Obesity, MorbidNCT03046186
Physiological Effects of Gastric Sleeve Operation
An observational study of Obesity, Morbid and Bariatric Surgery, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery
- What is being tested?
- Mixed meal test with double tracer technique
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2016to Jun 2017
- Phase
- Observational
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients, who have undergone Roux-en-Y gastric bypass OR gastric sleeve operation > 12 month prior to inclusion. Matched un-operated control subjects.
Who may be able to join
- Uncomplicated RYGB or SG > 12 month prior to inclusion
- Weight stable (+/- 3 month the last month)
- Written informed consent
- Written informed consent
Who cannot join
- Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
- Pregnancy and/or breastfeeding
- Inadequately treated thyroid disease
- Serious heart or respiratory illness
- Haemoglobin < 6,5 mM.
- Un-operated control group:
Show all 12Show fewer
- Prior RYGB, SG or complicated upper gastrointestinal surgery
- Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
- Pregnancy and/or breastfeeding
- Inadequately treated thyroid disease
- Serious heart or respiratory illness
- Haemoglobin < 6,5 mM.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Gastric Sleeve Operation on Absorption and Metabolism of Glucose and Protein as Well as Gut-hormonal Response - A Comparison With Roux-en-Y Gastric Bypass
After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.
- Conditions
- Obesity, Morbid, Bariatric Surgery
- Being tested
- Mixed meal test with double tracer technique
- Keywords
- Gastric sleeve, Gastric bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixed meal test with double tracer techniqueDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Gastric sleeve operated subjects | 12 patients who have undergone gastric sleeve operation >12 month prior to inclution. Receives: Diagnostic Test: Mixed meal test with double tracer technique | |
| Control Subjects | 12 Healthy un-operated control subjects matched to the gastric sleeve group in a one to one manner with respect to BMI, sex and age Receives: Diagnostic Test: Mixed meal test with double tracer technique | |
| Gastric bypass operated subjects | 12 patients, who have undergone Roux-en-Y gastric bypass >12 month prior to inclution, matched to the gastric sleeve group in a one to one manner with respect to pre-operative BMI, post-operative BMI, sex and age. Receives: Diagnostic Test: Mixed meal test with double tracer technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose absorption
Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON
Measured: 0 - 360 minutes
Protein absorption
Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON
Measured: 0 - 360 minutes
Secondary outcomes (12)
Glucose absorption
Between group difference in peak Ra of oral glucose comparing SG vs. RYGB
Measured: 0 - 360 minutes
Protein absorption
Between groups differences in peak Ra of oral aminoacid tracer comparing SG vs. RYGB
Measured: 0 - 360 minutes
Glucose kinetics
Between groups differences in AUC Ra of oral glucose tracer
Measured: 0 - 360 minutes
Protein kinetics
Between groups differences in AUC Ra of oral aminoacid tracer
Measured: 0 - 360 minutes
Insulin secretion
Between groups differences in iAUC of serum insulin and C-peptide
Measured: 0 - 240 minutes
Glucagon-like Peptide 1 (GLP-1) secretion
Between groups differences in iAUC of plasma concentration of GLP-1
Measured: 0 - 240 minutes
Glucose-dependent Insulinotropic Peptide (GIP)
Between groups differences in iAUC of plasma concentration of GIP
Measured: 0 - 240 minutes
Ghrelin secretion
Between groups differences in iAUC of plasma concentration of ghrelin
Measured: 0 - 240 minutes
Glucagon secretion
Between groups differences in iAUC of plasma cncentration of glucagon
Measured: 0-240 minutes
Peptide YY
Between groups differences in iAUC of plasma concentration of PYY
Measured: 0-240 minutes
Endogenous glucose production
Calculated via double tracer tecnique both in the fasting and post prandial state.
Measured: -120 - 360 minutes
Lipolysis
Between groups differences in Rate of Disappearance of glycerol tracer.
Measured: -120 - 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJun 2017
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 Obesity, MorbidStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Principal investigator, Maria Saur Svane, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046186
- Sponsor's protocol ID
- MS-SGRYGB-15
- Status last verified
- Nov 2020
- First submitted
- 6 Feb 2017
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Svane MS, Bojsen-Moller KN, Martinussen C, Dirksen C, Madsen JL, Reitelseder S, Holm L, Rehfeld JF, Kristiansen VB, van Hall G, Holst JJ, Madsbad S. Postprandial Nutrient Handling and Gastrointestinal Hormone Secretion After Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy. Gastroenterology. 2019 May;156(6):1627-1641.e1. doi: 10.1053/j.gastro.2019.01.262. Epub 2019 Feb 8.
