Lipoprotein Kinetics in T1D

Study Overview
=================
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

Official Title
-----------------
Apolipoprotein C3-loading of Apolipoprotein B100 Lipoproteins and Cardiovascular Disease in Patients With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: Metabolic testing


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cross-sectional comparison (T1D vs healthy control)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>Healthy control group | Other: Metabolic testing<br>* Participants will complete a metabolic testing protocol that includes intravenous infusion of stable isotope labeled tracers and blood sampling to determine lipoprotein kinetics<br>|
| Active Comparator: T1D group<br>T1D group | Other: Metabolic testing<br>* Participants will complete a metabolic testing protocol that includes intravenous infusion of stable isotope labeled tracers and blood sampling to determine lipoprotein kinetics<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apolipoprotein C turnover rate | Apolipoprotein C turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion | one time, at baseline (this is a cross-sectional, observational study, no intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triglyceride turnover rate | Triglyceride turnover rate will be assessed by using an intravenous stable isotope labeled glycerol infusion | one time, at baseline (this is a cross-sectional, observational study, no intervention) | 
| Apolipoprotein B-100 turnover rate | Apolipoprotein B-100 turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion | one time, at baseline (this is a cross-sectional, observational study, no intervention) | 
| Apolipoprotein C concentration | Apolipoprotein C concentration | one time, at baseline (this is a cross-sectional, observational study, no intervention) | 
| Triglyceride concentration | Triglyceride concentration | one time, at baseline (this is a cross-sectional, observational study, no intervention) | 
| Apolipoprotein B-100 concentration | Apolipoprotein B-100 concentration | one time, at baseline (this is a cross-sectional, observational study, no intervention) |