NCT04337268

Brief Summary

This study investigates the hypothesis, that GLP-1's suppression of ANG II and natriuretic action increase medullary perfusion and decrease oxygen consumption, leading to higher tissue oxygenation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

11 months

First QC Date

March 29, 2020

Last Update Submit

April 3, 2020

Conditions

The GLP-1-mediated Gut-kidney Axis

Keywords

glucagon-like peptide-1kidneyrenal hemodynamicsrenal blood flow

Outcome Measures

Primary Outcomes (3)

  • T2* signal

    Changes in T2\* signal in renal cortex and medulla

    1 hour

  • Arterial Spin Labeled (ASL)

    Changes in Arterial Spin Labeled (ASL) MRI Perfusion Imaging in renal cortex and medulla

    1 hour

  • Renal Artery Flow Phase (RAF)

    Changes in Renal Artery Flow Phase (RAF)-Contrast Magnetic Resonance

    1 hour

Study Arms (2)

human glucagon-like peptide-1

ACTIVE COMPARATOR

Intervention: Drug: human glucagon-like peptide-1 Other names: GLP-1

Drug: Glucagon-Like Peptide 1

Placebo

PLACEBO COMPARATOR

Intervention: Drug: Placebo (saline) Other names: Placebo for human glucagon-like peptide-1

Drug: saline 0.9%

Interventions

Glucagon-Like Peptide 1DRUG

Intravenous infusion (1.5 pmol/kg/min) for 60 min.

Also known as: GLP-1
human glucagon-like peptide-1
saline 0.9%DRUG

Intravenous infusion for 60 min.

Also known as: Placebo for GLP-1
Placebo

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal health demonstrated by medical examination.
  • Normal values for fasting plasma glucose, total cholesterol, triglyceride, HDL, LDL, creatinine, AST, ALT and electrolyte concentrations.

You may not qualify if:

  • Immunosuppressive treatment for the previous 12 months.
  • Alcohol abuse.
  • Medical treatment with oral glucocorticoids, dipeptidyl peptidase-4 (DPP-4) inhibitors, or GLP-1 receptor agonists that, in the opinion of the investigator, may interfere with glucose metabolism.
  • Use of lithium.
  • Medical treatment that affects insulin secretion or cardiovascular efficacy goals.
  • Liver disease (ALT\> 2 x normal value).
  • Renal impairment (creatinine\> 130 µM and / or albuminuria).
  • Severe claustrophobia.
  • MRI incompatible foreign bodies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet - Glostrup

Glostrup Municipality, Copenhagen, 2600, Denmark

Location

Related Publications (9)

  • Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006.

    PMID: 17928588BACKGROUND

  • Korner M, Stockli M, Waser B, Reubi JC. GLP-1 receptor expression in human tumors and human normal tissues: potential for in vivo targeting. J Nucl Med. 2007 May;48(5):736-43. doi: 10.2967/jnumed.106.038679.

    PMID: 17475961BACKGROUND

  • Pyke C, Heller RS, Kirk RK, Orskov C, Reedtz-Runge S, Kaastrup P, Hvelplund A, Bardram L, Calatayud D, Knudsen LB. GLP-1 receptor localization in monkey and human tissue: novel distribution revealed with extensively validated monoclonal antibody. Endocrinology. 2014 Apr;155(4):1280-90. doi: 10.1210/en.2013-1934. Epub 2014 Jan 27.

    PMID: 24467746BACKGROUND

  • Asmar A, Simonsen L, Asmar M, Madsbad S, Holst JJ, Frandsen E, Moro C, Jonassen T, Bulow J. Renal extraction and acute effects of glucagon-like peptide-1 on central and renal hemodynamics in healthy men. Am J Physiol Endocrinol Metab. 2015 Apr 15;308(8):E641-9. doi: 10.1152/ajpendo.00429.2014. Epub 2015 Feb 10.

    PMID: 25670826BACKGROUND

  • Asmar A, Simonsen L, Asmar M, Madsbad S, Holst JJ, Frandsen E, Moro C, Sorensen CM, Jonassen T, Bulow J. Glucagon-like peptide-1 does not have acute effects on central or renal hemodynamics in patients with type 2 diabetes without nephropathy. Am J Physiol Endocrinol Metab. 2016 May 1;310(9):E744-53. doi: 10.1152/ajpendo.00518.2015. Epub 2016 Mar 8.

    PMID: 26956188BACKGROUND

  • Asmar A, Asmar M, Simonsen L, Madsbad S, Holst JJ, Hartmann B, Sorensen CM, Bulow J. Glucagon-like peptide-1 elicits vasodilation in adipose tissue and skeletal muscle in healthy men. Physiol Rep. 2017 Feb;5(3):e13073. doi: 10.14814/phy2.13073.

    PMID: 28174344BACKGROUND

  • Skov J, Dejgaard A, Frokiaer J, Holst JJ, Jonassen T, Rittig S, Christiansen JS. Glucagon-like peptide-1 (GLP-1): effect on kidney hemodynamics and renin-angiotensin-aldosterone system in healthy men. J Clin Endocrinol Metab. 2013 Apr;98(4):E664-71. doi: 10.1210/jc.2012-3855. Epub 2013 Mar 5.

    PMID: 23463656BACKGROUND

  • Asmar A, Cramon PK, Simonsen L, Asmar M, Sorensen CM, Madsbad S, Moro C, Hartmann B, Jensen BL, Holst JJ, Bulow J. Extracellular Fluid Volume Expansion Uncovers a Natriuretic Action of GLP-1: A Functional GLP-1-Renal Axis in Man. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2509-2519. doi: 10.1210/jc.2019-00004.

    PMID: 30835273BACKGROUND

  • Haddock B, Kristensen KB, Tayyab M, Larsson HBW, Lindberg U, Vestergaard M, Francis S, Jensen BL, Andersen UB, Asmar A. GLP-1 Promotes Cortical and Medullary Perfusion in the Human Kidney and Maintains Renal Oxygenation During NaCl Loading. J Am Heart Assoc. 2023 Feb 7;12(3):e027712. doi: 10.1161/JAHA.122.027712. Epub 2023 Feb 3.

    PMID: 36734354DERIVED

MeSH Terms

Interventions

Glucagon-Like Peptide 1Sodium Chloride

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ali Asmar, MD, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 29, 2020

First Posted

April 7, 2020

Study Start

April 1, 2019

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)