Diabetes Mellitus, Type 1Phase 2MCD-1NCT05478707
Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes
A Phase 2 study testing Dulaglutide in people with Diabetes Mellitus, Type 1 and Endothelial Dysfunction, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Endothelial Dysfunction
- What is being tested?
- Dulaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 30 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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%
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth Translational Research Institute
Orlando, Florida, 32804
Recruitment Department, CFD.TRI.Recruitment@AdventHealth.com
Kaitlin Love, MD
About this study
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.
Read the detailed description
In this study, 47 (n=32 needed to complete) adult participants with type 1 diabetes will be randomized (1:1) to 14-weeks of one of 2 interventions: 1) dulaglutide, 2) placebo.
Participants will undergo two study admissions at baseline and 14 weeks. Prior to each admission, participants will wear a continuous glucose monitor (Dexcom G6 Professional) for 10 days to assess glycemic variability (GV). Prior to admissions, they will undergo cardiorespiratory fitness testing. On study admission days, participants will undergo an antecubital vein endothelial cell biopsy prior to commencing vascular testing. From the harvested endothelial cells, the investigators will quantify endothelial cell reactive oxygen species (ROS) and gene expression relevant to insulin-mediated endothelial function. Vascular testing will include contrast enhanced ultrasound of quadriceps muscle to determine microvascular blood volume (MBV). The investigators will also measure brachial artery flow mediated dilation (FMD). Quadriceps skeletal muscle oxygenation (HHb) will also be measured. These vascular and muscle oxygenation measurements will be conducted before and after a 120-minute euglycemic insulin clamp which will measure insulin sensitivity based on glucose infusion rate (GIR).
This randomized, placebo-controlled study will assess whether GLP-1 receptor agonism with dulaglutide or exercise training improves insulin-mediated skeletal muscle microvascular perfusion. The investigators will assess for predictive relationships between microvascular perfusion and cardiorespiratory fitness (VO2max), insulin sensitivity (GIR), endothelial reactive oxygen species (ROS), and glycemic variability (GV).
- Conditions
- Diabetes Mellitus, Type 1, Endothelial Dysfunction
- Being tested
- Dulaglutide, Placebo
- Keywords
- microvessels, oxidative stress, Dulaglutide, Glucagon-like peptide-1, Exercise therapy
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DulaglutideDrug
GLP1-RA
PlaceboDrug
Saline placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Saline subcutaneous injection, volume matched to dulaglutide, i.e. 0.5 mL weekly for 14 weeks Receives: Drug: Placebo |
| Dulaglutide | Active comparator | Dulaglutide (0.75 mg/0.5 mL weekly for 2 weeks, then 1.5 mg/0.5 mL weekly for 12 weeks) subcutaneous injection Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular blood volume (MBV)
Insulin mediated change in muscle microvascular blood volume (MBV). A measure of microvascular nitric oxide dependent endothelial function
Measured: At baseline and after 14 weeks of treatment.
Secondary outcomes (4)
Brachial artery flow mediated dilation (FMD)
Post-occlusive percent (%) change in diameter. A measure of conduit artery nitric oxide-dependent endothelial function.
Measured: At baseline and after 14 weeks of treatment
Glucose infusion rate (GIR)
Mean GIR over the final 30 minutes of euglycemic insulin clamp; a measure of insulin sensitivity
Measured: At baseline and after 14 weeks of treatment
Cardiorespiratory fitness, maximum consumption of oxygen (VO2max)
Assessed by cycle ergometer exercise testing.
Measured: At baseline and after 14 weeks of treatment
Skeletal muscle oxygenation, deoxyhemoglobin (HHb)
Assessed by frequency domain multi-distance near-infrared spectroscopy (NIRS) monitor at the quadriceps muscle
Measured: At baseline and after 14 weeks of treatment. Measured before and after insulin clamp.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start5 Oct 2023
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaitlin Love, AdventHealth Translational Research Institute
- Investigators
- Kaitlin Love, MD, Principal investigator, Site Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478707
- Sponsor's protocol ID
- 2351846
- Other IDs
- K23DK131327
- Acronym
- MCD-1
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Secrest AM, Becker DJ, Kelsey SF, Laporte RE, Orchard TJ. Cause-specific mortality trends in a large population-based cohort with long-standing childhood-onset type 1 diabetes. Diabetes. 2010 Dec;59(12):3216-22. doi: 10.2337/db10-0862. Epub 2010 Aug 25.
