NCT05177653

Brief Summary

The two gut-derived hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) is secreted from intestinal cells in relation to a meal and increase insulin secretion from the pancreas. The hormones also exert effects outside the pancreas, but especially for GIP, these are poorly investigated. Because of this, only GLP-1 based drugs (GLP-1 receptor agonists) are on the market for the treatment of type 2 diabetes and obesity. Nonetheless, a new drug is in clinical development: a combined GIP-GLP-1-receptor agonist (tirzepatide), which has shown better results than GLP-1 alone. The mechanism behind these impressive effects are unknown and in this study, the investigators will look into the exptrapancreatic effects of GIP and GLP-1, separate and combined and thus elucidate the mechanisms of action of this new drug class.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2023

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

November 16, 2021

Last Update Submit

March 28, 2023

Conditions

Pancreatectomy; Hyperglycemia

Outcome Measures

Primary Outcomes (9)

  • Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days

    mmol/l

    Up to two months

  • Changes in plasma levels of glucagon (gut-derived) between interventions assessed through frequently blood sampling during the experimental days

    pmol/l

    Up to two months

  • Changes in plasma levels of insulin/C-peptide between interventions assessed through frequently blood sampling during the experimental days

    pmol/l

    Up to two months

  • Changes in plasma triglycerides between interventions assessed through frequently blood sampling during the experimental days.

    mmol/l lipoproteins, neutral and complex lipids.

    Up to two months

  • Changes in plasma lipoproteins between interventions assessed through frequently blood sampling during the experimental days.

    mg/dl

    Up to two months

  • Changes in brown adipose tissue activity between interventions, assessed by thermographic camera

    Up to two months

  • Changes in adiponectin in plasma between interventions, assessed through frequently blood sampling during the experimental days.

    μg/mL

    Up to two months

  • Changes in CTX between interventions assessed through frequently blood sampling during the experimental days

    ng/ml

    Up to two months

  • Changes in plasma P1NP between interventions assessed through frequently blood sampling during the experimental days

    ng/ml

    Up to two months

Study Arms (4)

GIPRA

EXPERIMENTAL
Other: Intravenous infusion

GLP-1RA

EXPERIMENTAL
Other: Intravenous infusion

GIPRA + GLP-1RA

EXPERIMENTAL
Other: Intravenous infusion

Saline

PLACEBO COMPARATOR
Other: Intravenous infusion

Interventions

Intravenous infusionOTHER

GIP receptor antagonist (GIP(3-30)NH2)

GIPRA

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Total pancreatectomy
  • Caucasians
  • Blood haemoglobin \>7 mmol/l for males and \>6.5 mmol/l for females

You may not qualify if:

  • Pancreatectomy within the last 3 months
  • Ongoing chemotherapy or chemotherapy within the last 3 months
  • Treatment with GLP-1R agonists within the last 3 months
  • Renal impairment (estimated by eGFR \<60 ml/min/1.73 m2) and/or albuminuria
  • Calcium related disease, hypo-/hyperthyroidism
  • Known significant liver disease, ALT or AST \>3 times normal value or INR outside normal range
  • Severe arteriosclerotic heart disease or heart failure (NYHA group III or IV)
  • Pregnancy and/or breastfeeding
  • Use of more than 14 units of alcohol per week or abuse of narcotics
  • Any condition that the investigator feels would interfere with trial participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Hyperglycemia

Interventions

Infusions, Intravenous

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Administration, IntravenousDrug Administration RoutesDrug TherapyTherapeuticsInfusions, Parenteral

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
Professor

Study Record Dates

First Submitted

November 16, 2021

First Posted

January 4, 2022

Study Start

April 7, 2022

Primary Completion

March 3, 2023

Study Completion

March 3, 2023

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)