## Protocol Section
### Identification Module
**NCT ID:** NCT06426823

**Acronym:** GA-17b

**Brief Title:** The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes

**Official Title:** The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes

#### Organization Study ID Info
**ID:** GA-17b
#### Organization
**Class:** OTHER
**Full Name:** University of Copenhagen
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Rigshospitalet, Denmark

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Copenhagen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Blood Flow

**Keywords:**

- Gut hormones

- GIP

- Physiology

- Type 2 diabetes

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Single blind, placebo controlled, randomized, crossover study

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Saline infusion, oral water ingestion

**Intervention Names:**

- Other: Saline / placebo

**Label:** Saline and oral water (SAL-WAT)

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Saline infusion, oral glucose ingestion

**Intervention Names:**

- Other: Saline / placebo

**Label:** Saline infusion and oral glucose ingestion (SAL-GLU)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** GIPR antagonist infusion, oral water ingestion

**Intervention Names:**

- Other: GIPR antagonist / study tool

**Label:** GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT)

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** GIPR antagonist infusion, oral glucose ingestion

**Intervention Names:**

- Other: GIPR antagonist / study tool

**Label:** GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Saline and oral water (SAL-WAT)

- Saline infusion and oral glucose ingestion (SAL-GLU)

**Description:** NaCl (9 mg/ml)

**Name:** Saline / placebo

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU)

- GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT)

**Description:** GIP(3-30)NH2

**Name:** GIPR antagonist / study tool

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Measued with phase-contrast MRI in ml/min

**Measure:** Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (functional MRI)

**Time Frame:** 80 minutes

#### Secondary Outcomes

**Description:** Radioimmuno assay on plasma blood sample (pmol/L)

**Measure:** GIP levels

**Time Frame:** 80 minutes

**Description:** Radioimmuno assay on plasma blood sample (nmol/L)

**Measure:** GIP(3-30)NH2 levels

**Time Frame:** 80 minutes

**Description:** Bedside measurement of whole blood sample (mmol/L)

**Measure:** Glucose

**Time Frame:** 80 minutes

**Description:** Electrochemiluminescence immunoassay of plasma blood sample (pmol/L)

**Measure:** C-peptide

**Time Frame:** 80 minutes

**Description:** Electrochemiluminescence immunoassay of plasma blood sample (pmol/L)

**Measure:** Insulin

**Time Frame:** 80 minutes

**Description:** Radioimmuno assay on plasma blood samples (pmol/L)

**Measure:** Glucagon

**Time Frame:** 80 minutes

**Description:** Measued with phase-contrast MRI in ml/min

**Measure:** Blood flow in portal vein

**Time Frame:** 80 minutes

**Description:** Measued with phase-contrast MRI in ml/min

**Measure:** Blood flow in coeliac trunc

**Time Frame:** 80 minutes

**Description:** Measued with phase-contrast MRI in ml/min

**Measure:** Blood flow in hepatic artery

**Time Frame:** 80 minutes

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lsg@sund.ku.dk

**Name:** Lærke S Gasbjerg, MD PhD

**Phone:** 25346894

**Phone Ext:** +45

**Role:** CONTACT

**Contact 2:**

**Email:** rasmus.syberg@sund.ku.dk

**Name:** Rasmus S Rasmussen, Cand.scient.

**Phone:** 50534173

**Phone Ext:** +45

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Copenhagen

**Contacts:**

***Contact 1:***

- **Email:** lsg@sund.ku.dk

- **Name:** Lærke S Gasbjerg

- **Role:** CONTACT

**Country:** Denmark

**Facility:** Rigshospitalet

**Status:** RECRUITING

**Zip:** 2200

### IPD Sharing Statement Module

**Description:** Will share upon requests

**IPD Sharing:** YES

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-05-17

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1602889

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-17T06:14

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Type 2 Diabetes

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M11449

- Name: Mechlorethamine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