PubMed 20739685Rawshani A, Sattar N, Franzen S, Rawshani A, Hattersley AT, Svensson AM, Eliasson B, Gudbjornsdottir S. Excess mortality and cardiovascular disease in young adults with type 1 diabetes in relation to age at onset: a nationwide, register-based cohort study. Lancet. 2018 Aug 11;392(10146):477-486. doi: 10.1016/S0140-6736(18)31506-X. Epub 2018 Aug 9.
PubMed 30129464Foster NC, Beck RW, Miller KM, Clements MA, Rickels MR, DiMeglio LA, Maahs DM, Tamborlane WV, Bergenstal R, Smith E, Olson BA, Garg SK. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther. 2019 Feb;21(2):66-72. doi: 10.1089/dia.2018.0384. Epub 2019 Jan 18.
PubMed 30657336Bergman BC, Howard D, Schauer IE, Maahs DM, Snell-Bergeon JK, Eckel RH, Perreault L, Rewers M. Features of hepatic and skeletal muscle insulin resistance unique to type 1 diabetes. J Clin Endocrinol Metab. 2012 May;97(5):1663-72. doi: 10.1210/jc.2011-3172. Epub 2012 Feb 22.
PubMed 22362823Donga E, Dekkers OM, Corssmit EP, Romijn JA. Insulin resistance in patients with type 1 diabetes assessed by glucose clamp studies: systematic review and meta-analysis. Eur J Endocrinol. 2015 Jul;173(1):101-9. doi: 10.1530/EJE-14-0911. Epub 2015 Apr 21.
PubMed 25899581Bjornstad P, Maahs DM, Duca LM, Pyle L, Rewers M, Johnson RJ, Snell-Bergeon JK. Estimated insulin sensitivity predicts incident micro- and macrovascular complications in adults with type 1 diabetes over 6 years: the coronary artery calcification in type 1 diabetes study. J Diabetes Complications. 2016 May-Jun;30(4):586-90. doi: 10.1016/j.jdiacomp.2016.02.011. Epub 2016 Feb 11.
PubMed 26936306Barrett EJ, Wang H, Upchurch CT, Liu Z. Insulin regulates its own delivery to skeletal muscle by feed-forward actions on the vasculature. Am J Physiol Endocrinol Metab. 2011 Aug;301(2):E252-63. doi: 10.1152/ajpendo.00186.2011. Epub 2011 May 24.
PubMed 21610226Muniyappa R, Chen H, Montagnani M, Sherman A, Quon MJ. Endothelial dysfunction due to selective insulin resistance in vascular endothelium: insights from mechanistic modeling. Am J Physiol Endocrinol Metab. 2020 Sep 1;319(3):E629-E646. doi: 10.1152/ajpendo.00247.2020. Epub 2020 Aug 10.
PubMed 32776829Ce GV, Rohde LE, da Silva AM, Punales MK, de Castro AC, Bertoluci MC. Endothelial dysfunction is related to poor glycemic control in adolescents with type 1 diabetes under 5 years of disease: evidence of metabolic memory. J Clin Endocrinol Metab. 2011 May;96(5):1493-9. doi: 10.1210/jc.2010-2363. Epub 2011 Feb 23.
PubMed 21346068Inaba Y, Chen JA, Bergmann SR. Prediction of future cardiovascular outcomes by flow-mediated vasodilatation of brachial artery: a meta-analysis. Int J Cardiovasc Imaging. 2010 Aug;26(6):631-40. doi: 10.1007/s10554-010-9616-1. Epub 2010 Mar 26.
PubMed 20339920Zhao L, Fu Z, Wu J, Aylor KW, Barrett EJ, Cao W, Liu Z. Inflammation-induced microvascular insulin resistance is an early event in diet-induced obesity. Clin Sci (Lond). 2015 Dec;129(12):1025-36. doi: 10.1042/CS20150143. Epub 2015 Aug 11.
PubMed 26265791Love KM, Jahn LA, Hartline LM, Patrie JT, Barrett EJ, Liu Z. Insulin-mediated muscle microvascular perfusion and its phenotypic predictors in humans. Sci Rep. 2021 Jun 1;11(1):11433. doi: 10.1038/s41598-021-90935-8.
PubMed 34075130Ceriello A, Novials A, Ortega E, Canivell S, La Sala L, Pujadas G, Bucciarelli L, Rondinelli M, Genovese S. Vitamin C further improves the protective effect of glucagon-like peptide-1 on acute hypoglycemia-induced oxidative stress, inflammation, and endothelial dysfunction in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4104-8. doi: 10.2337/dc13-0750. Epub 2013 Oct 15.
