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

Primary Purpose

Glucose Metabolism Disorders

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GIP(1-30)NH2
GIP(1-42)
Saline
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Metabolism Disorders

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Clinical Metabolic Physiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

GIP(1-42)

GIP(1-30)NH2

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Insulin

Secondary Outcome Measures

Glucagon
C-peptide
Glucose
CTX
P1NP

Full Information

First Posted
March 6, 2021
Last Updated
March 10, 2021
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT04792762
Brief Title
Physiology of GIP(1-30)NH2 in Humans
Acronym
GA-11
Official Title
Physiology of GIP(1-30)NH2 in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
June 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GIP(1-42)
Arm Type
Experimental
Arm Title
GIP(1-30)NH2
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
GIP(1-30)NH2
Intervention Description
Intravenous administration of the peptide hormone GIP(1-30)NH2 during a stepwise glucose clamp
Intervention Type
Other
Intervention Name(s)
GIP(1-42)
Intervention Description
Intravenous administration of the peptide hormone GIP(1-42) during a stepwise glucose clamp
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Intravenous administration of saline during a stepwise glucose clamp
Primary Outcome Measure Information:
Title
Insulin
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Glucagon
Time Frame
Up to 3 months
Title
C-peptide
Time Frame
Up to 3 months
Title
Glucose
Time Frame
Up to 3 months
Title
CTX
Time Frame
Up to 3 months
Title
P1NP
Time Frame
Up to 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Clinical Metabolic Physiology
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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Physiology of GIP(1-30)NH2 in Humans

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