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Lipoprotein Kinetics in T1D

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metabolic testing
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Washington University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Control group

T1D group

Arm Description

Healthy control group

T1D group

Outcomes

Primary Outcome Measures

Apolipoprotein C turnover rate
Apolipoprotein C turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion

Secondary Outcome Measures

Triglyceride turnover rate
Triglyceride turnover rate will be assessed by using an intravenous stable isotope labeled glycerol infusion
Apolipoprotein B-100 turnover rate
Apolipoprotein B-100 turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion
Apolipoprotein C concentration
Apolipoprotein C concentration
Triglyceride concentration
Triglyceride concentration
Apolipoprotein B-100 concentration
Apolipoprotein B-100 concentration

Full Information

First Posted
November 22, 2021
Last Updated
October 31, 2022
Sponsor
Washington University School of Medicine
Collaborators
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05179954
Brief Title
Lipoprotein Kinetics in T1D
Official Title
Apolipoprotein C3-loading of Apolipoprotein B100 Lipoproteins and Cardiovascular Disease in Patients With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cross-sectional comparison (T1D vs healthy control)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Other
Arm Description
Healthy control group
Arm Title
T1D group
Arm Type
Active Comparator
Arm Description
T1D group
Intervention Type
Other
Intervention Name(s)
Metabolic testing
Intervention Description
Participants will complete a metabolic testing protocol that includes intravenous infusion of stable isotope labeled tracers and blood sampling to determine lipoprotein kinetics
Primary Outcome Measure Information:
Title
Apolipoprotein C turnover rate
Description
Apolipoprotein C turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion
Time Frame
one time, at baseline (this is a cross-sectional, observational study, no intervention)
Secondary Outcome Measure Information:
Title
Triglyceride turnover rate
Description
Triglyceride turnover rate will be assessed by using an intravenous stable isotope labeled glycerol infusion
Time Frame
one time, at baseline (this is a cross-sectional, observational study, no intervention)
Title
Apolipoprotein B-100 turnover rate
Description
Apolipoprotein B-100 turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion
Time Frame
one time, at baseline (this is a cross-sectional, observational study, no intervention)
Title
Apolipoprotein C concentration
Description
Apolipoprotein C concentration
Time Frame
one time, at baseline (this is a cross-sectional, observational study, no intervention)
Title
Triglyceride concentration
Description
Triglyceride concentration
Time Frame
one time, at baseline (this is a cross-sectional, observational study, no intervention)
Title
Apolipoprotein B-100 concentration
Description
Apolipoprotein B-100 concentration
Time Frame
one time, at baseline (this is a cross-sectional, observational study, no intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bettina Mittendorfer
Phone
314-362-8540
Email
mittendb@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bettina Mittendorfer
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bettina Mittendorfer, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be available upon reasonable request
IPD Sharing Time Frame
5 years after completion of the study

Learn more about this trial

Lipoprotein Kinetics in T1D

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