Endoscopic Sleeve GastroplastyNCT04452786
Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
A study testing Endoscopic sleeve gastroplasty and Laparoscopic sleeve gastrectomy in people with Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, Gut Hormones
- What is being tested?
- Endoscopic sleeve gastroplasty and Laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Jun 2020to Apr 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
- HbA1c < 48 mmol/mol before surgery, and no history of diabetes
- HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion
- BMI<45
Who cannot join
- Hemoglobin < 6.5 mmol/l at inclusion
- Pregnancy or breast feeding
- Medication affecting the planned examinations
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
About this study
The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).
- Conditions
- Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, Gut Hormones, Glucose Metabolism Disorders
- Being tested
- Endoscopic sleeve gastroplasty, Laparoscopic sleeve gastrectomy
- 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.
Endoscopic sleeve gastroplastyProcedure or surgery
Four-hour solid mixed meal test
Laparoscopic sleeve gastrectomyProcedure or surgery
Four-hour solid mixed meal test
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic sleeve gastroplasity operated patients | Other | Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery Receives: Procedure: Endoscopic sleeve gastroplasty |
| Laparoscopic sleeve gastrectomy operated patients | Other | Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery Receives: Procedure: Laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ghrelin (pg/ml)
Changes in ghrelin after a solid meal test compared before and after surgery
Measured: 240 minutes
Secondary outcomes (1)
Changes in gut hormone response before and after sugery (pmol/L)
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start5 Jun 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: Lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Sleeve GastroplastyStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nora Elisabeth Hedbäck, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452786
- Sponsor's protocol ID
- H-19012015
- Status last verified
- Aug 2021
- First submitted
- 19 Jun 2020
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
- ClinicalTrials.gov ID
- NCT04452786
- Acronym / sponsor ID
- H-19012015
- Conditions
- Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, Gut Hormones, Glucose Metabolism Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 30 Jun 2020 (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 investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic sleeve gastroplasity operated patients | Other | Procedure: Endoscopic sleeve gastroplastyFour test days, two days before surgery, one test day three months after surgery and one test day one year after surgery |
| Laparoscopic sleeve gastrectomy operated patients | Other | Procedure: Laparoscopic sleeve gastrectomyFour test days, two days before surgery, one test day three months after surgery and one test day one year after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
- HbA1c < 48 mmol/mol before surgery, and no history of diabetes
- HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion
- BMI<45
Key exclusion criteria (3 listed)
- Hemoglobin < 6.5 mmol/l at inclusion
- Pregnancy or breast feeding
- Medication affecting the planned examinations
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 |
|---|---|---|
| Endoscopic sleeve gastroplastyFour-hour solid mixed meal test | Procedure or surgery | Endoscopic sleeve gastroplasity operated patients |
| Laparoscopic sleeve gastrectomyFour-hour solid mixed meal test | Procedure or surgery | Laparoscopic sleeve gastrectomy operated patients |
Primary outcome
Changes in ghrelin (pg/ml)
Time frame: 240 minutes
Changes in ghrelin after a solid meal test compared before and after surgery
1 secondary outcome
Changes in gut hormone response before and after sugery (pmol/L)
Time frame: 240 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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 Endoscopic sleeve gastroplasty and Laparoscopic sleeve gastrectomy in people with Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy, run by Hvidovre University Hospital 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 5 Sep 2021. 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 was withdrawn before enrolling participants, so there are no results.
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 ghrelin (pg/ml) (time frame: 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 5 Sep 2021.