics that have successfully received and maintained an islet transplant here at Washington University. Loss of transplant function is an exclusion criteria.
Key inclusion criteria (2 listed)
- Type 1 Diabetes with hypoglycemia unawareness that received a Islet Transplant here at Washington University
- "control" subjects were matched to the transplant recipients base upon age, height, weight, \& race (and could not have diabetes)
Key exclusion criteria (3 listed)
- well controlled Type 1 diabetes
- transplant failure
- unable to match potential subject to a recipient
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 |
|---|---|---|
| OGTT (Oral Glucose Tolerance Test)Subjects would consume 75grams of sugar (Dextrose, 10 oz) and blood samples taken at specified time points to measure glucose, insulin and C-peptide | Other | Control, Islet Recipient |
Primary outcome
OGTT will be performed every 6 months for 5 years in subjects with a functioning Islet Transplant
Time frame: 5 years
1 secondary outcome
The OGTT reflects the function of the Islet transplant and could be used as an indication of Islet Transplant function
Time frame: 5yrs
Results and safety
The study was stopped early (reason given: PI left University). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 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.
Kenneth S Polonsky, MD principal investigator
Washington University School of Medicine
Daniel C Brennan, MD principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Type One Diabetes Mellitus, run by Washington University School of Medicine.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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 stopped early (reason given: PI left University). Results are not available in the source record.
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?
OGTT will be performed every 6 months for 5 years in subjects with a functioning Islet Transplant (time frame: 5 years). 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 10 Dec 2014; AzTrials last refreshed its copy on 6 Nov 2026.