Recruiting

Observational Study

Sponsor:

University of Missouri-Columbia

Code:

NCT05179954

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Metabolic testing

Study Details

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.

Conditions

Type 1 Diabetes

Study ID

NCT05179954

Start date

May 9, 2022

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Additional inclusion criteria for control subjects:

  • Fasting plasma glucose <100 mg/dL
  • Plasma glucose 2 h after a 75 g oral glucose challenge <140 mg/dL
  • HbA1c <5.6%.

Additional inclusion criteria for subjects with T1DM:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Control group

Healthy control group

active comparator: T1D group

T1D group

Interventions

Metabolic testing

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

Primary outcome measure

  • Apolipoprotein C turnover rate [ Time Frame: one time, at baseline (this is a cross-sectional, observational study, no intervention) ]

Central Contacts and Locations

Central contacts

Amanda Heider

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

Mittendorfer Lab

MittendorferLab@umsystem.edu

Locations

University of Missouri School of Medicine

Recruiting

Columbia, Missouri, United States, 65212

Contacts

Bettina Mittendorfer, PhD

b.mittendorfer@missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2026-02-10.