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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06368752
Other study ID # H-22063621
Secondary ID
Status Enrolling by invitation
Phase Early Phase 1
First received
Last updated
Start date May 4, 2023
Est. completion date December 31, 2025

Study information

Verified date April 2024
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP[3-30]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion.


Description:

This research project investigates the effects endogenous GIP has in the body of healthy, overweight people. Two trial days will be held. The participant will receive intravenous infusion of either GIP[3-30]NH2 (800 pmol/kg/min) or placebo (saline) in a randomized order. After 20 minutes, GIP[3-30]NH2 is expected to have maximum effect. On time of 180 minutes, an ad libitum meal is served, which is consumed during continued infusion. When the participant is comfortably full, the infusion is turned off and the trial day ends. During the day, the participant assesses and notes on standardized VAS schedules current appetite, satiety, nausea, fatigue, malaise and thirst. Blood pressure and heart rate are measured every 30 minutes throughout the trial day and blood samples are taken. In total, there will be drawn ten blood samples between intervals of 15 to 30 min. Three times along the way, the activity in the brown adipose tissue is measured with a thermal camera (temperature measurements over the skin on the chest) and the resting metabolic rate is determined with indirect calorimetry (inhaled and exhaled air is captured by breathing under a large plastic bell).


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 12
Est. completion date December 31, 2025
Est. primary completion date December 12, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 18-70 years - BMI > 30 kg/m2 - Body fat percentage > 25 % for men og > 35 % for women Exclusion Criteria: - Type 1 diabetes and/or type 2 diabetes diagnosis - Other chronic condition - Treatment with medications or supplements that cannot be paused for 12 hours - > 14 units of alcohol weekly or drug abuse - Circulating liver enzymes (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT)) = 2 × normal value - Renal impairment (eGFR < 90 or creatinine level above the reference range) - Uncontrolled high resting blood pressure (above 140/90 mmHg) - Low blood percentage (hemoglobin < reference range (different for women and men)) - Special diet or planned weight change within the trial period - Any disease/condition that investigators believe will interfere with study participation

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
GIP[3-30]NH2
GIP[3-30]NH2 is the naturally occurring shorter (truncated) variant of GIP[1-42]. GIP[3-30]NH2 also stimulates the GIP receptor and therefore acts like a GIP receptorantagonist
Other:
Saline
Sodium chlorid with 0,5% human serum albumin.

Locations

Country Name City State
Denmark Gentofte Hospital Hellerup

Sponsors (1)

Lead Sponsor Collaborator
Frederikke Koefoed-Hansen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma glucagon concentrations Measured in mmol/L. The primary endpoint is plasma glucagon concentrations during GIP[3-30]NH2 infusion compared to placebo.Area under the curve (AUC) for plasma glucagon (AUCglucagon) is quantified both as absolute and in baseline-subtracted values (bsAUCglucagon) and the effect of the GIP receptor antagonist will be calculated as a percentage reduction of bsAUC glucagon relative to bsAUC glucagon during the placebo infusion. Four hours
Secondary Plasma levels of C-peptide Measured in mmol/L Four hours
Secondary Plasma levels of insulin Measured in mmol/L Four hours
Secondary Resting metabolic rate Measured in resting energy expenditure (REE) and respiratory quotient (RQ) 15 minutes
Secondary Activity in brown adipose tissue Measured by thermal camera 10 minutes
Secondary Appetite Measured in kilogram food intake 30 minutes
Secondary Blood pressure mmHg Pre-intervention at time -30 and -20 min. During infusion at time 0 min, 30 min, 60 min, 90 min, 120 min, 160 min and 180 min.
Secondary Puls Beats pr. minutes Pre-intervention at time -30 and -20 minutes. During infusion at time 0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 160 minutes, and 180 minutes
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