Glucose Metabolism DisordersNCT03181191
The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion
A study testing Oral glucose tolerance test in people with Glucose Metabolism Disorders, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
Delineation of the anatomical location, cellular origin and molecular basis of gut-derived glucagon secretion Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders
- What is being tested?
- Oral glucose tolerance test
- 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
- 27 Apr 2017to 3 Dec 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal kidney function, normal liver function, normal hemoglobin levels
Who cannot join
- diabetes type 1, first degree relatives with type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Delineation of the anatomical location, cellular origin and molecular basis of gut-derived glucagon secretion
Read the detailed description
Aim: to delineate the anatomical origin, the molecular structure and precursors, the regulation and the (patho-) physiological implications of gut-derived glucagon.
Eight totally pancreatectomised patients, eight type 2 diabetes patients and eight healthy controls (age 18-80, BMI <30) with normal kidney and liver parameters and hgb> 6.5 - will be included. The participants will each undergo one screening day and one study day including a gastroduodenoscopy. Multiple biopsies will be taken at several predefined locations in the upper gastrointestinal tract. These biopsies will be analysed with different techniques including immunohistochemical staining, quantitative polymerase chain reaction (qPCR-) analyses and more to search for glucagon. After the last biopsy has been collected, 50 g of glucose dissolved in 100 ml water is infused through the enteroscope into the most proximal part of the small intestine. Hereafter blood samples for glucagon and gut hormone analyses will be collected 15, 30 and 45 min after the glucose infusion.
- Conditions
- Glucose Metabolism Disorders
- Being tested
- Oral glucose tolerance test
- Medical subject headings
- Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testOther
Oral glucose tolerance test and biopsies
| Study group | Role | What they receive |
|---|---|---|
| Totally pancreatectomised patients | Active comparator | Oral glucose tolerance test and biopsies Receives: Other: Oral glucose tolerance test |
| Type 2 diabetes patients | Active comparator | Oral glucose tolerance test and biopsies Receives: Other: Oral glucose tolerance test |
| Healthy control subjects | Active comparator | Oral glucose tolerance test and biopsies Receives: Other: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
gut-derived glucagon
The primary objective is to investigate mucosal biopsies from specific regions of the upper gastrointestinal tract
Measured: 1 year
Secondary outcomes (1)
Oral glucose tolerance test
Glucose metabolism - hormones, insulin, glucagon, glp-1
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start27 Apr 2017
- Primary completion3 Dec 2017
- Study completion3 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies 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
- 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
- Investigators
- Filip Knop, MD, PhD, Study director, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181191
- Sponsor's protocol ID
- UHG-CFD-PX-BIOPSY
- Status last verified
- Sep 2019
- First submitted
- 6 Jun 2017
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anatomical Location, Cellular Origin and Molecular Basis of Gut-derived Glucagon Secretion
- ClinicalTrials.gov ID
- NCT03181191
- Acronym / sponsor ID
- UHG-CFD-PX-BIOPSY
- Conditions
- Glucose Metabolism Disorders
- 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
- 27 Apr 2017 (actual)
- Primary completion
- 3 Dec 2017 (actual)
- Study completion
- 3 Dec 2017 (actual)
- First posted
- 8 Jun 2017 (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.
Delineation of the anatomical location, cellular origin and molecular basis of gut-derived glucagon secretion
Detailed description
Aim: to delineate the anatomical origin, the molecular structure and precursors, the regulation and the (patho-) physiological implications of gut-derived glucagon.
Eight totally pancreatectomised patients, eight type 2 diabetes patients and eight healthy controls (age 18-80, BMI <30) with normal kidney and liver parameters and hgb> 6.5 - will be included. The participants will each undergo one screening day and one study day including a gastroduodenoscopy. Multiple biopsies will be taken at several predefined locations in the upper gastrointestinal tract. These biopsies will be analysed with different techniques including immunohistochemical staining, quantitative polymerase chain reaction (qPCR-) analyses and more to search for glucagon. After the last biopsy has been collected, 50 g of glucose dissolved in 100 ml water is infused through the enteroscope into the most proximal part of the small intestine. Hereafter blood samples for glucagon and gut hormone analyses will be collected 15, 30 and 45 min after the glucose infusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Totally pancreatectomised patients | Active comparator | Other: Oral glucose tolerance testOral glucose tolerance test and biopsies |
| Type 2 diabetes patients | Active comparator | Other: Oral glucose tolerance testOral glucose tolerance test and biopsies |
| Healthy control subjects | Active comparator | Other: Oral glucose tolerance testOral glucose tolerance test and biopsies |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- normal kidney function, normal liver function, normal hemoglobin levels
Key exclusion criteria (1 listed)
- diabetes type 1, first degree relatives with type 2 diabetes
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 testOral glucose tolerance test and biopsies | Other | Healthy control subjects, Totally pancreatectomised patients, Type 2 diabetes patients |
Primary outcome
gut-derived glucagon
Time frame: 1 year
The primary objective is to investigate mucosal biopsies from specific regions of the upper gastrointestinal tract
1 secondary outcome
Oral glucose tolerance test
Time frame: 45 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 4 Sep 2019.
- 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.
Filip Knop, MD, PhD study director
University Hospital, Gentofte, Copenhagen
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 in people with Glucose Metabolism Disorders, 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 1 inclusion and 1 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 4 Sep 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?
gut-derived glucagon (time frame: 1 year). 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 4 Sep 2019.