Understanding lipoprotein kinetics in type 1 diabetes
Apolipoprotein C3-loading of Apolipoprotein B100 Lipoproteins and Cardiovascular Disease in Patients With Type 1 Diabetes
This study is testing how type 1 diabetes affects fat and protein levels in the blood to see if it raises the risk of heart problems compared to healthy people.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT05179954 on ClinicalTrials.gov |
What this trial studies
This research aims to investigate how type 1 diabetes (T1D) affects the risk of cardiovascular diseases by comparing the kinetics of apolipoproteins and triglycerides in individuals with T1D to healthy controls. Participants will undergo metabolic testing to gather data on lipid metabolism. The study will include adults aged 18 to 45, focusing on those with stable insulin regimens and specific health criteria. Control subjects will also be carefully selected based on their glucose levels and overall health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 45 with type 1 diabetes who meet specific health criteria.
Not a fit: Patients who are obese, have uncontrolled diabetes, or engage in excessive exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the cardiovascular risks associated with type 1 diabetes, potentially leading to improved management strategies.
How similar studies have performed: While studies on lipid metabolism in diabetes exist, this specific approach focusing on lipoprotein kinetics in T1D is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 \<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
Where this trial is running
Columbia, Missouri
- University of Missouri School of Medicine — Columbia, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Bettina Mittendorfer — University of Missouri-Columbia
- Study coordinator: Amanda Heider
- Email: ahmc4@health.missouri.edu
- Phone: (573) 884-6852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.