The Role of Endogenous GIP in Glycosis Metabolism During Fasting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-04

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

The infusion is mixed by an external coordinator. Neither the investigator or the participants knows whether is the GIP\[3-30\]NH2 infusion or saline infusion that is being given. Which infusion that is given on each trial day is randomized for each participant.

Study Groups

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GIP[3-30]NH2 infusion

GIP\[3-30\]NH2 intravenous infusion (800 pmol/kg/min)

Group Type EXPERIMENTAL

GIP[3-30]NH2

Intervention Type BIOLOGICAL

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

Saline infusion

Saline intravenous infusion (0,5 % human serum albumin)

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Sodium chlorid with 0,5% human serum albumin.

Interventions

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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

Intervention Type BIOLOGICAL

Saline

Sodium chlorid with 0,5% human serum albumin.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes