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NCT Number: NCT05179954

Lipoprotein Kinetics in T1D

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri School of Medicine

Columbia, Missouri, 65212, United States

Location status: Recruiting

Location contact

Bettina Mittendorfer, PhD

CONTACT

[email protected]

About this study

Not required

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metabolic testing

Other

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

Primary outcomes

  1. Apolipoprotein C turnover rate

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

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

Secondary outcomes

  1. Triglyceride turnover rate

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

    Triglyceride turnover rate will be assessed by using an intravenous stable isotope labeled glycerol infusion

  2. Apolipoprotein B-100 turnover rate

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

    Apolipoprotein B-100 turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion

  3. Apolipoprotein C concentration

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

    Apolipoprotein C concentration

  4. Triglyceride concentration

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

    Triglyceride concentration

  5. Apolipoprotein B-100 concentration

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

    Apolipoprotein B-100 concentration

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Heider

CONTACT

[email protected]

(573) 884-6852

Mittendorfer Lab

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • University of Washington

Registry information

Official study title

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

Acronym: LTD

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2022
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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