PubMed 30742833
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gastric Sleeve Operation on Absorption and Metabolism of Glucose and Protein as Well as Gut-hormonal Response - A Comparison With Roux-en-Y Gastric Bypass
- ClinicalTrials.gov ID
- NCT03046186
- Acronym / sponsor ID
- MS-SGRYGB-15
- Conditions
- Obesity, Morbid, Bariatric Surgery
- Keywords
- Gastric sleeve, Gastric bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 8 Feb 2017 (estimated)
- 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.
After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gastric sleeve operated subjects | – | Diagnostic Test: Mixed meal test with double tracer technique12 patients who have undergone gastric sleeve operation >12 month prior to inclution. |
| Control Subjects | – | Diagnostic Test: Mixed meal test with double tracer technique12 Healthy un-operated control subjects matched to the gastric sleeve group in a one to one manner with respect to BMI, sex and age |
| Gastric bypass operated subjects | – | Diagnostic Test: Mixed meal test with double tracer technique12 patients, who have undergone Roux-en-Y gastric bypass >12 month prior to inclution, matched to the gastric sleeve group in a one to one manner with respect to pre-operative BMI, post-operative BMI, sex and age. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients, who have undergone Roux-en-Y gastric bypass OR gastric sleeve operation > 12 month prior to inclusion. Matched un-operated control subjects.
Key inclusion criteria (4 listed)
- Uncomplicated RYGB or SG > 12 month prior to inclusion
- Weight stable (+/- 3 month the last month)
- Written informed consent
- Written informed consent
Key exclusion criteria (12 listed)
- Diabetes (HbA1c>48 or Fasting plasma-glucose>6.1 mM)
- Pregnancy and/or breastfeeding
- Inadequately treated thyroid disease
- Serious heart or respiratory illness
- Haemoglobin < 6,5 mM.
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 |
|---|---|---|
| Mixed meal test with double tracer technique | Diagnostic test | Control Subjects, Gastric bypass operated subjects, Gastric sleeve operated subjects |
Primary outcome
Glucose absorption
Time frame: 0 - 360 minutes
Between groups difference in peak Rate of appearance (Ra) of oral glucose tracer SG vs. CON
Protein absorption
Time frame: 0 - 360 minutes
Between groups difference in peak Ra of oral aminoacid tracer SG vs. CON
12 secondary outcomes
Glucose absorption
Time frame: 0 - 360 minutes
Protein absorption
Time frame: 0 - 360 minutes
Glucose kinetics
Time frame: 0 - 360 minutes
Protein kinetics
Time frame: 0 - 360 minutes
Insulin secretion
Time frame: 0 - 240 minutes
Glucagon-like Peptide 1 (GLP-1) secretion
Time frame: 0 - 240 minutes
Glucose-dependent Insulinotropic Peptide (GIP)
Time frame: 0 - 240 minutes
Ghrelin secretion
Time frame: 0 - 240 minutes
Glucagon secretion
Time frame: 0-240 minutes
Peptide YY
Time frame: 0-240 minutes
Endogenous glucose production
Time frame: -120 - 360 minutes
Lipolysis
Time frame: -120 - 360
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 30 Nov 2020.
- Derived from this study: PubMed 30742833Svane MS, Bojsen-Moller KN, Martinussen C, Dirksen C, Madsen JL, Reitelseder S, Holm L, Rehfeld JF, Kristiansen VB, van Hall G, Holst JJ, Madsbad S. Postprandial Nutrient Handling and Gastrointestinal Hormone Secretion After Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy. Gastroenterology. 2019 May;156(6):1627-1641.e1. doi: 10.1053/j.gastro.2019.01.262. Epub 2019 Feb 8.
- 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.
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?
An observational study of Obesity, Morbid and 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 4 inclusion and 12 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 30 Nov 2020. 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?
Glucose absorption (time frame: 0 - 360 minutes). The study lists 2 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 NCT03046186, 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 30 Nov 2020.