The Role of Endogenous GIP in Glycosis Metabolism During Fasting

NCT06368752 | Enrolling By Invitation Early Phase 1 DMC

• 1 other identifier: H-22063621
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Plasma levels of C-peptide

  Four hours

• Plasma levels of insulin

  Four hours

• Resting metabolic rate

  15 minutes

• Activity in brown adipose tissue

  10 minutes

• Appetite

  30 minutes

Study Arms (2)

GIP[3-30]NH2 infusion

EXPERIMENTAL

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

Biological: GIP[3-30]NH2

Saline infusion

PLACEBO COMPARATOR

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

Other: Saline

Interventions

GIP[3-30]NH2 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

GIP[3-30]NH2 infusion

Saline OTHER

Sodium chlorid with 0,5% human serum albumin.

Saline infusion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• BMI \> 30 kg/m2
• Body fat percentage \> 25 % for men og \> 35 % for women

You may not qualify if:

• 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

Sponsors & Collaborators

• Frederikke Koefoed-Hansen: lead

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Obesity

Interventions

gastric inhibitory polypeptide (3-30)-amide; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Student

Model Details: 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).

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: April 16, 2024
• Study Start: May 4, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 31, 2025
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: December 31st. 2025

Locations

DK (1)