PubMed 24130351Ceriello A, Novials A, Ortega E, Canivell S, La Sala L, Pujadas G, Esposito K, Giugliano D, Genovese S. Glucagon-like peptide 1 reduces endothelial dysfunction, inflammation, and oxidative stress induced by both hyperglycemia and hypoglycemia in type 1 diabetes. Diabetes Care. 2013 Aug;36(8):2346-50. doi: 10.2337/dc12-2469. Epub 2013 Apr 5.
PubMed 23564922Papachristoforou E, Lambadiari V, Maratou E, Makrilakis K. Association of Glycemic Indices (Hyperglycemia, Glucose Variability, and Hypoglycemia) with Oxidative Stress and Diabetic Complications. J Diabetes Res. 2020 Oct 12;2020:7489795. doi: 10.1155/2020/7489795. eCollection 2020.
PubMed 33123598
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05478707
- Acronym / sponsor ID
- MCD-1 / 2351846
- Conditions
- Diabetes Mellitus, Type 1, Endothelial Dysfunction
- Keywords
- microvessels, oxidative stress, Dulaglutide, Glucagon-like peptide-1, Exercise therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 28 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this study, 47 (n=32 needed to complete) adult participants with type 1 diabetes will be randomized (1:1) to 14-weeks of one of 2 interventions: 1) dulaglutide, 2) placebo.
Participants will undergo two study admissions at baseline and 14 weeks. Prior to each admission, participants will wear a continuous glucose monitor (Dexcom G6 Professional) for 10 days to assess glycemic variability (GV). Prior to admissions, they will undergo cardiorespiratory fitness testing. On study admission days, participants will undergo an antecubital vein endothelial cell biopsy prior to commencing vascular testing. From the harvested endothelial cells, the investigators will quantify endothelial cell reactive oxygen species (ROS) and gene expression relevant to insulin-mediated endothelial function. Vascular testing will include contrast enhanced ultrasound of quadriceps muscle to determine microvascular blood volume (MBV). The investigators will also measure brachial artery flow mediated dilation (FMD). Quadriceps skeletal muscle oxygenation (HHb) will also be measured. These vascular and muscle oxygenation measurements will be conducted before and after a 120-minute euglycemic insulin clamp which will measure insulin sensitivity based on glucose infusion rate (GIR).
This randomized, placebo-controlled study will assess whether GLP-1 receptor agonism with dulaglutide or exercise training improves insulin-mediated skeletal muscle microvascular perfusion. The investigators will assess for predictive relationships between microvascular perfusion and cardiorespiratory fitness (VO2max), insulin sensitivity (GIR), endothelial reactive oxygen species (ROS), and glycemic variability (GV).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSaline subcutaneous injection, volume matched to dulaglutide, i.e. 0.5 mL weekly for 14 weeks |
| Dulaglutide | Active comparator | Drug: DulaglutideDulaglutide (0.75 mg/0.5 mL weekly for 2 weeks, then 1.5 mg/0.5 mL weekly for 12 weeks) subcutaneous injection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DulaglutideGLP1-RA | Drug | Dulaglutide |
| PlaceboSaline placebo | Drug | Placebo |
Primary outcome
Microvascular blood volume (MBV)
Time frame: At baseline and after 14 weeks of treatment.
Insulin mediated change in muscle microvascular blood volume (MBV). A measure of microvascular nitric oxide dependent endothelial function
4 secondary outcomes
Brachial artery flow mediated dilation (FMD)
Time frame: At baseline and after 14 weeks of treatment
Glucose infusion rate (GIR)
Time frame: At baseline and after 14 weeks of treatment
Cardiorespiratory fitness, maximum consumption of oxygen (VO2max)
Time frame: At baseline and after 14 weeks of treatment
Skeletal muscle oxygenation, deoxyhemoglobin (HHb)
Time frame: At baseline and after 14 weeks of treatment. Measured before and after insulin clamp.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 20739685Secrest AM, Becker DJ, Kelsey SF, Laporte RE, Orchard TJ. Cause-specific mortality trends in a large population-based cohort with long-standing childhood-onset type 1 diabetes. Diabetes. 2010 Dec;59(12):3216-22. doi: 10.2337/db10-0862. Epub 2010 Aug 25.
