Morbid ObesityNCT03851874
Comparison of Gastric Bypass and Sleeve Gastrectomy in Metabolic and Cardiovascular Indices
A study testing Bariatric surgery in people with Morbid Obesity, run by National and Kapodistrian University of Athens.
Trial summary
Morbidly obese patients undergoing either Roux en Y gastric bypass or sleeve gastrectomy were examined preoperatively, 3, 6, and 12 months after surgery. On each occasion, anthropometric data were collected, resting metabolic rate was measured, and the patients underwent a panel of cardiovascular examinations (heart… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jan 2014
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >40 kg/m2
- Age between 18 and 65 years
- Proven failure to lose weight through non-surgical interventions
Who cannot join
- Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy)
- Patients' inability to adhere to postsurgical instructions
- Alcohol or other substance abuse
- Concurrent psychiatric illness
About this study
Official title: A Comparative Study of the Effects of Roux en Y Gastric Bypass and Sleeve Gastrectomy on Postprandial Gut Hormone Responses, Glycemia and Lipid Profile, Weight Loss, and Indices of Cardiovascular Risk
Morbidly obese patients undergoing either Roux en Y gastric bypass or sleeve gastrectomy were examined preoperatively, 3, 6, and 12 months after surgery. On each occasion, anthropometric data were collected, resting metabolic rate was measured, and the patients underwent a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). Following that, they consumed a test meal and completed visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same time points, blood samples were collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones.
- Conditions
- Morbid Obesity
- Being tested
- Bariatric surgery
- Keywords
- Bariatric surgery, gut peptides, weight loss, glycemia
- Medical subject headings
- Obesity, Morbid, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass bariatric surgery | Active comparator | Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity Receives: Procedure: Bariatric surgery |
| Sleeve gastrectomy bariatric surgery | Active comparator | Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial ghrelin responses
Change in the cumulative postprandial response for ghrelin
Measured: 3, 6, and 12 months
Change in postprandial GLP-1 responses
Change in the cumulative postprandial response for GLP-1
Measured: 3, 6, and 12 months
Change in postprandial PYY responses
Change in the cumulative postprandial response for PYY
Measured: 3, 6, and 12 months
Secondary outcomes (4)
Change in weight
Change in weight (percentage of weight lost through each procedure)
Measured: 3, 6, and 12 months
Change in postprandial glycemia
Change in the cumulative postprandial response for glucose
Measured: 3, 6, and 12 months
Change in postprandial insulinemia
Change in the cumulative postprandial response for insulin
Measured: 3, 6, and 12 months
Change in postprandial triglyceridemia
Change in the cumulative postprandial response for triglycerides
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study startOct 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Alexandros Kokkinos, National and Kapodistrian University of Athens
- Investigators
- Alexandros Kokkinos, MD, PhD, Principal investigator, First Department of Propaedeutic Medicine, NKUA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851874
- Sponsor's protocol ID
- Bariatric study
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 22 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holst JJ, Madsbad S. Mechanisms of surgical control of type 2 diabetes: GLP-1 is key factor. Surg Obes Relat Dis. 2016 Jul;12(6):1236-42. doi: 10.1016/j.soard.2016.02.033. Epub 2016 Mar 3.
PubMed 27313194Korner J, Bessler M, Inabnet W, Taveras C, Holst JJ. Exaggerated glucagon-like peptide-1 and blunted glucose-dependent insulinotropic peptide secretion are associated with Roux-en-Y gastric bypass but not adjustable gastric banding. Surg Obes Relat Dis. 2007 Nov-Dec;3(6):597-601. doi: 10.1016/j.soard.2007.08.004. Epub 2007 Oct 23.
PubMed 17936091Dimitriadis GK, Randeva MS, Miras AD. Potential Hormone Mechanisms of Bariatric Surgery. Curr Obes Rep. 2017 Sep;6(3):253-265. doi: 10.1007/s13679-017-0276-5.
PubMed 28780756Laferrere B, Swerdlow N, Bawa B, Arias S, Bose M, Olivan B, Teixeira J, McGinty J, Rother KI. Rise of oxyntomodulin in response to oral glucose after gastric bypass surgery in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):4072-6. doi: 10.1210/jc.2009-2767. Epub 2010 May 25.
PubMed 20501690Yousseif A, Emmanuel J, Karra E, Millet Q, Elkalaawy M, Jenkinson AD, Hashemi M, Adamo M, Finer N, Fiennes AG, Withers DJ, Batterham RL. Differential effects of laparoscopic sleeve gastrectomy and laparoscopic gastric bypass on appetite, circulating acyl-ghrelin, peptide YY3-36 and active GLP-1 levels in non-diabetic humans. Obes Surg. 2014 Feb;24(2):241-52. doi: 10.1007/s11695-013-1066-0.
PubMed 23996294Farey JE, Preda TC, Fisher OM, Levert-Mignon AJ, Stewart RL, Karsten E, Herbert BR, Swarbrick MM, Lord RV. Effect of Laparoscopic Sleeve Gastrectomy on Fasting Gastrointestinal, Pancreatic, and Adipose-Derived Hormones and on Non-Esterified Fatty Acids. Obes Surg. 2017 Feb;27(2):399-407. doi: 10.1007/s11695-016-2302-1.
PubMed 27465935Angelidi AM, Kokkinos A, Sanoudou D, Connelly MA, Alexandrou A, Mingrone G, Mantzoros CS. Early metabolomic, lipid and lipoprotein changes in response to medical and surgical therapeutic approaches to obesity. Metabolism. 2023 Jan;138:155346. doi: 10.1016/j.metabol.2022.155346. Epub 2022 Nov 12.
