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RecruitingPhase 2

Therapeutic Strategies for Microvascular Dysfunction in 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 40 Years
Sex
All sexes
Healthy volunteers
Not 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

  • Procedures mentioned: Ultrasound, Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Vascular testing will include contrast enhanced ultrasound of quadriceps muscle to determine microvascular blood volume (MBV)."
  • "These vascular and muscle oxygenation measurements will be conducted before and after a 120-minute euglycemic insulin clamp which will measure insulin sensitivity based on glucose infusion rate (GIR)."
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 tests whether dulaglutide helps insulin improve blood flow through tiny blood vessels in muscles. It will study whether the drug does this by reducing damage to the lining of blood vessels. The study is for adults ages 18–40 who have had type 1 diabetes for more than 5 years.

The investigators will test the hypothesis that, in adults with type 1 diabetes (T1D), glucagon-like peptide-1 receptor agonism (GLP-1RA, i.e. dulaglutide) enhances insulin-mediated skeletal muscle microvascular perfusion via attenuating endothelial oxidative stress and thereby improving endothelial function.

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

Eligibility

Who can join

  • Have had type 1 diabetes for more than 5 years.
  • Are 18–40 years old.
  • Have an HbA1c below 8.5%. This test shows your average blood sugar over time.
  • Have a BMI of 19–34.9. BMI measures body size based on height and weight.
  • Use only insulin to treat diabetes, through daily shots or a pump, with or without a blood sugar sensor.
  • Have had no changes to medicines for conditions other than diabetes for the past 6 months.
  • Have screening lab results that are normal or do not show important health concerns.
  • Speak English or Spanish.

Who can't join

  • Are pregnant or breastfeeding, or have smoked within the past 6 months.
  • Have diabetes-related damage to the kidneys, eyes, nerves, heart, or blood vessels, or a history of stroke; or have serious problems with the heart's rhythm or electrical signals.
  • Take medicines that affect blood vessels, such as calcium channel blockers, ACE or renin inhibitors, angiotensin-receptor blockers, nitrates, or alpha-blockers; or have a known allergy to perflutren, an ingredient in Definity imaging contrast.
  • Have a screening blood oxygen level below 90%, a muscle or bone condition that prevents exercise tests or training, or another illness that is sudden or not stable.
  • Cannot sense when blood sugar is too low; have diabetic ketoacidosis (DKA, a dangerous buildup of acids) at screening or study admission; or were hospitalized for DKA within the past year.
  • Have a history of slow stomach emptying, severe acid reflux, or inflammation of the pancreas; or a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that can cause tumors in hormone-making glands.
  • Have anemia (low red blood cells), with hemoglobin below 12 g/dL for women or below 13 g/dL for men.
  • Have high eosinophils, a type of white blood cell (above 500 cells per microliter), or low total white blood cells (below 4,000 cells per microliter).

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

Official eligibility criteria

Inclusion criteria: * History of type 1 diabetes, duration \> 5 years * Age 18-40 years * HbA1c \< 8.5% * BMI 19-34.9 kg/m2 * Using insulin for diabetes treatment only (multiple daily injections or insulin pump with or without sensor augmentation) * On stable regimen of non-diabetic medications for the last 6 months * All screening labs within normal limits or not clinically significant - English or Spanish speaking Exclusion criteria: * Pregnancy or currently breastfeeding * Smoking history within 6 months * History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) as well as clinically significant cardiac arrhythmias or conduction disorders * Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers). * Known hypersensitivity to perflutren (contained in Definity© contrast) * Screening O2 saturation \<90% * Musculoskeletal condition preventing participation in exercise testing or exercise training * Acute or unstable disease other than T1D * Hypoglycemia unawareness * History of gastroparesis, severe gastroesophageal reflux, pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 * Anemia (hemoglobin \<12 g/dL in women, hemoglobin \<13 g/dL in men), eosinophilia (absolute eosinophil count \>500 cells/microliter) leukopenia (total white blood cells \<4,000 cells/microliter) * Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days * Hospital admission for DKA within 1 year

Study sites (1)

FL