Diabetes After Total PancreatectomyNCT04064203
The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion (Px-Hypo)
A study testing Oral glucose tolerance test and Clamp experiment in people with Diabetes After Total Pancreatectomy, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The overall objective of this study is to investigate whether hypoglycaemia (the most potent stimulus of pancreatic glucagon secretion) affects the secretion of gut-derived glucagon in totally pancreatectomized patients. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes After Total Pancreatectomy
- What is being tested?
- Oral glucose tolerance test and Clamp experiment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jul 2017to 20 Sep 2018
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pancreatectomised patients
- Caucasian above 30 years of age who have undergone total pancreatectomy
- Blood haemoglobin >7.0 mmol/l for males and >6.5 mmol/l for females Non-diabetic control subjects
- Normal fasting plasma glucose and normal HbA1c (according to the World Health Organization (WHO) criteria)
- Normal blood haemoglobin
- Caucasian above 30 years of age
- BMI (body mass index) 17-30
- Informed consent
Who cannot join
- Pancreatectomised patients
- Pancreatectomy within the last 3 months
- Ongoing chemotherapy or chemotherapy within the last 3 months
- Previous or ongoing treatment with GLP-1 receptor agonists or dipeptidyl peptidase 4 (DPP-4) inhibitors
- Inflammatory bowel disease
- Gastrointestinal resection (other than the gastro-duodenectomy performed in connection with total pancreatectomy) and/or ostomy
Show all 24Show fewer
- Nephropathy (eGFR<60 and/or albuminuria)
- Known liver disease (excluding non-alcoholic fatty liver disease) and/or serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >3 × normal values)
- Severe lung disease
- Pregnancy and/or breastfeeding
- Age above 85 years
- Uncontrolled hypertension and/or significant cardiovascular disease
- Any condition that the investigator feels would interfere with trial participation Non-diabetic control subjects
- Diabetes or prediabetes (according to WHO criteria)
- First-degree relatives with diabetes
- Inflammatory bowel disease
- Gastrointestinal resection and/or ostomy
- Nephropathy (serum creatinine >150 µmol/l and/or albuminuria)
- Known liver disease (excluding non-alcoholic fatty liver disease) and/or serum ALAT and/or serum ASAT >3 × normal values)
- Severe lung disease
- Pregnancy and/or breastfeeding
- Age above 85 years
- Uncontrolled hypertension and/or significant cardiovascular disease
- 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
Hellerup, Capital Region, 2900
About this study
Official title: The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion
The overall objective of this study is to investigate whether hypoglycaemia (the most potent stimulus of pancreatic glucagon secretion) affects the secretion of gut-derived glucagon in totally pancreatectomized patients.
Read the detailed description
The investigators want to assess the plasma glucagon response to insulin-induced hypoglycaemia in totally pancreatectomised patients and at the same time evaluate whether hypoglycaemia affects a range of other products from endocrine cells in the gastrointestinal tract including ghrelin, gastrin, cholecystokinin (CCK), glucose-dependent insulinotropic polypeptide (GIP), GLP-1, glucagon-like peptide-2 (GLP-2), oxyntomodulin and peptide YY (PYY). Furthermore the investigators will evaluate how hypoglycaemia in these patients affects other counter-regulatory mechanisms including plasma responses of the hormones adrenaline, noradrenaline, growth hormone and cortisol as well as the rate of gastric emptying rate (which under normal circumstances accelerates during hypoglycaemia) during an oral glucose tolerance test (OGTT).
- Conditions
- Diabetes After Total Pancreatectomy
- Being tested
- Oral glucose tolerance test, Clamp experiment
- Keywords
- glucagon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testOther
50 grams OGTT
Clamp experimentOther
insulin-induced hypoglycaemic clamp followed by an 50 grams OGTT
| Study group | Role | What they receive |
|---|---|---|
| Totally pancreatectomized patients | Experimental | Oral glucose tolerance test + insulin-induced hypoglycaemic clamp followed by an oral glucose tolerance test Receives: Other: Oral glucose tolerance test; Other: Clamp experiment |
| Healthy controls | Experimental | Oral glucose tolerance test + insulin-induced hypoglycaemic clamp followed by an oral glucose tolerance test Receives: Other: Oral glucose tolerance test; Other: Clamp experiment |
What is being measured
The primary outcome is the main question the study is designed to answer.
