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Effect of GIP After a Meal in Patients With Type 2 Diabetes (GA-7)

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GIP(3-30)NH2
Peripheral venous cannulation
GLP-1
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type2 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Diabetes Research, Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Experimental

Arm Label

GIP(3-30)NH2

Placebo

GLP-1

GLP-1 + GIP(3-30)NH2

Arm Description

GIP receptor antagonist

Placebo (saline infusions)

Outcomes

Primary Outcome Measures

Glucagon
Plasma levels of glucagon after a meal in patients with type 2-diabetes

Secondary Outcome Measures

Full Information

First Posted
October 30, 2017
Last Updated
April 23, 2021
Sponsor
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT03702660
Brief Title
Effect of GIP After a Meal in Patients With Type 2 Diabetes
Acronym
GA-7
Official Title
Effect of GIP-receptorantantagonist on Glucagon Plasma Levels After a Meal in Patients With Type 2-diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 23, 2018 (Actual)
Study Completion Date
January 23, 2018 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
GIP(3-30)NH2
Arm Type
Experimental
Arm Description
GIP receptor antagonist
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (saline infusions)
Arm Title
GLP-1
Arm Type
Active Comparator
Arm Title
GLP-1 + GIP(3-30)NH2
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
GIP(3-30)NH2
Intervention Description
Peptide derived from the naturally occuring gut hormone GIP
Intervention Type
Other
Intervention Name(s)
Peripheral venous cannulation
Intervention Description
Intravenous access for infusions
Intervention Type
Other
Intervention Name(s)
GLP-1
Intervention Description
Peptide infusion
Primary Outcome Measure Information:
Title
Glucagon
Description
Plasma levels of glucagon after a meal in patients with type 2-diabetes
Time Frame
8 weeks - 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Signe Stensen, MD
Organizational Affiliation
Center for Diabetes Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Diabetes Research, Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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