NCT03851874

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
Last Updated

February 22, 2019

Status Verified

February 1, 2019

Enrollment Period

2.3 years

First QC Date

February 21, 2019

Last Update Submit

February 21, 2019

Conditions

Morbid Obesity

Keywords

Bariatric surgery, gut peptides, weight loss, glycemia

Outcome Measures

Primary Outcomes (3)

  • Change in postprandial ghrelin responses

    Change in the cumulative postprandial response for ghrelin

    3, 6, and 12 months

  • Change in postprandial GLP-1 responses

    Change in the cumulative postprandial response for GLP-1

    3, 6, and 12 months

  • Change in postprandial PYY responses

    Change in the cumulative postprandial response for PYY

    3, 6, and 12 months

Secondary Outcomes (4)

  • Change in weight

    3, 6, and 12 months

  • Change in postprandial glycemia

    3, 6, and 12 months

  • Change in postprandial insulinemia

    3, 6, and 12 months

  • Change in postprandial triglyceridemia

    3, 6, and 12 months

Other Outcomes (4)

  • Change in baroreflex sensitivity

    3, 6, and 12 months

  • Change in heart rate variability

    3, 6, and 12 months

  • Change in aortic distensibility

    3, 6, and 12 months

  • +1 more other outcomes

Study Arms (2)

Gastric bypass bariatric surgery

ACTIVE COMPARATOR

Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity

Procedure: Bariatric surgery

Sleeve gastrectomy bariatric surgery

ACTIVE COMPARATOR

Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity

Procedure: Bariatric surgery

Interventions

Bariatric surgeryPROCEDURE

Bariatric surgery

Gastric bypass bariatric surgerySleeve gastrectomy bariatric surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>40 kg/m2
  • Age between 18 and 65 years
  • Proven failure to lose weight through non-surgical interventions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 27313194BACKGROUND

  • 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.

    PMID: 17936091BACKGROUND

  • 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.

    PMID: 28780756BACKGROUND

  • 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.

    PMID: 20501690BACKGROUND

  • 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.

    PMID: 23996294BACKGROUND

  • 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.

    PMID: 27465935BACKGROUND

  • 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.

    PMID: 36375643DERIVED

MeSH Terms

Conditions

Obesity, MorbidWeight Loss

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Alexandros Kokkinos, MD, PhD

    First Department of Propaedeutic Medicine, NKUA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor in Internal Medicine

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 22, 2019

Study Start

October 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

February 22, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share