Physiology of GIP(1-30)NH2 in Humans (GA-11)

March 10, 2021 updated by: Filip Krag Knop, University Hospital, Gentofte, Copenhagen
Glucose-dependent insulinotropic polypeptide (GIP) is a gut-derived incretin hormone that affects glucose, lipid and bone metabolism. Secretion of GIP into the blood stream from enteroendocrine cells is stimulated bu nutrients in the gut lumen and results in potentiation of glucose stimulated insulin secretion from the pancreas. The objective of this study is to investigate the physiology of GIP(1-30)NH2 in humans with insulin secretion as the primary endpoint. Furthermore the effects on on plasma/serum levels of glucagon, C-peptide, glucose, bone markers (CTX and P1NP) will be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Clinical Metabolic Physiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy men of Northern European descent
  • BMI: 19-25 kg/m2
  • Stable body weight (±5%) in the last three months

Exclusion Criteria:

  • Treatment with medication or dietary supplements that cannot be paused for 12 hours
  • More than 14 units of alcohol per week or abuse of narcotics
  • Established liver disease and/or plasma alanine aminotransferase (ALT) ≥3 × normal value and/or INR outside the normal range
  • Renal impairment (eGFR <60 ml/min/1.73 m2)
  • Severe arteriosclerotic heart disease or severe heart failure (NYHA group III or IV)
  • Low blood count (haemoglobin <8.3 mol/l)
  • Special diet or planned body weight change before the trial period
  • First-degree relatives with diabetes
  • Participation in other clinical experiments with medication
  • Any disease/condition that the investigators estimate disturbing for the participation in the experiment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Saline
Intravenous administration of saline during a stepwise glucose clamp
Experimental: GIP(1-42)
Other: GIP(1-42)
Intravenous administration of the peptide hormone GIP(1-42) during a stepwise glucose clamp
Experimental: GIP(1-30)NH2
Other: GIP(1-30)NH2
Intravenous administration of the peptide hormone GIP(1-30)NH2 during a stepwise glucose clamp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin
Time Frame: Up to 3 months
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucagon
Time Frame: Up to 3 months
Up to 3 months
C-peptide
Time Frame: Up to 3 months
Up to 3 months
Glucose
Time Frame: Up to 3 months
Up to 3 months
CTX
Time Frame: Up to 3 months
Up to 3 months
P1NP
Time Frame: Up to 3 months
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2018

Primary Completion (Actual)

August 23, 2018

Study Completion (Actual)

June 9, 2019

Study Registration Dates

First Submitted

March 6, 2021

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17039726

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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