Metabolic Phenotypes and Heterogeneity in Disease Burden... | NCT05609279

Studies
Metabolic Phenotypes and Heterogeneity in Disease Burden Risk in Type 1 Diabetes

NCT05609279

Sponsor

University of Michigan

Status

Completed

Last Update Posted

Dec 13, 2024Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Diabetes Mellitus

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 18, 2021Actual

Primary Completion Date

Aug 30, 2024Actual

Completion Date

Aug 30, 2024Actual

First Submitted Date

Nov 1, 2022

First Submission Date that Met QC Criteria

Nov 1, 2022

First Posted Date

Nov 8, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2024

Last Update Posted Date

Dec 13, 2024Actual

Name	Class
Juvenile Diabetes Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study focuses on individuals with type 1 diabetes (T1D) and seeks to comprehensively study and understand several aspects of T1D including: susceptibility to hypoglycemia (low blood sugar) and improvement in hypoglycemia risk using of advanced diabetes technologies, such as continuous glucose monitoring (CGM); the differences among individuals with T1D in the risk of chronic complications, and minimize the psychosocial impact of T1D.

Detailed Description

The study seeks to comprehensively study and understand several aspects of type 1 diabetes (T1D) including: the risk of low blood sugar and how that may be improved with new technologies; the variability (heterogeneity) among individuals in their risk of diabetes complications, and factors that could impact the psychosocial burdens of having T1D. The investigators want to learn of there are patient-specific systemic metabolomic profiles (substances detected in blood or urine) that lower the risk for hypoglycemia. Metabolomic analyses will be used to discover biological markers that could predict who is most likely to get diabetes complications, and how these risks might be changed, for example, by developing treatments targeted specifically to those biological markers. The investigators also plan to describe the relationship between metabolomic profiles, psychosocial states and cognitive function.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of enrolled participants providing serum samples for metabolomic analysis	Metabolomic samples will be requested from all study participants at the first (Visit 1) and last (Visit 3) study visit. The last study visit will be within 3 years of the first.	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All participants with type 1 diabetes
Previous enrollment and participation in the University of Michigan T1D cohorts (Natural History of Myocardial Dysfunction in T1D (HUM00036408); Targeting Inflammation with Salsalate in a T1D(HUM00169353); Preventing Early Renal Loss with Allopurinol in T1D (HUM00080944); and Tissue Specific Metabolic Reprogramming (HUM00060967)).
Willing and able to participate in the study procedures described in the consent form.
Willing to sign a written or electronic informed consent, including authorization to release health information.
Fluent in spoken and written English.
Willing to carry around their mobile phone/study mobile phone during the 14-day home monitoring period with daily access to cellular or WiFi connectivity.

Exclusion Criteria:

Any social or medical condition that would, in the opinion of the Principal Investigator (PI), prevent complete participation in the study or would pose significant hazard to the subject's participation.
Skin conditions or diseases that would interfere with the Continuous Glucose Monitor (CGM) sensor placement or accuracy (such as extensive psoriasis, extensive eczema, scarring, etc.)
Scheduled X-ray, MRI, CT scan, or high-frequency electrical heat (diathermy) treatment during the period of CGM wear (or any other activity that would necessitate CGM sensor removal) that cannot be scheduled around or accommodated within the study assessment windows.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All participants with type 1 diabetes previously enrolled and that participated in the University of Michigan T1D cohorts

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan		Ann Arbor	Michigan	48109	United States

ID	Term
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Description

Laboratory Measures:

Blood and urine will be obtained for several laboratory tests including hemoglobin A1c (HbA1c), Lipid panel, Kidney Function. Urine will be obtained for urine microalbumin and protein measurements.

Biosamples collection:

Fasting blood and urine will also be collected for biomarkers assessments. With participant approval the study team will store sample for unspecified future research. This future research may involve DNA testing. Total blood storage at each in person visit will be 15mL. Total urine storage at each in person visit will be 50mL.