NCT05179954

Brief Summary

The purpose of this research study is to understand how type 1 diabetes (T1D) increases the risk for cardiovascular diseases (heart attack and stroke). To this end, the investigators will compare apolipoprotein and triglyceride kinetics in people wtih T1D and healthy control participants.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2022Dec 2027

First Submitted

Initial submission to the registry

November 22, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 9, 2022

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

4.6 years

First QC Date

November 22, 2021

Last Update Submit

February 6, 2026

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Apolipoprotein C turnover rate

    Apolipoprotein C turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion

    one time, at baseline (this is a cross-sectional, observational study, no intervention)

Secondary Outcomes (5)

  • Triglyceride turnover rate

    one time, at baseline (this is a cross-sectional, observational study, no intervention)

  • Apolipoprotein B-100 turnover rate

    one time, at baseline (this is a cross-sectional, observational study, no intervention)

  • Apolipoprotein C concentration

    one time, at baseline (this is a cross-sectional, observational study, no intervention)

  • Triglyceride concentration

    one time, at baseline (this is a cross-sectional, observational study, no intervention)

  • Apolipoprotein B-100 concentration

    one time, at baseline (this is a cross-sectional, observational study, no intervention)

Study Arms (2)

Control group

OTHER

Healthy control group

Other: Metabolic testing

T1D group

ACTIVE COMPARATOR

T1D group

Other: Metabolic testing

Interventions

Metabolic testingOTHER

Participants will complete a metabolic testing protocol that includes intravenous infusion of stable isotope labeled tracers and blood sampling to determine lipoprotein kinetics

Control groupT1D group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: ≥18 but ≤45 years
  • premenopausal/eumenorrheic and not pregnant or breastfeeding
  • non-obese (body mass index ≥18.5\<30.0 kg/m2)
  • Fasting plasma triglyceride \<150 mg/dL
  • Fasting plasma glucose \<100 mg/dL
  • Plasma glucose 2 h after a 75 g oral glucose challenge \<140 mg/dL
  • HbA1c \<5.6%.
  • stable insulin regimen (multiple daily insulin injections or continuous subcutaneous insulin) for at least 8 weeks before screening
  • no use of diabetes medications other than insulin
  • HbA1c \<8.0%, basal (overnight fasted)
  • no severe symptomatic hypoglycemic event associated with a seizure or requiring help from other people or a medical facility in the 6 months prior to screening or metabolic testing

You may not qualify if:

  • more than 1.5 h of structured exercise/week
  • use of tobacco products, excessive amounts of alcohol, or dietary supplements and/or medications known to affect lipid metabolism
  • hypothyroidism or other disorders known to affect lipid metabolism
  • conditions that would make it impossible to complete the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri School of Medicine

Columbia, Missouri, 65212, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Comprehensive Metabolic Panel

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Bettina Mittendorfer

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Heider

CONTACT

(573) 884-6852ahmc4@health.missouri.edu

Mittendorfer Lab

CONTACT

MittendorferLab@umsystem.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Cross-sectional comparison (T1D vs healthy control)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Associate Dean for Research

Study Record Dates

First Submitted

November 22, 2021

First Posted

January 6, 2022

Study Start

May 9, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified data will be available upon reasonable request

Time Frame
5 years after completion of the study

Locations

US(1)