NCT05478707RecruitingPhase 2
Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (estimated)
- First submitted
- 25 Jul 2022
- Start date
- 5 Oct 2023
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- AdventHealth Translational Research Institute
- Diseases
- Type 1 diabetes
- NCT number
- NCT05478707
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 47
- From 5 Oct 2023 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Known hypersensitivity to perflutren (contained in Definity© contrast)
- Musculoskeletal condition preventing participation in exercise testing or exercise training
- Acute or unstable disease other than T1D
- History of gastroparesis, severe gastroesophageal reflux, pancreatitis, personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
Lab values
- Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers).
- 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)
Other
- Pregnancy or currently breastfeeding
- Smoking history within 6 months
- Screening O2 saturation \<90%
- Hypoglycemia unawareness
- Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days
- Hospital admission for DKA within 1 year
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AdventHealth Translational Research Institute Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.