The Role of Endogenous GIP in Glycosis Metabolism During Fasting

Frederikke Koefoed-Hansen

Status and phase

Invitation-only

Early Phase 1

Conditions

Obesity

Treatments

Other: Saline

Biological: GIP[3-30]NH2

Study type

Interventional

Funder types

Other

Identifiers

NCT06368752

H-22063621

Details and patient eligibility

About

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.

Full 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).

Enrollment

12 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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