Lipoprotein Kinetics in T1D

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes
• Interventions: Other: Metabolic testing

• Registration Number: NCT05179954
• Lead Sponsor: University of Missouri-Columbia

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

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-06
• Study Start: 2022-05-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
T1D group	Metabolic testing	T1D group
Control group	Metabolic testing	Healthy control group

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Missouri School of Medicine; 🇺🇸 Columbia, Missouri, United States