Pancreatectomy; HyperglycemiaGA-19bNCT06895408
Separate and Combined Extrapancreatic Effects of GIP and GLP-1
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) are 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 75 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
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Feb 2025to 14 Jul 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total pancreatectomy
- Caucasians between 30-75 years of age
- Blood haemoglobin >7.0 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-1 receptor agonists within the last 3 months
- Renal impairment (estimated by estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2) and/or albuminuria
- Calcium related disease, hypo-/hyperthyroidism
- Known significant liver disease, plasma alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × normal value or INR (The international normalised ratio based on prothrombin time) outside the normal range
Show all 10Show fewer
- Severe arteriosclerotic heart disease or heart failure (New York Heart Association (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.
Denmark1 site
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, 2900
About this study
Official title: Separate and Combined Extrapancreatic Effects of Glucose-dependent Insulinotropic Polypeptide (GIP) and Glucagon-Like Peptide 1 (GLP-1)
The two gut-derived hormones, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 (GLP-1) are 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
Glucose-dependent Insulinotropic Polypeptide
Intravenous InfusionOther
Glucagon-Like Peptide 1
Intravenous InfusionOther
Glucose-dependent Insulinotropic Polypeptide and Glucagon-Like Peptide 1
Intravenous InfusionOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| GIP | Experimental | Intravenous infusion of glucose-dependent insulinotropic polypeptide Receives: Other: Intravenous Infusion |
| GLP-1 | Experimental | Intravenous infusion of glucagon-like peptide 1 Receives: Other: Intravenous Infusion |
| GIP + GLP-1 | Experimental | Intravenous infusion of glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 Receives: Other: Intravenous Infusion |
| Saline | Placebo comparator | Intravenous infusion of saline Receives: Other: Intravenous Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days
Measured: Up to two months
Plasma glucagon
Changes in plasma levels of glucagon (gut-derived) between interventions assessed through frequently blood sampling during the experimental days
Measured: Up to two months
Plasma Insulin/C-peptide
Changes in plasma levels of insulin/C-peptide between interventions assessed through frequently blood sampling during the experimental days
Measured: Up to two months
Plasma triglycerides
Changes in plasma triglycerides between interventions assessed through frequently blood sampling during the experimental days
Measured: Up to two months
Plasma CTX
Changes in CTX between interventions assessed through frequently blood sampling during the experimental days
Measured: Up to two months
Plasma PINP
Changes in plasma PINP between interventions assessed through frequently blood sampling during the experimental days
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 posted26 Mar 2025
- Study start19 Feb 2025
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asger Lund, MD, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895408
- Sponsor's protocol ID
- 101292 (H-21035117)
- Acronym
- GA-19b
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Krogh LSL, Hansen MB, Bergmann NC, Hansen CP, Hartmann B, Holst JJ, Knop FK, Lund AB, Gasbjerg LS. Acute GIP and GLP-1 Administration Exerts Differential Metabolic Effects in Totally Pancreatectomised Individuals. Diabetes Obes Metab. 2026 Aug;28(8):7280-7290. doi: 10.1111/dom.70940. Epub 2026 Jun 1.
PubMed 42225304
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. 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 (GIP) and Glucagon-Like Peptide 1 (GLP-1)
- ClinicalTrials.gov ID
- NCT06895408
- Acronym / sponsor ID
- GA-19b / 101292 (H-21035117)
- Conditions
- Pancreatectomy; Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 26 Mar 2025 (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) are 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 |
|---|---|---|
| GIP | Experimental | Other: Intravenous InfusionIntravenous infusion of glucose-dependent insulinotropic polypeptide |
| GLP-1 | Experimental | Other: Intravenous InfusionIntravenous infusion of glucagon-like peptide 1 |
| GIP + GLP-1 | Experimental | Other: Intravenous InfusionIntravenous infusion of glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 |
| Saline | Placebo comparator | Other: Intravenous InfusionIntravenous infusion of saline |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total pancreatectomy
- Caucasians between 30-75 years of age
- Blood haemoglobin >7.0 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-1 receptor agonists within the last 3 months
- Renal impairment (estimated by estimated glomerular filtration rate (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 InfusionGlucose-dependent Insulinotropic Polypeptide | Other | GIP |
| Intravenous InfusionGlucagon-Like Peptide 1 | Other | GLP-1 |
| Intravenous InfusionGlucose-dependent Insulinotropic Polypeptide and Glucagon-Like Peptide 1 | Other | GIP + GLP-1 |
| Intravenous InfusionSaline | Other | Saline |
Primary outcome
Plasma glucose
Time frame: Up to two months
Changes in plasma levels of glucose between interventions assessed through frequently blood sampling during the experimental days
Plasma glucagon
Time frame: Up to two months
Changes in plasma levels of glucagon (gut-derived) between interventions assessed through frequently blood sampling during the experimental days
Plasma Insulin/C-peptide
Time frame: Up to two months
Changes in plasma levels of insulin/C-peptide between interventions assessed through frequently blood sampling during the experimental days
Plasma triglycerides
Time frame: Up to two months
Changes in plasma triglycerides between interventions assessed through frequently blood sampling during the experimental days
Plasma CTX
Time frame: Up to two months
Changes in CTX between interventions assessed through frequently blood sampling during the experimental days
Plasma PINP
Time frame: Up to two months
Changes in plasma PINP between interventions assessed through frequently blood sampling during the experimental days
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 9 Sep 2025.
- Derived from this study: PubMed 42225304Krogh LSL, Hansen MB, Bergmann NC, Hansen CP, Hartmann B, Holst JJ, Knop FK, Lund AB, Gasbjerg LS. Acute GIP and GLP-1 Administration Exerts Differential Metabolic Effects in Totally Pancreatectomised Individuals. Diabetes Obes Metab. 2026 Aug;28(8):7280-7290. doi: 10.1111/dom.70940. Epub 2026 Jun 1.
- Individual participant dataSharing planned: Undecided
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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 9 Sep 2025. 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?
Plasma glucose (time frame: Up to two months). The study lists 6 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 NCT06895408, 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 9 Sep 2025.