Development of Predictive Biomarkers

NCT ID: NCT03423862

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2021-09-30

Brief Summary

Investigators aim to further the understanding of the various factors that govern the progression of beta-cell death in individuals recently diagnosed with Type 1 diabetes (T1D). Specifically, the investigators wish to examine the utility of plasma-induced signatures and other measures as predictive biomarkers for the rate of C-peptide decline in individuals with recent onset T1D. Persistent C-peptide in individuals with T1D reflects some degree of β-cell function and is clinically associated with a reduction in both severe hypoglycemic events and microvascular complications such as diabetic nephropathy and retinopathy. There is significant heterogeneity in the rate of C-peptide decline in individuals with T1D, reflective of the complex disease process. For example, ~10% of individuals have no discernable fall in stimulated C-peptide after two years from clinical diagnosis as compared to other individuals with very rapid C-peptide decline. It is currently impossible to predict how long, and to what extent, someone will have residual C-peptide production. This complicates clinical management but also the design and interpretation of T1D β-cell preservation trials. The "gold standard" outcome measure of any T1D β-cell preservation trial is the stimulated C-peptide to a mixed meal tolerance test (MMTT). Given the variability in this measure, intervention studies must include more subjects over a longer period of time. This slows the rate of scientific discovery and increases cost. This study aims to define the governing mechanisms of post-onset T1D disease trajectory. Understanding the trajectory of the disease may lead to the development of biomarkers to predict disease progression and therapies that could reverse or prevent the development of Type 1 diabetes.

Conditions

Type1diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Mixed Meal Tolerance Test

After a 10-hour overnight fast (not eating or drinking anything except water), participants will complete a mixed meal tolerance test (MMTT):

This involves participants drinking a "Boost" drink, like a milkshake, which will raise participants' blood sugar.

The amount of "Boost" will be based on participants body weight, up to a maximum of 360 mL or about 1 ½ cups, and should be consumed within 5 minutes.

An IV will be placed in participants arm and blood will be drawn from it. Blood will be drawn from the IV before and then 6 times over the next 2 hours after participants drink the "Boost".

Intervention Type: OTHER

Other Intervention Names

MMTT

Eligibility Criteria

Inclusion Criteria

1. Males and females 5-17 years of age with a clinical diagnosis of T1D

2. T1D diagnosis date between 1-3 months at the time of study visit 2 (baseline visit)

3. Treatment naïve of any immunomodulatory agent

4. Receiving routine out-patient diabetes care at the CHW Diabetes Clinic

Exclusion Criteria

1. Presence of severe, active disease that requires the use of chronic medication, with the exception of well-controlled autoimmune thyroiditis/hypothyroidism or celiac disease that is well-controlled on a gluten free diet.

2. Diabetes other than T1D

3. Chronic illness known to affect glucose metabolism

4. Psychiatric impairment, with the exception of well-controlled depression or anxiety, that will affect the ability to participate in the study

5. Female participants of child-bearing age with reproductive potential must not be knowingly pregnant

6. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Susanne Cabrera

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susanne Cabrera, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

1048169

Identifier Type: -

Identifier Source: org_study_id