- Background: PubMed 30129464Rawshani A, Sattar N, Franzen S, Rawshani A, Hattersley AT, Svensson AM, Eliasson B, Gudbjornsdottir S. Excess mortality and cardiovascular disease in young adults with type 1 diabetes in relation to age at onset: a nationwide, register-based cohort study. Lancet. 2018 Aug 11;392(10146):477-486. doi: 10.1016/S0140-6736(18)31506-X. Epub 2018 Aug 9.
- Background: PubMed 30657336Foster NC, Beck RW, Miller KM, Clements MA, Rickels MR, DiMeglio LA, Maahs DM, Tamborlane WV, Bergenstal R, Smith E, Olson BA, Garg SK. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technol Ther. 2019 Feb;21(2):66-72. doi: 10.1089/dia.2018.0384. Epub 2019 Jan 18.
- Background: PubMed 22362823Bergman BC, Howard D, Schauer IE, Maahs DM, Snell-Bergeon JK, Eckel RH, Perreault L, Rewers M. Features of hepatic and skeletal muscle insulin resistance unique to type 1 diabetes. J Clin Endocrinol Metab. 2012 May;97(5):1663-72. doi: 10.1210/jc.2011-3172. Epub 2012 Feb 22.
- Background: PubMed 25899581Donga E, Dekkers OM, Corssmit EP, Romijn JA. Insulin resistance in patients with type 1 diabetes assessed by glucose clamp studies: systematic review and meta-analysis. Eur J Endocrinol. 2015 Jul;173(1):101-9. doi: 10.1530/EJE-14-0911. Epub 2015 Apr 21.
- Background: PubMed 26936306Bjornstad P, Maahs DM, Duca LM, Pyle L, Rewers M, Johnson RJ, Snell-Bergeon JK. Estimated insulin sensitivity predicts incident micro- and macrovascular complications in adults with type 1 diabetes over 6 years: the coronary artery calcification in type 1 diabetes study. J Diabetes Complications. 2016 May-Jun;30(4):586-90. doi: 10.1016/j.jdiacomp.2016.02.011. Epub 2016 Feb 11.
- Background: PubMed 21610226Barrett EJ, Wang H, Upchurch CT, Liu Z. Insulin regulates its own delivery to skeletal muscle by feed-forward actions on the vasculature. Am J Physiol Endocrinol Metab. 2011 Aug;301(2):E252-63. doi: 10.1152/ajpendo.00186.2011. Epub 2011 May 24.
- Background: PubMed 32776829Muniyappa R, Chen H, Montagnani M, Sherman A, Quon MJ. Endothelial dysfunction due to selective insulin resistance in vascular endothelium: insights from mechanistic modeling. Am J Physiol Endocrinol Metab. 2020 Sep 1;319(3):E629-E646. doi: 10.1152/ajpendo.00247.2020. Epub 2020 Aug 10.
- Background: PubMed 21346068Ce GV, Rohde LE, da Silva AM, Punales MK, de Castro AC, Bertoluci MC. Endothelial dysfunction is related to poor glycemic control in adolescents with type 1 diabetes under 5 years of disease: evidence of metabolic memory. J Clin Endocrinol Metab. 2011 May;96(5):1493-9. doi: 10.1210/jc.2010-2363. Epub 2011 Feb 23.
- Background: PubMed 20339920Inaba Y, Chen JA, Bergmann SR. Prediction of future cardiovascular outcomes by flow-mediated vasodilatation of brachial artery: a meta-analysis. Int J Cardiovasc Imaging. 2010 Aug;26(6):631-40. doi: 10.1007/s10554-010-9616-1. Epub 2010 Mar 26.
- Background: PubMed 26265791Zhao L, Fu Z, Wu J, Aylor KW, Barrett EJ, Cao W, Liu Z. Inflammation-induced microvascular insulin resistance is an early event in diet-induced obesity. Clin Sci (Lond). 2015 Dec;129(12):1025-36. doi: 10.1042/CS20150143. Epub 2015 Aug 11.
- Background: PubMed 34075130Love KM, Jahn LA, Hartline LM, Patrie JT, Barrett EJ, Liu Z. Insulin-mediated muscle microvascular perfusion and its phenotypic predictors in humans. Sci Rep. 2021 Jun 1;11(1):11433. doi: 10.1038/s41598-021-90935-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaitlin Love, MD principal investigator
Site Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dulaglutide in people with Diabetes Mellitus, Type 1 and Endothelial Dysfunction, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Recruitment Department, MD (407-303-7100, CFD.TRI.Recruitment@AdventHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular blood volume (MBV) (time frame: At baseline and after 14 weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05478707, which also lists 58 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.