Lipoprotein Kinetics in T1D (LTD)

Apolipoprotein C3-loading of Apolipoprotein B100 Lipoproteins and Cardiovascular Disease in Patients With Type 1 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Metabolic testing

Detailed Description

Not required

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda Heider; Phone Number: (573) 884-6852; Email: ahmc4@health.missouri.edu
• Study Contact Backup: Name: Mittendorfer Lab; Email: MittendorferLab@umsystem.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Recruiting
      • University of Missouri School of Medicine
      • Contact: Bettina Mittendorfer, PhD; Email: b.mittendorfer@missouri.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Healthy control group	Other: 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
Active Comparator: T1D group	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Triglyceride turnover rate	Triglyceride turnover rate will be assessed by using an intravenous stable isotope labeled glycerol infusion	one time, at baseline (this is a cross-sectional, observational study, no intervention)
Apolipoprotein B-100 turnover rate	Apolipoprotein B-100 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)
Apolipoprotein C concentration	Apolipoprotein C concentration	one time, at baseline (this is a cross-sectional, observational study, no intervention)
Triglyceride concentration	Triglyceride concentration	one time, at baseline (this is a cross-sectional, observational study, no intervention)
Apolipoprotein B-100 concentration	Apolipoprotein B-100 concentration	one time, at baseline (this is a cross-sectional, observational study, no intervention)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: University of Washington
• Investigators: Principal Investigator: Bettina Mittendorfer, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Comprehensive Metabolic Panel
• Other Study ID Numbers: 2097324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be available upon reasonable request
• IPD Sharing Time Frame: 5 years after completion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No