Improving blood flow in type 1 diabetes with medication and exercise

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of glucagon-like peptide-1 receptor agonism (GLP-1RA) using dulaglutide and exercise training on microvascular function in adults with type 1 diabetes. A total of 64 participants will be randomized into three groups: one receiving dulaglutide, one receiving a placebo, and one undergoing exercise training over a 14-week period. The study will assess changes in insulin-mediated skeletal muscle microvascular perfusion and endothelial function through various vascular tests and measurements of oxidative stress. Participants will also wear continuous glucose monitors to evaluate glycemic variability throughout the study.

Why it matters

Who can join: the full rules

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

Where it's running

• AdventHealth Translational Research Institute
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: Kaitlin Love, MD — Site Principal Investigator
• Study coordinator: Recruitment Department, MD
• Email: CFD.TRI.Recruitment@AdventHealth.com
• Phone: 407-303-7100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.