Diabetes Mellitus Type 1NCT00896610
Natural History of Autoimmune Diabetes and Its Complications
An observational study of Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Diabetes is a disease defined by abnormally high blood sugar (glucose) levels. Glucose is an essential source of energy for the body s cells, but insulin is required to move the glucose into the cells. Insulin is a hormone produced by the pancreas that allows glucose to enter cells. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Type 1, Diabetes Mellitus Type 2
- How many people
- 356 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2009to 30 Sep 2020
- 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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Individuals who have been diagnosed with or are at risk for developing diabetes
Who may be able to join
None listed.
Who cannot join
- Concomitant medical problems which would confound the interpretation studies of the autoimmune beta cell destructive process
- Concomitant medical, surgical, or other conditions for which adequate facilities or funds are not available to support their care at the NIH.
- Any other co-existing condition/circumstances that would make a subject unsuitable to participate in the study, as deemed by the investigators.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background:
- Diabetes is a disease defined by abnormally high blood sugar (glucose) levels. Glucose is an essential source of energy for the body s cells, but insulin is required to move the glucose into the cells. Insulin is a hormone produced by the pancreas that allows glucose to enter cells.
- In diabetes, the body is unable to supply enough insulin to meet its demands. The problem may be a low supply of insulin or a high demand for insulin. Someone who has been diagnosed with diabetes has lost much of their insulin-producing capacity. Clinical studies have shown that good control of blood sugar is essential to prevent diabetes complications like damage to the eyes, kidneys, nerves, and blood vessels.
Read more
Objectives:
- To establish a relationship with several individuals with diabetes caused by the immune system attacking the body s insulin-producing cells in order to:
- Explore why the immune system attacks insulin-producing cells.
- Understand why some individuals develop diabetes-related complications and others do not.
- Develop therapies to improve how patients can control their blood sugar levels.
- Continue to follow subjects who have completed or are considering other NIH diabetes-related studies.
- To develop improved tests for determining an individual s risk for developing diabetes and/or to accurately diagnose the exact type of diabetes.
Eligibility:
- Individuals who have been diagnosed with or are at risk for developing diabetes.
Design:
- Standard physical examination and clinical tests to determine if the patient has diabetes or to confirm a particular type of diabetes:
- None of the treatment in this study is experimental.
- Patients will receive a separate consent form for any special tests needed to learn more about their particular type of diabetes.
- Patients may be asked to provide additional urine and blood samples for use in laboratory research about diabetes.
- Researchers may offer medical treatment advice for diabetes, or explain how to improve patients diabetes management skills.
Read the detailed description
Individuals with known or suspected autoimmune mediated diabetes, or healthy individuals at risk for developing the disease, will be evaluated at the NIH Clinical Center. Studies will include characterizing the disease s clinical and laboratory features, observing the natural history of the disease and its complications, evaluating responses to standard treatments. Protocol enrollees may be asked to contribute blood and/or urine samples for immunological research studies, and/or for studies designed to find parameters that increase a subject s risk for diabetes and/or its associated complications.
- Conditions
- Diabetes Mellitus Type 1, Diabetes Mellitus Type 2
- Keywords
- Diabetes Type II, Diabetes Type 1, Autoimmunity, Type 1 Diabetes, Type 2 Diabetes, Autoimmune Diabetes, At Risk Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Autoimmune Diseases
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 |
|---|---|---|
| Diabetes | Individuals who have been diagnosed with or are at risk for developing diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose level
Blood glucose level within a range appropriate for the patient's condition.
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2009 (estimated)
- Study start13 May 2009
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Why it stopped: All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Time perspective
- Prospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ranganath Muniyappa, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896610
- Sponsor's protocol ID
- 090140
- Other IDs
- 09-DK-0140
- Status last verified
- Oct 2020
- First submitted
- 8 May 2009
- Last updated
- 8 Oct 2020
- Results posted
- No
Publications
Harlan DM, von Herrath M. Immune intervention with anti-CD3 in diabetes. Nat Med. 2005 Jul;11(7):716-8. doi: 10.1038/nm0705-716. No abstract available.
PubMed 16015359Haines L, Wan KC, Lynn R, Barrett TG, Shield JP. Rising incidence of type 2 diabetes in children in the U.K. Diabetes Care. 2007 May;30(5):1097-101. doi: 10.2337/dc06-1813. Epub 2007 Jan 26.
PubMed 17259470Palmer JP, Hampe CS, Chiu H, Goel A, Brooks-Worrell BM. Is latent autoimmune diabetes in adults distinct from type 1 diabetes or just type 1 diabetes at an older age? Diabetes. 2005 Dec;54 Suppl 2:S62-7. doi: 10.2337/diabetes.54.suppl_2.s62.
PubMed 16306342Lo B, Swafford AD, Shafer-Weaver KA, Jerome LF, Rakhlin L, Mathern DR, Callahan CA, Jiang P, Davison LJ, Stevens HE, Lucas CL, White J, von Borstel R, Todd JA, Lenardo MJ. Antibodies against insulin measured by electrochemiluminescence predicts insulitis severity and disease onset in non-obese diabetic mice and can distinguish human type 1 diabetes status. J Transl Med. 2011 Nov 28;9:203. doi: 10.1186/1479-5876-9-203.
