Molecular Quantification of Insulin mRNA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. determine the identity of the white cell responsible for expression of insulin mRNA and
4. determine protein expression of mRNA of insulin/proinsulin and selected genes of white cell activation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes

NCT04585776

Type 1 Diabetes

COMPLETED PHASE2

Expanding Coverage of Continuous Subcutaneous Insulin Infusion in Pediatric Patients With Diabetes

NCT00829062

Type 1 Diabetes

WITHDRAWN NA

The Use of Mini-dose Glucagon to Prevent Exercise-induced Hypoglycemia in Type 1 Diabetes

NCT02660242

Diabetes Mellitus, Type 1

COMPLETED PHASE2

Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting

NCT01401751

Type 1 Diabetes Mellitus

COMPLETED NA

Effect of Anakinra on Insulin Sensitivity in Type 1 Diabetes Mellitus

NCT01285245

Diabetes Mellitus

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. normal animals
2. after islet cell transplantation
3. hyperglycemic induced expression and
4. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Type 1 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female subjects ages 1 to 17 years of age
2. Subjects with evidence of beta cell dysfunction or evidence of beta cell autoimmunity
3. Subjects with new onset type 1 diabetes
4. Non-diabetic and autoantibody negative siblings of subjects with new onset type 1 diabetes
5. Unrelated nondiabetic controls with no family history of type 1 diabetes
6. Of sufficient size to donate 10ml of blood

Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes