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Lipoprotein Kinetics in T1D

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05179954
Acronym
LTD
Enrollment
30
Registered
2022-01-06
Start date
2022-05-09
Completion date
2027-12-31
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

Detailed description

Not required

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

Sponsors

University of Missouri-Columbia
Lead SponsorOTHER
University of Washington
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Cross-sectional comparison (T1D vs healthy control)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Apolipoprotein C turnover rateone 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

MeasureTime frameDescription
Triglyceride turnover rateone 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
Apolipoprotein B-100 turnover rateone 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
Apolipoprotein C concentrationone time, at baseline (this is a cross-sectional, observational study, no intervention)Apolipoprotein C concentration
Triglyceride concentrationone time, at baseline (this is a cross-sectional, observational study, no intervention)Triglyceride concentration
Apolipoprotein B-100 concentrationone time, at baseline (this is a cross-sectional, observational study, no intervention)Apolipoprotein B-100 concentration

Countries

United States

Contacts

CONTACTAmanda Heider
ahmc4@health.missouri.edu(573) 884-6852
CONTACTMittendorfer Lab
MittendorferLab@umsystem.edu
PRINCIPAL_INVESTIGATORBettina Mittendorfer

University of Missouri-Columbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026