RecruitingNot applicable

Lipoprotein Kinetics in T1D

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how type 1 diabetes raises the risk of heart attack and stroke. It compares how the body handles certain fats and fat-carrying proteins in adults with type 1 diabetes and healthy adults.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 45.
  • Have regular periods and have not reached menopause. Must not be pregnant or breastfeeding.
  • Body mass index (BMI), a measure of weight for height, must be at least 18.5 and below 30.
  • Triglycerides (a type of blood fat) must be below 150 mg/dL after fasting.
  • Healthy adults: blood sugar below 100 mg/dL after fasting and below 140 mg/dL two hours after a 75-gram sugar drink.
  • Healthy adults: HbA1c (a measure of average blood sugar) below 5.6%.
  • Adults with type 1 diabetes: same insulin treatment plan for at least 8 weeks before screening, no diabetes drugs besides insulin, and HbA1c below 8.0%.
  • Adults with type 1 diabetes: no severe low blood sugar that caused a seizure or needed help from others or a medical facility in the 6 months before screening or study testing.

Who can't join

  • More than 1.5 hours of planned exercise each week.
  • Use of tobacco, too much alcohol, or supplements or medicines known to affect how the body handles fats.
  • An underactive thyroid or another disorder known to affect how the body handles fats.
  • A condition that would make it impossible to complete the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 \<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 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 sites (1)

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