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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 groups in NCT03851874
Study groupRoleWhat they receive
Gastric bypass bariatric surgeryActive comparatorPatients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity
Receives: Procedure: Bariatric surgery
Sleeve gastrectomy bariatric surgeryActive comparatorPatients 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.

  1. Change in postprandial ghrelin responses

    Change in the cumulative postprandial response for ghrelin

    Measured: 3, 6, and 12 months

  2. Change in postprandial GLP-1 responses

    Change in the cumulative postprandial response for GLP-1

    Measured: 3, 6, and 12 months

  3. Change in postprandial PYY responses

    Change in the cumulative postprandial response for PYY

    Measured: 3, 6, and 12 months

Secondary outcomes (4)

  1. Change in weight

    Change in weight (percentage of weight lost through each procedure)

    Measured: 3, 6, and 12 months

  2. Change in postprandial glycemia

    Change in the cumulative postprandial response for glucose

    Measured: 3, 6, and 12 months

  3. Change in postprandial insulinemia

    Change in the cumulative postprandial response for insulin

    Measured: 3, 6, and 12 months

  4. 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.

  1. First posted22 Feb 2019
  2. Study startOct 2011
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

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)
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 27313194

  • Korner 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 17936091

  • Dimitriadis 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 28780756

  • Laferrere 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 20501690

  • Yousseif 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 23996294

  • Farey 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 27465935

  • Angelidi 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

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.

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