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CompletedNCT05177653GA-19Updated Mar 29, 2023

Separate and Combined Extrapancreatic Effects of the Incretin Hormones

An interventional study of Intravenous infusion and Intravenous infusion in Pancreatectomy; Hyperglycemia, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-03-29.

Sponsored by University Hospital, Gentofte, Copenhagen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pancreatectomy; Hyperglycemia

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03

In context

Hyperglycemia

699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.

This study's enrollment of 13 is below the median of 46 across 521 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

University Hospital, Gentofte, Copenhagen is the lead sponsor of 154 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    GIPRA

    Other: Intravenous infusion

  • Experimental
    GLP-1RA

    Other: Intravenous infusion

  • Experimental
    GIPRA + GLP-1RA

    Other: Intravenous infusion

  • Placebo comparator
    Saline

    Other: Intravenous infusion

Interventions

  • OtherIntravenous infusion

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

  • OtherIntravenous infusion

    GLP-1 receptor antagonist (exendin(9-39)NH2)

  • OtherIntravenous infusion

    GIP(3-30)NH2 and exendin(9-39)NH2

  • OtherIntravenous infusion

    Saline

06

What researchers measure

Primary outcomes

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

    mmol/l

    Time frame: Up to two months

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

    pmol/l

    Time frame: Up to two months

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

    pmol/l

    Time frame: Up to two months

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

    mmol/l lipoproteins, neutral and complex lipids.

    Time frame: Up to two months

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

    mg/dl

    Time frame: Up to two months

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

    Time frame: Up to two months

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

    μg/mL

    Time frame: Up to two months

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

    ng/ml

    Time frame: Up to two months

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

    ng/ml

    Time frame: Up to two months

07

Study locations

1 site
  • Center for Clinical Metabolic Research
    Hellerup, 2900, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05177653
Lead sponsor
University Hospital, Gentofte, Copenhagen
Responsible party
Filip Krag Knop (Professor, University Hospital, Gentofte, Copenhagen) — Principal investigator
First posted
Jan 4, 2022
Start date
Apr 7, 2022
Primary completion
Mar 3, 2023
Completion
Mar 3, 2023
Last update
Mar 29, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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