Effect of GIP After a Meal in Patients With Type 2 Diabetes

NCT ID: NCT03702660

Last Updated: 2021-04-27

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

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-01-23

Brief Summary

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The aim of this study is to investigate the effects of antagonising GIP after a meal on plasma levels of glucagon. 10 participants are going through four experimental days each, where they ingest a meal and afterwards receive infusions of either GIP receptor antagonist, GLP-1, GIP receptor antagonist + GLP-1 or placebo (saline) in a randomised order. The primary endpoint of the study is plasma levels of glucagon, which we hypothesize will decrease with infusion of GIP receptor antagonist and/or with infusion of GLP-1.

Detailed Description

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Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GIP(3-30)NH2

GIP receptor antagonist

Group Type EXPERIMENTAL

GIP(3-30)NH2

Intervention Type OTHER

Peptide derived from the naturally occuring gut hormone GIP

Peripheral venous cannulation

Intervention Type OTHER

Intravenous access for infusions

Placebo

Placebo (saline infusions)

Group Type PLACEBO_COMPARATOR

Peripheral venous cannulation

Intervention Type OTHER

Intravenous access for infusions

GLP-1

Group Type ACTIVE_COMPARATOR

Peripheral venous cannulation

Intervention Type OTHER

Intravenous access for infusions

GLP-1

Intervention Type OTHER

Peptide infusion

GLP-1 + GIP(3-30)NH2

Group Type EXPERIMENTAL

GIP(3-30)NH2

Intervention Type OTHER

Peptide derived from the naturally occuring gut hormone GIP

Peripheral venous cannulation

Intervention Type OTHER

Intravenous access for infusions

GLP-1

Intervention Type OTHER

Peptide infusion

Interventions

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GIP(3-30)NH2

Peptide derived from the naturally occuring gut hormone GIP

Intervention Type OTHER

Peripheral venous cannulation

Intravenous access for infusions

Intervention Type OTHER

GLP-1

Peptide infusion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Caucasians between 18-75 years with diet og Metformin treated type 2-diabetes
* HbA1c \< 75 mmol/mol
* BMI \> 27 kg/m2
* Stable weight (+/- 5%) during the last 3 months

Exclusion Criteria

* Treatment with medicine or dietary supplements that cannot the paused for 12 hours
* More than 14 units of alcohol weekly or abuse of drugs
* Liver disease, estimated at plasma ALAT levels \> 3 x normal value or INR outside normal range
* Reduced kidney function (estimated at eGFR \< 60 ml/min/1,73 m2)
* Severe arteriosclerotic heart disease or heart failure (NYHA III or IV)
* Low red blood cell count (hemoglobin \< 8.3 mmol/l
* Special diet or planned weight change during the trial period
* Any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Signe Stensen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Signe Stensen, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Diabetes Research

Locations

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Center for Diabetes Research, Gentofte Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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GA-7

Identifier Type: -

Identifier Source: org_study_id

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