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Enrolling by Invitation

NCT Number: NCT06208904

The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension

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

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research

Copenhagen, Hellerup, 2900, Denmark

About this study

The study is an exploratory, randomised, placebo-controlled, double-blind crossover study comprising two experimental days with an infusion of the GIP receptor antagonist, GIP(3-30)NH2 (NH2 is the aminogroup), and placebo (saline) during a 180-minute mixed meal test (MMT). Eighteen participants, men and women, with MMT confirmed PPH will be included in the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Intravenous infusion of GIPRA

Other

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

Other names: GIP(3-30)NH2

Intravenous infusion of saline

Other

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

Other names: Placebo (Saline)

Primary outcomes

  1. Nadir systolic blood pressure (SBP) (mmHg)

    Time frame: -45-0 minutes

    Baseline

  2. Nadir systolic blood pressure (mmHg)

    Time frame: 0-180 minutes

    Nadir and time to nadir

Secondary outcomes

  1. Occurrence of PPH

    Time frame: 0-180 minutes

    (Yes/No) PPH is defined as either a drop in SBP >20 mmHg from baseline or SBP <90 mmHg

  2. Systolic blood pressure (mmHg)

    Time frame: -45-0 minutes

    Baseline

  3. Systolic blood pressure (mmHg)

    Time frame: 0-180 minutes

    Peak, nadir and iAUC (incremental area under the curve)

  4. Diastolic blood pressure (mmHg)

    Time frame: -45-0 minutes

    Baseline

  5. Diastolic blood pressure (mmHg)

    Time frame: 0-180 minutes

    Peak, nadir and iAUC

  6. Heart rate (beats/min)

    Time frame: -45-0 minutes

    Baseline

  7. Heart rate (beats/min)

    Time frame: 0-180 minutes

    Peak, nadir and iAUC

  8. Stroke volumen (ml)

    Time frame: -45-0 minutes

    Baseline

  9. Stroke volumen (ml)

    Time frame: 0-180 minutes

    Peak, nadir and iAUC

  10. Cardiac output (l/min)

    Time frame: -45-0 minutes

    Baseline

  11. Cardiac output (l/min)

    Time frame: 0-180 minutes

    Peak, nadir and iAUC

Other outcomes

  1. Plasma glucose

    Time frame: -45-0 minutes

    Baseline

  2. Plasma glucose

    Time frame: 0-180 minutes

    Peak, nadir and iAUC

  3. Gastric emptying rate

    Time frame: -45-0 minutes

    Plasma acetaminophen, baseline

  4. Gastric emptying rate

    Time frame: 0-180 minutes

    Plasma acetaminophen, peak and time to peak

  5. Plasma GIP(3-30)NH2

    Time frame: -45-0 minutes

    Baseline

  6. Plasma GIP(3-30)NH2

    Time frame: 0-180 minutes

    Peak and iAUC

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: GA-21

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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