Lipoprotein Kinetics in T1D (LTD)

University of Missouri (MU)

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Other: Metabolic testing

Study type: Interventional

Funder types: Other

Identifiers

NCT05179954

2097324

Details and patient eligibility

About

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.

Full description

Not required

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Control group

Other group

Description:

Healthy control group

Treatment:

Other: Metabolic testing

T1D group

Active Comparator group

Description:

T1D group

Treatment:

Other: Metabolic testing