CClinicalTrials.gg
RecruitingNCT05179954LTDUpdated Feb 10, 2026

Lipoprotein Kinetics in T1D

An interventional study of Metabolic testing in Type 1 Diabetes, sponsored by University of Missouri-Columbia. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the detailed description

Not required

02

Conditions studied

  • Type 1 Diabetes
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Control group

    Healthy control group

    Other: Metabolic testing

  • Active comparator
    T1D group

    T1D group

    Other: Metabolic testing

Interventions

  • OtherMetabolic testing

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

06

What researchers measure

Primary outcomes

  1. Apolipoprotein C turnover rate

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

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

Secondary outcomes

  1. Triglyceride turnover rate

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

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

  2. Apolipoprotein B-100 turnover rate

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

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

  3. Apolipoprotein C concentration

    Apolipoprotein C concentration

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

  4. Triglyceride concentration

    Triglyceride concentration

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

  5. Apolipoprotein B-100 concentration

    Apolipoprotein B-100 concentration

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

07

Study locations

1 of 1 sites recruiting
  • University of Missouri School of Medicine
    Columbia, Missouri 65212, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified data will be available upon reasonable request

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05179954
Lead sponsor
University of Missouri-Columbia
Collaborators
University of Washington
Responsible party
Bettina Mittendorfer (Senior Associate Dean for Research, University of Missouri-Columbia) — Principal investigator
First posted
Jan 6, 2022
Start date
May 9, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Feb 10, 2026

Study contacts

Amanda Heider
Contact
ahmc4@health.missouri.edu
(573) 884-6852
Mittendorfer Lab
Contact
MittendorferLab@umsystem.edu
Bettina Mittendorfer
principal investigator · University of Missouri-Columbia

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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