Lipoprotein Kinetics in T1D

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Dec 16, 2021

Keywords

ClinConnect Summary

This clinical trial, called "Lipoprotein Kinetics in T1D," is exploring how type 1 diabetes (T1D) might increase the risk of heart problems, like heart attacks and strokes. Researchers will look at certain fats and proteins in the blood to see how they behave differently in people with T1D compared to healthy individuals. By understanding these differences, the study aims to shed light on why T1D can lead to cardiovascular diseases.

To participate in this study, you need to be between 18 and 45 years old, not pregnant or breastfeeding, and have a healthy body weight. If you have T1D, you should be on a stable insulin regimen for at least two months and have good blood sugar control. Healthy participants must have normal blood sugar levels. If you join the study, you'll undergo some blood tests and assessments, helping researchers gather important information. This research is currently looking for volunteers, and your participation could contribute to better understanding and management of cardiovascular risks in those with type 1 diabetes.

Gender

ALL

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 \<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