Clinical trial NCT05179954: Lipoprotein Kinetics in T1D
Official title: Apolipoprotein C3-loading of Apolipoprotein B100 Lipoproteins and Cardiovascular Disease in Patients with Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: University of Washington
First posted: 2022-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross-sectional comparison (T1D vs healthy control)
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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 \<6.5%, 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

Primary outcomes:
measure: Apolipoprotein C turnover rate
timeFrame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Secondary outcomes:
measure: Triglyceride turnover rate
timeFrame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
measure: Apolipoprotein B-100 turnover rate
timeFrame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
measure: Apolipoprotein C concentration
timeFrame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
measure: Triglyceride concentration
timeFrame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
measure: Apolipoprotein B-100 concentration
timeFrame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri School of Medicine
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Bettina Mittendorfer
role: PRINCIPAL_INVESTIGATOR
References: