Type 1 Diabetes MellitusNCT00324207
Molecular Quantification of Insulin mRNA
An observational study of Type 1 Diabetes Mellitus, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
The objectives of this study are to: 1. quantitate the level of insulin mRNA in the while cell fraction of whole blood in selected groups of subjects, 2. determine the gene expression of markers of white cell activation in the white cell fraction of whole blood in selected subjects, 3. Read more about this study
- Who is it for?
- Ages 1 year to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jan 2009
- 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 1 year to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Hospital and clinic patients and their siblings.
Who may be able to join
- Male or female subjects ages 1 to 17 years of age
- Subjects with evidence of beta cell dysfunction or evidence of beta cell autoimmunity
- Subjects with new onset type 1 diabetes
- Non-diabetic and autoantibody negative siblings of subjects with new onset type 1 diabetes
- Unrelated nondiabetic controls with no family history of type 1 diabetes
- Of sufficient size to donate 10ml of blood
Who cannot join
- None if subjects meet above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
Official title: Prediction of Type 1 Diabetes: Molecular Quantification of Insulin mRNA in the While Cell Fraction of Whole Blood
The objectives of this study are to:
- quantitate the level of insulin mRNA in the while cell fraction of whole blood in selected groups of subjects,
- determine the gene expression of markers of white cell activation in the white cell fraction of whole blood in selected subjects,
- determine the identity of the white cell responsible for expression of insulin mRNA and
- determine protein expression of mRNA of insulin/proinsulin and selected genes of white cell activation.
Read the detailed description
Indicators of active immune or chemically mediated beta cell destruction would be helpful for predicting the development and severity of autoimmune diabetes and monitoring the success of islet transplants. Currently there are no reliable indicators readily available.
Insulin mRNA in the white cell fraction of blood has been detected or elevated under several circumstances including:
- normal animals
- after islet cell transplantation
- hyperglycemic induced expression and
- during induction of diabetes with streptozotocin
The investigators propose that quantitative measurement of insulin mRNA may be an accurate, innovative and minimally invasive indicator of beta cell destruction.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, Insulin mRNA
- Medical subject headings
- Diabetes Mellitus, Type 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
- Study startFeb 2006
- Primary completionJan 2009
- Study completionJan 2009
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.
- 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Investigators
- Wayne Moore, MD, PhD, Principal investigator, Children's Mercy Hospital Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324207
- Sponsor's protocol ID
- 00006028
- Other IDs
- 00006028
- Status last verified
- Mar 2010
- First submitted
- 8 May 2006
- Last updated
- 5 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Type 1 Diabetes: Molecular Quantification of Insulin mRNA in the While Cell Fraction of Whole Blood
- ClinicalTrials.gov ID
- NCT00324207
- Acronym / sponsor ID
- 00006028
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, Insulin mRNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 May 2006 (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.
The objectives of this study are to:
- quantitate the level of insulin mRNA in the while cell fraction of whole blood in selected groups of subjects,
- determine the gene expression of markers of white cell activation in the white cell fraction of whole blood in selected subjects,
- determine the identity of the white cell responsible for expression of insulin mRNA and
- determine protein expression of mRNA of insulin/proinsulin and selected genes of white cell activation.
Detailed description
Indicators of active immune or chemically mediated beta cell destruction would be helpful for predicting the development and severity of autoimmune diabetes and monitoring the success of islet transplants. Currently there are no reliable indicators readily available.
Insulin mRNA in the white cell fraction of blood has been detected or elevated under several circumstances including:
- normal animals
- after islet cell transplantation
- hyperglycemic induced expression and
- during induction of diabetes with streptozotocin
The investigators propose that quantitative measurement of insulin mRNA may be an accurate, innovative and minimally invasive indicator of beta cell destruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Hospital and clinic patients and their siblings.
Key inclusion criteria (6 listed)
- Male or female subjects ages 1 to 17 years of age
- Subjects with evidence of beta cell dysfunction or evidence of beta cell autoimmunity
- Subjects with new onset type 1 diabetes
- Non-diabetic and autoantibody negative siblings of subjects with new onset type 1 diabetes
- Unrelated nondiabetic controls with no family history of type 1 diabetes
Key exclusion criteria (1 listed)
- None if subjects meet above inclusion criteria
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 5 Mar 2010.
Related trials for Type 1 Diabetes Mellitus
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
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.
Wayne Moore, MD, PhD principal investigator
Children's Mercy Hospital Kansas City
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 Children's Mercy Hospital Kansas City 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 6 inclusion and 1 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 5 Mar 2010. 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 5 Mar 2010.