PubMed 22123298
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Autoimmune Diabetes and Its Complications
- ClinicalTrials.gov ID
- NCT00896610
- Acronym / sponsor ID
- 090140
- Conditions
- Diabetes Mellitus Type 1, Diabetes Mellitus Type 2
- Keywords
- Diabetes Type II, Diabetes Type 1, Autoimmunity, Type 1 Diabetes, Type 2 Diabetes, Autoimmune Diabetes, At Risk Diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data
- Enrolment
- 356 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 13 May 2009 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 11 May 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.
Background:
- Diabetes is a disease defined by abnormally high blood sugar (glucose) levels. Glucose is an essential source of energy for the body s cells, but insulin is required to move the glucose into the cells. Insulin is a hormone produced by the pancreas that allows glucose to enter cells.
- In diabetes, the body is unable to supply enough insulin to meet its demands. The problem may be a low supply of insulin or a high demand for insulin. Someone who has been diagnosed with diabetes has lost much of their insulin-producing capacity. Clinical studies have shown that good control of blood sugar is essential to prevent diabetes complications like damage to the eyes, kidneys, nerves, and blood vessels.
Objectives:
- To establish a relationship with several individuals with diabetes caused by the immune system attacking the body s insulin-producing cells in order to:
- Explore why the immune system attacks insulin-producing cells.
- Understand why some individuals develop diabetes-related complications and others do not.
- Develop therapies to improve how patients can control their blood sugar levels.
- Continue to follow subjects who have completed or are considering other NIH diabetes-related studies.
- To develop improved tests for determining an individual s risk for developing diabetes and/or to accurately diagnose the exact type of diabetes.
Eligibility:
- Individuals who have been diagnosed with or are at risk for developing diabetes.
Design:
- Standard physical examination and clinical tests to determine if the patient has diabetes or to confirm a particular type of diabetes:
- None of the treatment in this study is experimental.
- Patients will receive a separate consent form for any special tests needed to learn more about their particular type of diabetes.
- Patients may be asked to provide additional urine and blood samples for use in laboratory research about diabetes.
- Researchers may offer medical treatment advice for diabetes, or explain how to improve patients diabetes management skills.
Detailed description
Individuals with known or suspected autoimmune mediated diabetes, or healthy individuals at risk for developing the disease, will be evaluated at the NIH Clinical Center. Studies will include characterizing the disease s clinical and laboratory features, observing the natural history of the disease and its complications, evaluating responses to standard treatments. Protocol enrollees may be asked to contribute blood and/or urine samples for immunological research studies, and/or for studies designed to find parameters that increase a subject s risk for diabetes and/or its associated complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes | – | –Individuals who have been diagnosed with or are at risk for developing diabetes |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals who have been diagnosed with or are at risk for developing diabetes
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Concomitant medical problems which would confound the interpretation studies of the autoimmune beta cell destructive process
- Concomitant medical, surgical, or other conditions for which adequate facilities or funds are not available to support their care at the NIH.
- Any other co-existing condition/circumstances that would make a subject unsuitable to participate in the study, as deemed by the investigators.
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
Blood glucose level
Time frame: every 3 months
Blood glucose level within a range appropriate for the patient's condition.
Results and safety
The study was stopped early (reason given: All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 16015359Harlan DM, von Herrath M. Immune intervention with anti-CD3 in diabetes. Nat Med. 2005 Jul;11(7):716-8. doi: 10.1038/nm0705-716. No abstract available.
- Background: PubMed 17259470Haines L, Wan KC, Lynn R, Barrett TG, Shield JP. Rising incidence of type 2 diabetes in children in the U.K. Diabetes Care. 2007 May;30(5):1097-101. doi: 10.2337/dc06-1813. Epub 2007 Jan 26.
- Background: PubMed 16306342Palmer JP, Hampe CS, Chiu H, Goel A, Brooks-Worrell BM. Is latent autoimmune diabetes in adults distinct from type 1 diabetes or just type 1 diabetes at an older age? Diabetes. 2005 Dec;54 Suppl 2:S62-7. doi: 10.2337/diabetes.54.suppl_2.s62.
- Derived from this study: PubMed 22123298Lo B, Swafford AD, Shafer-Weaver KA, Jerome LF, Rakhlin L, Mathern DR, Callahan CA, Jiang P, Davison LJ, Stevens HE, Lucas CL, White J, von Borstel R, Todd JA, Lenardo MJ. Antibodies against insulin measured by electrochemiluminescence predicts insulitis severity and disease onset in non-obese diabetic mice and can distinguish human type 1 diabetes status. J Transl Med. 2011 Nov 28;9:203. doi: 10.1186/1479-5876-9-203.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Ranganath Muniyappa, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 0 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 8 Oct 2020. 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 stopped early (reason given: All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data). 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?
Blood glucose level (time frame: every 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00896610, which also lists 4 linked publications.
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 8 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.