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The GLP-1-mediated Gut-kidney AxisGLP1RRBFNCT04337268

Acute Effects of GLP-1 on Renal Hemodynamics

A study testing Glucagon-Like Peptide 1 and saline 0.9% in people with The GLP-1-mediated Gut-kidney Axis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
The GLP-1-mediated Gut-kidney Axis
What is being tested?
Glucagon-Like Peptide 1 and saline 0.9%
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteDenmark
Study dates
1 Apr 2019to 1 Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

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 20 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • 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).
Show all 9Show fewer
  • Renal impairment (creatinine> 130 µM and / or albuminuria).
  • Severe claustrophobia.
  • MRI incompatible foreign bodies.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet - Glostrup

    Glostrup Municipality, Copenhagen, 2600

Other trials in Denmark

About this study

Official title: Acute Effects of GLP-1 on Renal Hemodynamics: Simultaneous Perfusion and Oxygenation Measurements in Cortex and Medulla Using Magnetic Resonance Imaging

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.

Read the detailed description

Human studies have recently demonstrated a significant natriuretic effect of GLP-1 when the extracellular fluid volume (ECFV) is expanded by intravenous sodium-loading; in these studies, there was a suppression of ANG II with no change in net renal hemodynamics, pointing to a tubular mechanism for reduced NaCl reabsorption secondary to the ANG II suppression. In the current randomized and controlled study, investigators aim to test 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. Thus, contributing to the renoprotective action of GLP-1.

Under fixed sodium intake for 4 days before each study day, 10 healthy male participants will be investigated during a 1-hour infusion of GLP-1 (1.5 pmol/kg/min) or vehicle together with an intravenous infusion of 0.9% NaCl. Interleaved measurements of RAF, oxygenation (T2*) and perfusion by arterial spin labeling in the renal cortex and medulla at fixed time points will be conducted, using Magnetic Resonance Imaging (MRI).

Being tested
Glucagon-Like Peptide 1, saline 0.9%
Keywords
glucagon-like peptide-1, kidney, renal hemodynamics, renal blood flow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glucagon-Like Peptide 1Drug

    Also called GLP-1

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

  • saline 0.9%Drug

    Also called Placebo for GLP-1

    Intravenous infusion for 60 min.

Study groups in NCT04337268
Study groupRoleWhat they receive
human glucagon-like peptide-1Active comparatorIntervention: Drug: human glucagon-like peptide-1 Other names: GLP-1
Receives: Drug: Glucagon-Like Peptide 1
PlaceboPlacebo comparatorIntervention: Drug: Placebo (saline) Other names: Placebo for human glucagon-like peptide-1
Receives: Drug: saline 0.9%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. T2* signal

    Changes in T2* signal in renal cortex and medulla

    Measured: 1 hour

  2. Arterial Spin Labeled (ASL)

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

    Measured: 1 hour

  3. Renal Artery Flow Phase (RAF)

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

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2020
  2. Study start1 Apr 2019
  3. Primary completion1 Mar 2020
  4. Study completion1 Mar 2020

Resources

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 N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Investigator
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04337268
Sponsor's protocol ID
H-18050603
Acronym
GLP1RRBF
Status last verified
Apr 2020
First submitted
29 Mar 2020
Last updated
7 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 17928588

  • 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.

    PubMed 17475961

  • 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.

    PubMed 24467746

  • 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.

    PubMed 25670826

  • 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.

    PubMed 26956188

  • 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.

    PubMed 28174344

  • 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.

    PubMed 23463656

  • 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.

    PubMed 30835273

  • 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.

    PubMed 36734354

Questions about this trial

What is this clinical trial studying?

A study testing Glucagon-Like Peptide 1 and saline 0.9% in people with The GLP-1-mediated Gut-kidney Axis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

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 2 inclusion and 9 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: finished, as of the sponsor's last update on 7 Apr 2020. 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 Denmark. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

T2* signal (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 NCT04337268, which also lists 9 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 7 Apr 2020.

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