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HomeTrials › NCT05478707

Type 2 diabetes · Phase 2 · Recruiting now

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

NCT05478707 · Sponsor: AdventHealth Translational Research Institute

What this trial means for you

This study is recruiting now at 1 US site. It's studying Dulaglutide, Placebo for diabetes mellitus, type 1, endothelial dysfunction.

Who can joinAll sexes, 18 Years – 40 Years
Healthy volunteersNo, diagnosis required
What you'd takeDulaglutide, Placebo
Study length~4.8 years overall
Planned participants47
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 by state

Florida

  • AdventHealth Translational Research Institute, Orlando · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently, so always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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