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The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes (GA-17b)

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University of Copenhagen

Status

Enrolling

Conditions

Blood Flow

Treatments

Other: GIPR antagonist / study tool
Other: Saline / placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

This project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with type 2 diabetes.

Full description

Each participant will attend four independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose/water): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes on two of the experimental days (with and without GIP(3-30)NH2).

MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines, pancreas, and bones.

Enrollment

10 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 2 diabetes
  • BMI 20-35 kg/m^2
  • Age 20-80

Exclusion criteria

  • Not MRI-compatible implants
  • Claustrophobia
  • Abnormal kidney or liver function
  • Anemia
  • Planned weight loss or change in diet
  • Hypertension
  • Other conditions that could be expected to affect the primary or secondary outcomes

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

10 participants in 4 patient groups, including a placebo group

Saline and oral water (SAL-WAT)
Placebo Comparator group
Description:
Saline infusion, oral water ingestion
Treatment:
Other: Saline / placebo
Saline infusion and oral glucose ingestion (SAL-GLU)
Active Comparator group
Description:
Saline infusion, oral glucose ingestion
Treatment:
Other: Saline / placebo
GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT)
Experimental group
Description:
GIPR antagonist infusion, oral water ingestion
Treatment:
Other: GIPR antagonist / study tool
GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU)
Experimental group
Description:
GIPR antagonist infusion, oral glucose ingestion
Treatment:
Other: GIPR antagonist / study tool

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Rasmus S Rasmussen, Cand.scient.; Lærke S Gasbjerg, MD PhD

Data sourced from clinicaltrials.gov

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