Lipoprotein Kinetics in T1D

Type 1 Diabetes Clinical Trial

— LTD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179954
• Other study ID #: 2097324
• Status: Recruiting
• Phase: N/A
• Start date: May 9, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2023
• Source: University of Missouri-Columbia
• Contact: Bettina Mittendorfer
• Phone: 314-362-8540
• Email: mittendb[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not required

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Metabolic testing
Participants will complete a metabolic testing protocol that includes intravenous infusion of stable isotope labeled tracers and blood sampling to determine lipoprotein kinetics

Locations

Country	Name	City	State
United States	University of Missouri School of Medicine	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Apolipoprotein C concentration	Apolipoprotein C concentration	one time, at baseline (this is a cross-sectional, observational study, no intervention)
Secondary	Triglyceride concentration	Triglyceride concentration	one time, at baseline (this is a cross-sectional, observational study, no intervention)
Secondary	Apolipoprotein B-100 concentration	Apolipoprotein B-100 concentration	one time, at baseline (this is a cross-sectional, observational study, no intervention)