PubMed 36375643
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Effects of Roux en Y Gastric Bypass and Sleeve Gastrectomy on Postprandial Gut Hormone Responses, Glycemia and Lipid Profile, Weight Loss, and Indices of Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT03851874
- Acronym / sponsor ID
- Bariatric study
- Conditions
- Morbid Obesity
- Keywords
- Bariatric surgery, gut peptides, weight loss, glycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Oct 2011 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 22 Feb 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.
Morbidly obese patients undergoing either Roux en Y gastric bypass or sleeve gastrectomy were examined preoperatively, 3, 6, and 12 months after surgery. On each occasion, anthropometric data were collected, resting metabolic rate was measured, and the patients underwent a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). Following that, they consumed a test meal and completed visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same time points, blood samples were collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass bariatric surgery | Active comparator | Procedure: Bariatric surgeryPatients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity |
| Sleeve gastrectomy bariatric surgery | Active comparator | Procedure: Bariatric surgeryPatients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI >40 kg/m2
- Age between 18 and 65 years
- Proven failure to lose weight through non-surgical interventions
Key exclusion criteria (4 listed)
- Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy)
- Patients' inability to adhere to postsurgical instructions
- Alcohol or other substance abuse
- Concurrent psychiatric illness
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 |
|---|---|---|
| Bariatric surgeryBariatric surgery | Procedure or surgery | Gastric bypass bariatric surgery, Sleeve gastrectomy bariatric surgery |
Primary outcome
Change in postprandial ghrelin responses
Time frame: 3, 6, and 12 months
Change in the cumulative postprandial response for ghrelin
Change in postprandial GLP-1 responses
Time frame: 3, 6, and 12 months
Change in the cumulative postprandial response for GLP-1
Change in postprandial PYY responses
Time frame: 3, 6, and 12 months
Change in the cumulative postprandial response for PYY
4 secondary outcomes
Change in weight
Time frame: 3, 6, and 12 months
Change in postprandial glycemia
Time frame: 3, 6, and 12 months
Change in postprandial insulinemia
Time frame: 3, 6, and 12 months
Change in postprandial triglyceridemia
Time frame: 3, 6, and 12 months
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 22 Feb 2019.
- Background: PubMed 27313194Holst JJ, Madsbad S. Mechanisms of surgical control of type 2 diabetes: GLP-1 is key factor. Surg Obes Relat Dis. 2016 Jul;12(6):1236-42. doi: 10.1016/j.soard.2016.02.033. Epub 2016 Mar 3.
- Background: PubMed 17936091Korner J, Bessler M, Inabnet W, Taveras C, Holst JJ. Exaggerated glucagon-like peptide-1 and blunted glucose-dependent insulinotropic peptide secretion are associated with Roux-en-Y gastric bypass but not adjustable gastric banding. Surg Obes Relat Dis. 2007 Nov-Dec;3(6):597-601. doi: 10.1016/j.soard.2007.08.004. Epub 2007 Oct 23.
- Background: PubMed 28780756Dimitriadis GK, Randeva MS, Miras AD. Potential Hormone Mechanisms of Bariatric Surgery. Curr Obes Rep. 2017 Sep;6(3):253-265. doi: 10.1007/s13679-017-0276-5.
- Background: PubMed 20501690Laferrere B, Swerdlow N, Bawa B, Arias S, Bose M, Olivan B, Teixeira J, McGinty J, Rother KI. Rise of oxyntomodulin in response to oral glucose after gastric bypass surgery in patients with type 2 diabetes. J Clin Endocrinol Metab. 2010 Aug;95(8):4072-6. doi: 10.1210/jc.2009-2767. Epub 2010 May 25.
- Background: PubMed 23996294Yousseif A, Emmanuel J, Karra E, Millet Q, Elkalaawy M, Jenkinson AD, Hashemi M, Adamo M, Finer N, Fiennes AG, Withers DJ, Batterham RL. Differential effects of laparoscopic sleeve gastrectomy and laparoscopic gastric bypass on appetite, circulating acyl-ghrelin, peptide YY3-36 and active GLP-1 levels in non-diabetic humans. Obes Surg. 2014 Feb;24(2):241-52. doi: 10.1007/s11695-013-1066-0.
- Background: PubMed 27465935Farey JE, Preda TC, Fisher OM, Levert-Mignon AJ, Stewart RL, Karsten E, Herbert BR, Swarbrick MM, Lord RV. Effect of Laparoscopic Sleeve Gastrectomy on Fasting Gastrointestinal, Pancreatic, and Adipose-Derived Hormones and on Non-Esterified Fatty Acids. Obes Surg. 2017 Feb;27(2):399-407. doi: 10.1007/s11695-016-2302-1.
- Derived from this study: PubMed 36375643Angelidi AM, Kokkinos A, Sanoudou D, Connelly MA, Alexandrou A, Mingrone G, Mantzoros CS. Early metabolomic, lipid and lipoprotein changes in response to medical and surgical therapeutic approaches to obesity. Metabolism. 2023 Jan;138:155346. doi: 10.1016/j.metabol.2022.155346. Epub 2022 Nov 12.
- 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.
Alexandros Kokkinos, MD, PhD principal investigator
First Department of Propaedeutic Medicine, NKUA
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery in people with Morbid Obesity, run by National and Kapodistrian University of Athens.
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 4 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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in postprandial ghrelin responses (time frame: 3, 6, and 12 months). The study lists 3 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 NCT03851874, which also lists 7 linked publications.
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 22 Feb 2019.