Type 1 DiabetesLTDNCT05179954
Lipoprotein Kinetics in T1D
A study testing Metabolic testing in people with Type 1 Diabetes, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Metabolic testing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mittendorfer Lab contact
United States1 site, 1 recruiting
- Recruiting
University of Missouri School of Medicine
Columbia, Missouri, 65212
Bettina Mittendorfer, PhD, b.mittendorfer@missouri.edu
About this study
Official title: Apolipoprotein C3-loading of Apolipoprotein B100 Lipoproteins and Cardiovascular Disease in Patients With Type 1 Diabetes
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.
Read the detailed description
Not required
- Conditions
- Type 1 Diabetes
- Being tested
- Metabolic testing
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolic testingOther
Participants will complete a metabolic testing protocol that includes intravenous infusion of stable isotope labeled tracers and blood sampling to determine lipoprotein kinetics
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Healthy control group Receives: Other: Metabolic testing |
| T1D group | Active comparator | T1D group Receives: Other: Metabolic testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apolipoprotein C turnover rate
Apolipoprotein C turnover rate will be assessed by using an intravenous stable isotope labeled amino acid infusion
Measured: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Secondary outcomes (5)
Triglyceride turnover rate
Triglyceride turnover rate will be assessed by using an intravenous stable isotope labeled glycerol infusion
Measured: 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
Measured: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Apolipoprotein C concentration
Apolipoprotein C concentration
Measured: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Triglyceride concentration
Triglyceride concentration
Measured: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Apolipoprotein B-100 concentration
Apolipoprotein B-100 concentration
Measured: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start9 May 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cross-sectional comparison (T1D vs healthy control)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington
- Responsible party
- Principal investigator, Bettina Mittendorfer, University of Missouri-Columbia
- Investigators
- Bettina Mittendorfer, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179954
- Sponsor's protocol ID
- 2097324
- Acronym
- LTD
- Status last verified
- Feb 2026
- First submitted
- 22 Nov 2021
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apolipoprotein C3-loading of Apolipoprotein B100 Lipoproteins and Cardiovascular Disease in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05179954
- Acronym / sponsor ID
- LTD / 2097324
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- University of Washington
- Study start
- 9 May 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cross-sectional comparison (T1D vs healthy control)
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Metabolic testingHealthy control group |
| T1D group | Active comparator | Other: Metabolic testingT1D group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
- Fasting plasma glucose <100 mg/dL
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolic testingParticipants will complete a metabolic testing protocol that includes intravenous infusion of stable isotope labeled tracers and blood sampling to determine lipoprotein kinetics | Other | Control group, T1D group |
Primary outcome
Apolipoprotein C turnover rate
Time frame: 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
5 secondary outcomes
Triglyceride turnover rate
Time frame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Apolipoprotein B-100 turnover rate
Time frame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Apolipoprotein C concentration
Time frame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Triglyceride concentration
Time frame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Apolipoprotein B-100 concentration
Time frame: one time, at baseline (this is a cross-sectional, observational study, no intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be available upon reasonable request
Related trials for Type 1 Diabetes
Recruiting
C-Carbs: A CGM-guided Approach to Teaching Carb Awareness
Type 1 Diabetes
RecruitingPhase 3
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
CKM For Safe Use of SGLT2i in Type 1 Diabetes
Type 1 Diabetes (T1D)
Active, not recruitingPhase 1
Islet Transplantation Alone (ITA) in Patients With Difficult to Control Type I Diabetes Mellitus Using a Glucocorticoid-free Immunosuppressive Regimen
Diabetes Mellitus
RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mittendorfer Lab contact
Bettina Mittendorfer principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metabolic testing in people with Type 1 Diabetes, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Heider ((573) 884-6852, ahmc4@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apolipoprotein C turnover rate (time frame: one time, at baseline (this is a cross-sectional, observational study, no intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.