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Trial · Interventional

RecruitingPhase 2Registry data

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

Short name MCD-1

NCTNCT05478707 (opens ClinicalTrials.gov in a new tab)Other id2351846Other idK23DK131327
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
47 participants (estimated)
Sponsor
AdventHealth Translational Research Institute · Other
Design
Randomized · Triple masking
Countries
1 country

United States

Start
5 Oct 2023
Primary completion
30 Jun 2028 (estimated)
Completion
30 Jul 2028 (estimated)
First posted
28 Jul 2022
Last update posted
15 Oct 2026
Conditions
Diabetes Mellitus, Type 1 · Endothelial Dysfunction

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026202720282029
  1. Ph 2

    MCD-1

    NCT05478707

    5 Oct 2023 to est. 30 Jul 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • DulaglutideDrug
  • PlaceboDrug

Arms2

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Microvascular blood volume (MBV)

    Time frame · At baseline and after 14 weeks of treatment.

    Registry description

    Insulin mediated change in muscle microvascular blood volume (MBV). A measure of microvascular nitric oxide dependent endothelial function

Secondary outcomes(4)

  1. Brachial artery flow mediated dilation (FMD)

    Time frame · At baseline and after 14 weeks of treatment

    Registry description

    Post-occlusive percent (%) change in diameter. A measure of conduit artery nitric oxide-dependent endothelial function.

  2. Glucose infusion rate (GIR)

    Time frame · At baseline and after 14 weeks of treatment

    Registry description

    Mean GIR over the final 30 minutes of euglycemic insulin clamp; a measure of insulin sensitivity

  3. Cardiorespiratory fitness, maximum consumption of oxygen (VO2max)

    Time frame · At baseline and after 14 weeks of treatment

    Registry description

    Assessed by cycle ergometer exercise testing.

  4. Skeletal muscle oxygenation, deoxyhemoglobin (HHb)

    Time frame · At baseline and after 14 weeks of treatment. Measured before and after insulin clamp.

    Registry description

    Assessed by frequency domain multi-distance near-infrared spectroscopy (NIRS) monitor at the quadriceps muscle

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies11

Studies that cite this trial.

Studies with results

7 studies on this page

Indexing hint: Randomized controlled trial · 2019

3 results

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.

Gerstein et al. 2019Lancet (London, England)cited by 2,264

PMID 31189511DOI 10.1016/s0140-6736(19)31149-3PUB-31189511

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2018

9 results

Effects of 6-month treatment with the glucagon like peptide-1 analogue liraglutide on arterial stiffness, left ventricular myocardial deformation and oxidative stress in subjects with newly diagnosed type 2 diabetes.

Lambadiari et al. 2018Cardiovascular diabetologycited by 127

PMID 29310645PMC5759220DOI 10.1186/s12933-017-0646-zPUB-29310645

CC BY9 results
Download PDFSee results (9)

Indexing hint: Randomized controlled trial · 2016

8 results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,535

PMID 27295427PMC4985288DOI 10.1056/nejmoa1603827PUB-27295427

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Randomized controlled trial · 2016

10 results

Efficacy and Safety of Liraglutide Added to Capped Insulin Treatment in Subjects With Type 1 Diabetes: The ADJUNCT TWO Randomized Trial.

Ahrén et al. 2016Diabetes carecited by 212

PMID 27493132DOI 10.2337/dc16-0690PUB-27493132

Full text at the publisher10 results
Publisher pageSee results (10)

Indexing hint: Randomized controlled trial · 2016

14 results

Efficacy and Safety of Liraglutide Added to Insulin Treatment in Type 1 Diabetes: The ADJUNCT ONE Treat-To-Target Randomized Trial.

Mathieu et al. 2016Diabetes carecited by 270

PMID 27506222DOI 10.2337/dc16-0691PUB-27506222

Full text at the publisher14 results
Publisher pageSee results (14)

Indexing hint: Randomized controlled trial · 2016

8 results

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,002

PMID 27633186DOI 10.1056/nejmoa1607141PUB-27633186

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Clinical trial · 2013

1 result

Exenatide improves endothelial function assessed by flow mediated dilation technique in subjects with type 2 diabetes: results from an observational research.

Irace et al. 2013Diabetes & vascular disease researchcited by 57

PMID 22732108DOI 10.1177/1479164112449562PUB-22732108

Full text at the publisher1 result
Publisher pageSee results (1)

More studies

4 studies on this page

Indexing hint: Animal study · 2016

Liraglutide prevents microvascular insulin resistance and preserves muscle capillary density in high-fat diet-fed rats.

Chai et al. 2016American journal of physiology. Endocrinology and metabolismcited by 39

PMID 27436611PMC5142002DOI 10.1152/ajpendo.00205.2016PUB-27436611

Rights unknown
Source link

PubMed tag: none · 2015

GLP-1 receptor agonists in type 1 diabetes: a proof-of-concept approach.

Crisci et al. 2015Acta diabetologicacited by 12

PMID 26293127DOI 10.1007/s00592-015-0800-6PUB-26293127

Full text at the publisher
Publisher page

Indexing hint: In vitro study · 2014

Metformin and liraglutide ameliorate high glucose-induced oxidative stress via inhibition of PKC-NAD(P)H oxidase pathway in human aortic endothelial cells.

Batchuluun et al. 2014Atherosclerosiscited by 130

PMID 24401231DOI 10.1016/j.atherosclerosis.2013.10.025PUB-24401231

Full text at the publisher
Publisher page

Indexing hint: Randomized controlled trial · 2014

Corrected

Efficacy and safety of dulaglutide versus sitagliptin after 52 weeks in type 2 diabetes in a randomized controlled trial (AWARD-5).

Nauck et al. 2014Diabetes carecited by 227

PMID 24742660PMC4113177DOI 10.2337/dc13-2761PUB-24742660

Rights unknown
Source linkRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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