## Protocol Section
### Identification Module
**NCT ID:** NCT06419686

**Acronym:** GIPALANIN

**Brief Title:** The Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals

**Official Title:** The Separate and Combined Glucagonotropic Effects of Glucose-dependent Insulinotropic Polypeptide and Alanine in Healthy Individuals

#### Organization Study ID Info
**ID:** H-21066812
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Gentofte, Copenhagen
### Status Module
#### Completion Date
**Date:** 2024-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Gentofte, Copenhagen

#### Responsible Party

**Investigator Affiliation:** University Hospital, Gentofte, Copenhagen

**Investigator Full Name:** Filip Krag Knop

**Investigator Title:** MD PhD, Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study is a randomised, double-blinded, placebo-controlled, crossover study enrolling 10 healthy male participants. Each participant will undergo four separate study days in randomised order. Each study day encompasses a continous 90-minute i.v. infusion with either placebo, glucose-dependent insulinotropic polypeptide (GIP), alanine or GIP + alanine.

The primary objective of the study is to find out whether intravenous administration of the naturally occuring gut hormone GIP and the amino acid alanine, separately and combined, results in additive or synergistic glucagonotropic effects during euglycaemic conditions in healthy participants. Secondary objectives are to disclose the effect of the abovementioned interventions on insulin secretion and circulating levels of total and individual amino acids.

### Conditions Module

**Conditions:**

- Effect of iv Administration of GIP and Alanine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intravenous administration of saline for 90 minutes.

**Intervention Names:**

- Other: Placebo (saline)

**Label:** Saline

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** Intravenous administration of GIP for 90 minutes (priming dose 6 pmol/kg/min for 10 minutes and 4 pmol/kg for 80 minutes.

**Intervention Names:**

- Drug: GIP

**Label:** GIP

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Intravenous administration of alanine for 90 minutes (28 umol/kg/min).

**Intervention Names:**

- Drug: Alanine

**Label:** Alanine

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Intravenous administration of GIP and alanine for 90 minutes. GIP is given at a priming dose of 6 pmol/kg/min for 10 minutes and then 4 pmol/kg for 80 minutes. Alanine is given at 28 umol/kg/min for 90 minutes.

**Intervention Names:**

- Drug: GIP + alanine

**Label:** GIP + Alanine

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Saline

**Description:** Intravenous saline during experimental days.

**Name:** Placebo (saline)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- GIP

**Description:** Intravenous GIP administration during experimental days.

**Name:** GIP

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Alanine

**Description:** Intravenous alanine administration during experimental days.

**Name:** Alanine

**Type:** DRUG

#### Intervention 4

**Arm Group Labels:**

- GIP + Alanine

**Description:** Intravenous administration of GIP and alanine during experimental days.

**Name:** GIP + alanine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Baseline

**Measure:** Plasma concentrations of Glucagon

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC)

**Measure:** Plasma concentrations of Glucagon

**Time Frame:** Timepoint -30 to 90 minutes

#### Secondary Outcomes

**Description:** Baseline

**Measure:** Serum concentration of Insulin

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Serum concentration of Insulin

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline

**Measure:** Serum concentration of C-peptid

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Serum concentration of C-peptid

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline

**Measure:** Plasma concentration of glucose

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Plasma concentration of glucose

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Peak value

**Measure:** Plasma concentration of glucose

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline

**Measure:** Plasma concentration of GIP

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Plasma concentration of GIP

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline

**Measure:** Circulating levels of total amino acids

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Circulating levels of total amino acids

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline

**Measure:** Circulating levels of individual amino acids

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Circulating levels of individual amino acids

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline

**Measure:** Lipid profile

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Lipid profile

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline

**Measure:** Circulating levels of CTx

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Circulating levels of CTx

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline

**Measure:** Circulating levels of P1NP

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Circulating levels of P1NP

**Time Frame:** Timepoint -30 to 90 minutes

**Description:** Baseline

**Measure:** Blood pressure

**Time Frame:** Timepoint -30, 0, 30, 60, 90

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Blood pressure

**Time Frame:** Timepoint -30, 0, 30, 60, 90

**Description:** Baseline

**Measure:** Pulse

**Time Frame:** Timepoint -30, 0, 30, 60, 90

**Description:** Baseline-corrected area under the curve (bsAUC).

**Measure:** Pulse

**Time Frame:** Timepoint -30, 0, 30, 60, 90

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Caucasian ethnicity
* Body mass index (BMI) 20-27 kg/m\^2
* Glycated haemoglobin (HbA1c) ≤ 42 mmol/mol
* Informed and written consent

Exclusion Criteria:

* Late microvascular complications except mild nonproliferative retinopathy
* Liver disease (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \> 2 times normal values) or history of hepatobiliary disorder
* Treatment with any glucose-lowering drugs
* Active or recent (within 5 years) malignant disease
* Active tobacco smoking/use
* Any condition considered incompatible with participation by the investigators.

**Healthy Volunteers:** True

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** julie.vilhelmine.warnoee.nielsen@regionh.dk

**Name:** Julie V Warnøe, MD

**Phone:** +4527282263

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hellerup

**Contacts:**

***Contact 1:***

- **Email:** filip.krag.knop.01@regionh.dk

- **Name:** Filip K. Knop, MD, PhD

- **Phone:** +4526830161

- **Role:** CONTACT

***Contact 2:***

- **Name:** Julie V. Warnøe, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Denmark

**Facility:** Center for Clinical Metabolic Research, Gentofte Hospital

**State:** Capital Region

**Status:** RECRUITING

**Zip:** 2900

#### Overall Officials

**Official 1:**

**Affiliation:** Center for Clinical Metabolic Research, Gentofte Hospital

**Name:** Filip K Knop, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AA

- Name: Amino Acids

### Intervention Browse Module - Browse Leaves

- ID: M8866

- Name: Gastric Inhibitory Polypeptide

- Relevance: LOW

- As Found: Unknown

- ID: T0

- Name: Alanine

- Relevance: HIGH

- As Found: Transversus abdominis

### Misc Info Module

- Version Holder: 2024-05-31
