Recruiting
Phase 2

Therapeutic Strategies

Sponsor:

AdventHealth Translational Research Institute

Code:

NCT05478707

Conditions

Diabetes Mellitus, Type 1

Endothelial Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Dulaglutide

Placebo

Study Details

Brief summary:

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.

Conditions

Diabetes Mellitus, Type 1

Endothelial Dysfunction

Study ID

NCT05478707

Start date

Oct 5, 2023

Status verified date

Aug, 2026

Completion date

Jul 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

47 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Saline subcutaneous injection, volume matched to dulaglutide, i.e. 0.5 mL weekly for 14 weeks

active comparator: Dulaglutide

Dulaglutide (0.75 mg/0.5 mL weekly for 2 weeks, then 1.5 mg/0.5 mL weekly for 12 weeks) subcutaneous injection

Interventions

Dulaglutide

GLP1-RA

Placebo

Saline placebo

Primary outcome measure

  • Microvascular blood volume (MBV) [ Time Frame: At baseline and after 14 weeks of treatment. ]

Central Contacts and Locations

Central contacts

Recruitment Department, MD

407-303-7100CFD.TRI.Recruitment@AdventHealth.com

Locations

AdventHealth Translational Research Institute

Recruiting

Orlando, Florida, United States, 32804

Contacts

Recruitment Department

CFD.TRI.Recruitment@AdventHealth.com

Principal Investigator:

Kaitlin Love, MD

More Information

Sponsor

AdventHealth Translational Research Institute

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • microvessels
  • oxidative stress
  • Dulaglutide
  • Glucagon-like peptide-1
  • Exercise therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth Translational Research Institute on 2026-08-12.