Clinical trial NCT06368752: The Role of Endogenous GIP in Glycosis Metabolism During Fasting
Official title: GA-18: The Role of Endogenous GIP in Glycosis Metabolism During Fasting
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Obesity
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The trial is a randomized, double-blind, crossover study. We give intravenous infusion of GIP\[3-30\]NH2, and thus describe the effects of GIP by comparing with what happens during a saline infusion (placebo).
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Plasma glucagon concentrations
timeFrame: Four hours
Secondary outcomes:
measure: Plasma levels of C-peptide
timeFrame: Four hours
measure: Plasma levels of insulin
timeFrame: Four hours
measure: Resting metabolic rate
timeFrame: 15 minutes
measure: Activity in brown adipose tissue
timeFrame: 10 minutes
measure: Appetite
timeFrame: 30 minutes
measure: Blood pressure
timeFrame: 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.
measure: Puls
timeFrame: 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
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
References: