The Role of Endogenous GIP in Glycosis Metabolism During Fasting

Obesity Clinical Trial

Official title:

GA-18: The Role of Endogenous GIP in Glycosis Metabolism During Fasting

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06368752
• Other study ID #: H-22063621
• Status: Enrolling by invitation
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Obesity

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