Bariatric SurgeryNCT04055025
Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin
A study testing Ghrelin in people with Bariatric Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Our hypothesis is that decreased concentration of ghrelin after LSG is important for the decreased appetite and food intake postoperatively. We therefore expect infusion of ghrelin will increase an ad libitum food intake after LSG. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Ghrelin
- 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
- 28 Feb 2020to 20 May 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The Danish national inclusion criteria for bariatric surgery
- Signed written informed consent
- Fasting plasma glucose <6.1 mmol/l
Who cannot join
- Pregnancy or breastfeeding.
- Hemoglobin <6.5 mM
- Newly emerged serious disease
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Endocrinology, Hvidovre University Hospital
Copenhagen, Hvidovre, 2650
About this study
Our hypothesis is that decreased concentration of ghrelin after LSG is important for the decreased appetite and food intake postoperatively. We therefore expect infusion of ghrelin will increase an ad libitum food intake after LSG. We also expect that a decreased postprandial concentration of ghrelin after LSG play a role for increased insulin secretion and decreased postprandial plasma glucose concentrations after surgery.
Read the detailed description
Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are to bariatric procedure. After both procedures, a changed secretion of hormones from the gastrointestinal tract is believed to affect appetite and glucose metabolism. Studies have shown that after LRYGB, there is a significant increased secretion of GLP-1 and PYY. In contrast, a decreased secretion of ghrelin is a characteristic finding after LSG opposite post-LRYGB, where secretion of ghrelin is reported to be increased, decreased or unchanged. Ghrelin is primarily secreted from the gastric mucosa in the fasting state and decreases in response to food intake. Ghrelin stimulates food intake through appetite-regulating centers in the hypothalamus. Administration of exogenous ghrelin has been reported to stimulate appetite. In addition, ghrelin has recently been suggested also to affect glucose metabolism by inhibition of glucose-stimulated insulin secretion. Therefore the markedly decreased secretion of ghrelin could be of particular important for the decreased appetite and improved glucose tolerance seen after LSG.
- Conditions
- Bariatric Surgery
- Being tested
- Placebo, Ghrelin
- Keywords
- Ghrelin, Sleeve gastrectomy, Laparoscopic sleeve gastrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Four-hour liquid solid meal tests and a subsequent ad libitum meal during saline infusion.
GhrelinOther
Four-hour liquid solid meal tests and a subsequent ad libitum meal during acyl-ghrelin infusion.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy operated patients | Other | Six test days in a randomized, patient-blinded, cross-over design Receives: Other: Placebo; Other: Ghrelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum
Ad libitum food intake (gram) with and without infusion of ghrelin at 3 months after LSG surgery
Measured: 240 minutes
Secondary outcomes (2)
Ad libitum
Ad libitum food intake (gram) with and without ghrelin infusion before surgery.
Measured: 240 minutes
Ghrelin
Plasma concentration profile of ghrelin (AUC) before and after LSG.
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 posted13 Aug 2019
- Study start28 Feb 2020
- Primary completion12 May 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- Investigators
- Nora Hedbäck, MD, Principal investigator, Department of Endocrinology, Hvidovre University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055025
- Sponsor's protocol ID
- H-19010763
- Status last verified
- Feb 2024
- First submitted
- 7 Aug 2019
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin
- ClinicalTrials.gov ID
- NCT04055025
- Acronym / sponsor ID
- H-19010763
- Conditions
- Bariatric Surgery
- Keywords
- Ghrelin, Sleeve gastrectomy, Laparoscopic sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 13 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.
Our hypothesis is that decreased concentration of ghrelin after LSG is important for the decreased appetite and food intake postoperatively. We therefore expect infusion of ghrelin will increase an ad libitum food intake after LSG. We also expect that a decreased postprandial concentration of ghrelin after LSG play a role for increased insulin secretion and decreased postprandial plasma glucose concentrations after surgery.
Detailed description
Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are to bariatric procedure. After both procedures, a changed secretion of hormones from the gastrointestinal tract is believed to affect appetite and glucose metabolism. Studies have shown that after LRYGB, there is a significant increased secretion of GLP-1 and PYY. In contrast, a decreased secretion of ghrelin is a characteristic finding after LSG opposite post-LRYGB, where secretion of ghrelin is reported to be increased, decreased or unchanged. Ghrelin is primarily secreted from the gastric mucosa in the fasting state and decreases in response to food intake. Ghrelin stimulates food intake through appetite-regulating centers in the hypothalamus. Administration of exogenous ghrelin has been reported to stimulate appetite. In addition, ghrelin has recently been suggested also to affect glucose metabolism by inhibition of glucose-stimulated insulin secretion. Therefore the markedly decreased secretion of ghrelin could be of particular important for the decreased appetite and improved glucose tolerance seen after LSG.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy operated patients | Other | Other: Placebo, Other: GhrelinSix test days in a randomized, patient-blinded, cross-over design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The Danish national inclusion criteria for bariatric surgery
- Signed written informed consent
- Fasting plasma glucose <6.1 mmol/l
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding.
- Hemoglobin <6.5 mM
- Newly emerged serious 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 |
|---|---|---|
| PlaceboFour-hour liquid solid meal tests and a subsequent ad libitum meal during saline infusion. | Other | Sleeve gastrectomy operated patients |
| GhrelinFour-hour liquid solid meal tests and a subsequent ad libitum meal during acyl-ghrelin infusion. | Other | Sleeve gastrectomy operated patients |
Primary outcome
Ad libitum
Time frame: 240 minutes
Ad libitum food intake (gram) with and without infusion of ghrelin at 3 months after LSG surgery
2 secondary outcomes
Ad libitum
Time frame: 240 minutes
Ghrelin
Time frame: 240 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 28 Feb 2024.
- 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.
Nora Hedbäck, MD principal investigator
Department of Endocrinology, Hvidovre University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ghrelin in people with Bariatric Surgery, 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 3 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
Ad libitum (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 28 Feb 2024.