Improving blood flow in type 1 diabetes with medication and exercise
Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes
This study is testing whether a combination of a medication called dulaglutide and exercise can improve blood flow in adults with type 1 diabetes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05478707 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-40 with a history of type 1 diabetes for more than 5 years and controlled HbA1c levels.
Not a fit: Patients with significant diabetes-related complications or those on vasoactive medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for enhancing blood flow and reducing complications in patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with GLP-1 receptor agonists in improving vascular function, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 * C-peptide \<0.6 ng/ml 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 (based on Clarke's questionnaire) * 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 this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Kaitlin Love, MD — Associate Professor - Endocrinology
- Study coordinator: Kaitlin Love, MD
- Email: KML2W@hscmail.mcc.virginia.edu
- Phone: 434-924-9651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.