Understanding lipoprotein kinetics in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.