NCT06208904

Brief Summary

The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

First Submitted

Initial submission to the registry

January 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1.6 years

First QC Date

January 5, 2024

Last Update Submit

March 11, 2025

Conditions

PostPrandial Hypotension

Keywords

Postprandial hypotensionGlucose-dependent insulinotropic polypeptideGIPGIP receptor antagonistGIP(3-30)NH2

Outcome Measures

Primary Outcomes (2)

  • Nadir systolic blood pressure (SBP) (mmHg)

    Baseline

    -45-0 minutes

  • Nadir systolic blood pressure (mmHg)

    Nadir and time to nadir

    0-180 minutes

Secondary Outcomes (11)

  • Occurrence of PPH

    0-180 minutes

  • Systolic blood pressure (mmHg)

    -45-0 minutes

  • Systolic blood pressure (mmHg)

    0-180 minutes

  • Diastolic blood pressure (mmHg)

    -45-0 minutes

  • Diastolic blood pressure (mmHg)

    0-180 minutes

  • +6 more secondary outcomes

Other Outcomes (6)

  • Plasma glucose

    -45-0 minutes

  • Plasma glucose

    0-180 minutes

  • Gastric emptying rate

    -45-0 minutes

  • +3 more other outcomes

Study Arms (2)

GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist)

EXPERIMENTAL

Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min

Other: Intravenous infusion of GIPRA

Saline

PLACEBO COMPARATOR

Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin

Other: Intravenous infusion of saline

Interventions

Intravenous infusion of GIPRAOTHER

Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min during experimental days

Also known as: GIP(3-30)NH2
GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist)
Intravenous infusion of salineOTHER

Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin during experimental days

Also known as: Placebo (Saline)
Saline

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-85 years
  • History of PPH-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion
  • Informed consent

You may not qualify if:

  • Not fulfilling the PPH diagnosis during the mixed meal test or during the test meal with increased (+25%) number of calories
  • Treatment with antihypertensives
  • Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within three months before screening visit
  • Allergy or intolerance to ingredients included in the mixed meal
  • Any ongoing medication that the investigator evaluates would interfere with trial participation
  • Any physical or psychological condition that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
  • Anaemia (haemoglobin below normal range \<7.3 mmol/L for women and \<8.3 mmol/L for men)
  • Moderate to severe loss of kidney function (estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73 m2) at screening
  • Known liver disease (except for simple steatosis) and/or elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal at screening
  • Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardize the participant's safety during the trial
  • Alcohol/drug abuse as per discretion of the investigators
  • Pregnancy or breastfeeding
  • Participation in any other clinical trial during study period
  • Mental incapacity or language barriers that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements or pr discretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Metabolic Research

Copenhagen, Hellerup, 2900, Denmark

Location

MeSH Terms

Interventions

gastric inhibitory polypeptide (3-30)-amideSodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Lise Wilki-Kurtzhals

    University Hospital, Gentofte, Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor and PhD student

Study Record Dates

First Submitted

January 5, 2024

First Posted

January 17, 2024

Study Start

May 15, 2024

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

DK(1)