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Trial · Interventional

WithdrawnEarly phase 1Registry data

Effect of GLP-1 on Microvascular Insulin Responses in Type 1 Diabetes

Short name KML001

NCTNCT04133922 (opens ClinicalTrials.gov in a new tab)Other id21590Other id5R01DK102359-03
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glucagon, does not test it. It appears in the description.

Overview

Status
Withdrawn
Phase
Early phase 1
Enrollment
0 participants (actual)
Sponsor
University of Virginia · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
14 Oct 2019
Primary completion
Oct 2023 (estimated)
Completion
Oct 2024 (estimated)
First posted
21 Oct 2019
Last update posted
22 Mar 2022
Conditions
Type 1 Diabetes · Insulin Sensitivity/Resistance

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022202320242025
  1. Ph Early 1

    KML001

    NCT04133922

    14 Oct 2019 to est. Oct 2024

    Withdrawn

Registry summary

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

GLP-1 increases skeletal and cardiac microvascular perfusion and improves insulin's microvascular responses in human subjects with T1DM, leading to improved metabolic insulin responses, endothelial function, and increased muscle oxygenation

Interventions

  • GLP-1Drug
  • InsulinDrug
  • Dextrose 20 % in WaterDrug

Arms3

  • Active comparator

    GLP-1

    GLP-1 infusion 1.2 pmol/kg/min for 150 min

  • Active comparator

    GLP-1 + Insulin clamp

    GLP-1 infusion 1.2 pmol/kg/min for 150 min and insulin 1 mU/kg/min + Dextrose 20% at variable rate to maintain euglycemia for 120 min

  • Active comparator

    Saline + Insulin clamp

    Saline infusion at 30 ml/hr for 150 min and insulin 1 mU/kg/min + Dextrose 20% at variable rate to maintain euglycemia for 120 min.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. change in microvascular blood volume between baseline and 2 hour insulin clamp

    Time frame · baseline and after 2 hour insulin clamp

    Registry description

    vascular measurement

  2. change in insulin sensitivity between baseline and 2 hour insulin clamp

    Time frame · baseline and after 2 hour insulin clamp

    Registry description

    vascular measurement

Secondary outcomes(3)

  1. change in augmentation index between baseline and 2 hour insulin clamp

    Time frame · baseline and after 2 hour insulin clamp

    Registry description

    vascular measurement

  2. change in flow-mediated dilation between baseline and 2 hour insulin clamp

    Time frame · baseline and after 2 hour insulin clamp

    Registry description

    vascular measurement

  3. change in pulse wave velocity between baseline and 2 hour insulin clamp

    Time frame · baseline and after 2 hour insulin clamp

    Registry description

    vascular measurement

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

Studies6

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Meta-analysis (pooled) · 2017

Treatment with GLP1 receptor agonists reduce serum CRP concentrations in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials.

Mazidi et al. 2017Journal of diabetes and its complicationscited by 67

PMID 28479155DOI 10.1016/j.jdiacomp.2016.05.022PUB-28479155

Full text at the publisher
Publisher page

PubMed tag: none · 2017

7 results

Anti-inflammatory Effect of Glucagon Like Peptide-1 Receptor Agonist, Exendin-4, through Modulation of IB1/JIP1 Expression and JNK Signaling in Stroke.

Kim et al. 2017Experimental neurobiologycited by 49

PMID 28912645PMC5597553DOI 10.5607/en.2017.26.4.227PUB-28912645

Free to read · publisher termsCC BY-NC7 results
Read at sourceSee results (7)

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: Clinical trial · 2005

3 results

Adjunctive therapy with pramlintide lowers HbA1c without concomitant weight gain and increased risk of severe hypoglycemia in patients with type 1 diabetes approaching glycemic targets.

Ratner et al. 2005Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Associationcited by 41

PMID 15891954DOI 10.1055/s-2005-837662PUB-15891954

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

More studies

2 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

Indexing hint: In vitro study · 2013

Glucagon-like peptide-1 receptor agonist liraglutide inhibits endothelin-1 in endothelial cell by repressing nuclear factor-kappa B activation.

Dai et al. 2013Cardiovascular drugs and therapycited by 91

PMID 23657563DOI 10.1007/s10557-013-6463-zPUB-23657563

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 40 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. History of type 1 diabetes, duration \> 1 year 2. Age 18-40 years 3. HbA1c \< 8.5% 4. BMI \>/=18, \<30 kg/m2 5. Using insulin for diabetes treatment only 6. On stable regimen of non-diabetic medications for the last 6 months, excluding oral contraceptives (OCP) 7. All screening labs within normal limits or not clinical significant Exclusion Criteria: 1\) Pregnancy or currently breastfeeding 2) Smoking history within 6 months 3) History of microvascular (microalbuminuria, retinopathy, neuropathy) or macrovascular diabetes complications (coronary artery disease, stroke, peripheral vascular disease) 4) Taking vasoactive medications (i.e. calcium channel blockers, angiotensin-converting enzyme or renin inhibitors, angiotensin-receptor blockers, nitrates, alpha-blockers) 5) OCP use within 3 months or 1 month if menses has subsequently occurred 6) Known hypersensitivity to perflutren (contained in Definity© contrast) 7) Screening O2 saturation\<90% 8) Anemia (hemoglobin \<12 g/dL in women, hemoglobin \<13 g/dL in men) 9) Diabetic ketoacidosis (DKA) on presentation to screening visits or study admission days \-

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