Pancreatectomy; HyperglycemiaGA-19NCT05177653
Separate and Combined Extrapancreatic Effects of the Incretin Hormones
A study testing Intravenous infusion in people with Pancreatectomy; Hyperglycemia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pancreatectomy; Hyperglycemia
- What is being tested?
- Intravenous infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Apr 2022to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total pancreatectomy
- Caucasians
- Blood haemoglobin >7 mmol/l for males and >6.5 mmol/l for females
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Separate and Combined Extrapancreatic Effects of Glucose-dependent Insulinotropic Polypeptide and Glucagon-like Peptide 1
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.
- Conditions
- Pancreatectomy; Hyperglycemia
- Being tested
- Intravenous infusion
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous infusionOther
GIP receptor antagonist (GIP(3-30)NH2)
Intravenous infusionOther
GLP-1 receptor antagonist (exendin(9-39)NH2)
Intravenous infusionOther
GIP(3-30)NH2 and exendin(9-39)NH2
Intravenous infusionOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| GIPRA | Experimental | Not described Receives: Other: Intravenous infusion |
| GLP-1RA | Experimental | Not described Receives: Other: Intravenous infusion |
| GIPRA + GLP-1RA | Experimental | Not described Receives: Other: Intravenous infusion |
| Saline | Placebo comparator | Not described Receives: Other: Intravenous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days
mmol/l
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to two months
Changes in plasma lipoproteins between interventions assessed through frequently blood sampling during the experimental days.
mg/dl
Measured: Up to two months
Changes in brown adipose tissue activity between interventions, assessed by thermographic camera
Measured: Up to two months
Changes in adiponectin in plasma between interventions, assessed through frequently blood sampling during the experimental days.
μg/mL
Measured: Up to two months
Changes in CTX between interventions assessed through frequently blood sampling during the experimental days
ng/ml
Measured: Up to two months
Changes in plasma P1NP between interventions assessed through frequently blood sampling during the experimental days
ng/ml
Measured: Up to two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start7 Apr 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatectomy; HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177653
- Sponsor's protocol ID
- H-21035117
- Acronym
- GA-19
- Status last verified
- Mar 2023
- First submitted
- 16 Nov 2021
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Krogh LSL, Helsted MM, Englund A, Bergmann NC, Skov-Jeppesen K, Nielsen CK, Hansen CP, Rosenkilde MM, Hartmann B, Holst JJ, Knop FK, Lund AB, Gasbjerg LS. Acute effects of GIP and GLP-1 receptor antagonism in totally pancreatectomized individuals: A randomized double-blind, placebo-controlled crossover study. Diabetes Obes Metab. 2026 Jan;28(1):275-286. doi: 10.1111/dom.70186. Epub 2025 Oct 10.
PubMed 41069310
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Separate and Combined Extrapancreatic Effects of Glucose-dependent Insulinotropic Polypeptide and Glucagon-like Peptide 1
- ClinicalTrials.gov ID
- NCT05177653
- Acronym / sponsor ID
- GA-19 / H-21035117
- Conditions
- Pancreatectomy; Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GIPRA | Experimental | Other: Intravenous infusion |
| GLP-1RA | Experimental | Other: Intravenous infusion |
| GIPRA + GLP-1RA | Experimental | Other: Intravenous infusion |
| Saline | Placebo comparator | Other: Intravenous infusion |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total pancreatectomy
- Caucasians
- Blood haemoglobin >7 mmol/l for males and >6.5 mmol/l for females
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous infusionGIP receptor antagonist (GIP(3-30)NH2) | Other | GIPRA |
| Intravenous infusionGLP-1 receptor antagonist (exendin(9-39)NH2) | Other | GLP-1RA |
| Intravenous infusionGIP(3-30)NH2 and exendin(9-39)NH2 | Other | GIPRA + GLP-1RA |
| Intravenous infusionSaline | Other | Saline |
Primary outcome
Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days
Time frame: Up to two months
mmol/l
Changes in plasma levels of glucagon (gut-derived) between interventions assessed through frequently blood sampling during the experimental days
Time frame: Up to two months
pmol/l
Changes in plasma levels of insulin/C-peptide between interventions assessed through frequently blood sampling during the experimental days
Time frame: Up to two months
pmol/l
Changes in plasma triglycerides between interventions assessed through frequently blood sampling during the experimental days.
Time frame: Up to two months
mmol/l lipoproteins, neutral and complex lipids.
Changes in plasma lipoproteins between interventions assessed through frequently blood sampling during the experimental days.
Time frame: Up to two months
mg/dl
Changes in brown adipose tissue activity between interventions, assessed by thermographic camera
Time frame: Up to two months
Changes in adiponectin in plasma between interventions, assessed through frequently blood sampling during the experimental days.
Time frame: Up to two months
μg/mL
Changes in CTX between interventions assessed through frequently blood sampling during the experimental days
Time frame: Up to two months
ng/ml
Changes in plasma P1NP between interventions assessed through frequently blood sampling during the experimental days
Time frame: Up to two months
ng/ml
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 41069310Krogh LSL, Helsted MM, Englund A, Bergmann NC, Skov-Jeppesen K, Nielsen CK, Hansen CP, Rosenkilde MM, Hartmann B, Holst JJ, Knop FK, Lund AB, Gasbjerg LS. Acute effects of GIP and GLP-1 receptor antagonism in totally pancreatectomized individuals: A randomized double-blind, placebo-controlled crossover study. Diabetes Obes Metab. 2026 Jan;28(1):275-286. doi: 10.1111/dom.70186. Epub 2025 Oct 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous infusion in people with Pancreatectomy; Hyperglycemia, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days (time frame: Up to two months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05177653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.