p-glucagon
Plasma glucagon excursions measured as incremental area under the curve (iAUC)
Measured: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes
Secondary outcomes (5)
p-glucose
plasma glucose excursions measured as incremental area under the curve (iAUC)
Measured: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes
GIP, GLP-1, GLP-2, GIP, oxyntomodulin, ghrelin, peptide YY, gastrin
excursions in Gut hormones measured as incremental area under the curve (iAUC)
Measured: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes
catecholamines
p-adrenaline and p-noradrenaline, excursions measured as incremental area under the curve (iAUC)
Measured: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes
cortisol
p-cortisol excursions measured as incremental area under the curve (iAUC)
Measured: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes
growth hormone
p-growth hormone excursions measured as incremental area under the curve (iAUC)
Measured: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start5 Jul 2017
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes After Total PancreatectomyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 12 totally pancreatectomized patients and 12 healthy control subjects
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Filip Krag Knop, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064203
- Sponsor's protocol ID
- H-17014216
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion
- ClinicalTrials.gov ID
- NCT04064203
- Acronym / sponsor ID
- H-17014216
- Conditions
- Diabetes After Total Pancreatectomy
- Keywords
- glucagon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 21 Aug 2019 (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 overall objective of this study is to investigate whether hypoglycaemia (the most potent stimulus of pancreatic glucagon secretion) affects the secretion of gut-derived glucagon in totally pancreatectomized patients.
Detailed description
The investigators want to assess the plasma glucagon response to insulin-induced hypoglycaemia in totally pancreatectomised patients and at the same time evaluate whether hypoglycaemia affects a range of other products from endocrine cells in the gastrointestinal tract including ghrelin, gastrin, cholecystokinin (CCK), glucose-dependent insulinotropic polypeptide (GIP), GLP-1, glucagon-like peptide-2 (GLP-2), oxyntomodulin and peptide YY (PYY). Furthermore the investigators will evaluate how hypoglycaemia in these patients affects other counter-regulatory mechanisms including plasma responses of the hormones adrenaline, noradrenaline, growth hormone and cortisol as well as the rate of gastric emptying rate (which under normal circumstances accelerates during hypoglycaemia) during an oral glucose tolerance test (OGTT).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 12 totally pancreatectomized patients and 12 healthy control subjects
| Arm | Type | Receives |
|---|---|---|
| Totally pancreatectomized patients | Experimental | Other: Oral glucose tolerance test, Other: Clamp experimentOral glucose tolerance test + insulin-induced hypoglycaemic clamp followed by an oral glucose tolerance test |
| Healthy controls | Experimental | Other: Oral glucose tolerance test, Other: Clamp experimentOral glucose tolerance test + insulin-induced hypoglycaemic clamp followed by an oral glucose tolerance test |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pancreatectomised patients
- Caucasian above 30 years of age who have undergone total pancreatectomy
- Blood haemoglobin >7.0 mmol/l for males and >6.5 mmol/l for females Non-diabetic control subjects
- Normal fasting plasma glucose and normal HbA1c (according to the World Health Organization (WHO) criteria)
- Normal blood haemoglobin
Key exclusion criteria (24 listed)
- Pancreatectomised patients
- Pancreatectomy within the last 3 months
- Ongoing chemotherapy or chemotherapy within the last 3 months
- Previous or ongoing treatment with GLP-1 receptor agonists or dipeptidyl peptidase 4 (DPP-4) inhibitors
- Inflammatory bowel disease
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 |
|---|---|---|
| Oral glucose tolerance test50 grams OGTT | Other | Healthy controls, Totally pancreatectomized patients |
| Clamp experimentinsulin-induced hypoglycaemic clamp followed by an 50 grams OGTT | Other | Healthy controls, Totally pancreatectomized patients |
Primary outcome
p-glucagon
Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes
Plasma glucagon excursions measured as incremental area under the curve (iAUC)
5 secondary outcomes
p-glucose
Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes
GIP, GLP-1, GLP-2, GIP, oxyntomodulin, ghrelin, peptide YY, gastrin
Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes
catecholamines
Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes
cortisol
Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes
growth hormone
Time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90 minutes
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 21 Aug 2019.
- 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 Oral glucose tolerance test and Clamp experiment in people with Diabetes After Total Pancreatectomy, 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 8 inclusion and 24 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 21 Aug 2019. 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. 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?
p-glucagon (time frame: -30, -15, 0, 15, 40, 50, 60, 70, 80, 90, 105, 120, 135, 150, 165, 180, 210, 240 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2019.