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

NCT03702660 | Completed DMC

• 1 other identifier: GA-7
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glucagon

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

  8 weeks - 6 months

Study Arms (4)

GIP(3-30)NH2

EXPERIMENTAL

GIP receptor antagonist

Other: GIP(3-30)NH2; Other: Peripheral venous cannulation

Placebo

PLACEBO COMPARATOR

Placebo (saline infusions)

Other: Peripheral venous cannulation

GLP-1

ACTIVE COMPARATOR

Other: Peripheral venous cannulation; Other: GLP-1

GLP-1 + GIP(3-30)NH2

EXPERIMENTAL

Other: GIP(3-30)NH2; Other: Peripheral venous cannulation; Other: GLP-1

Interventions

GIP(3-30)NH2 OTHER

Peptide derived from the naturally occuring gut hormone GIP

GIP(3-30)NH2; GLP-1 + GIP(3-30)NH2

Peripheral venous cannulation OTHER

Intravenous access for infusions

GIP(3-30)NH2; GLP-1; GLP-1 + GIP(3-30)NH2; Placebo

GLP-1 OTHER

Peptide infusion

GLP-1; GLP-1 + GIP(3-30)NH2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead

Study Sites (1)

Center for Diabetes Research, Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Interventions

gastric inhibitory polypeptide (3-30)-amide; Glucagon-Like Peptide 1

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Signe Stensen, MD

  Center for Diabetes Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: October 11, 2018
• Study Start: August 1, 2017
• Primary Completion: January 23, 2018
• Study Completion: January 23, 2018
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)