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ObesityNCT05667558

Assessment of the Clinical Condition and Way of Nutrition Patients Before and After Sleeve Gastrectomy

An observational study of Obesity, run by Medical University of Bialystok at 1 site in Poland.

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

Conservative treatment of patients with morbid obesity is inefficient, which is why surgical treatment is necessary. Although bariatric treatment is associated with the occurrence of complications resulting from the procedure or from nutritional insufficiencies, it leads to significant body mass reduction and… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Obesity
How many people
30 participants
Where
1 sitePoland
Study dates
30 Nov 2017to 31 Dec 2018
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 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: The study included 30 obese patients (15 women and 15 man) who met the criteria for beaing included in the study and who did not possess excusion criteria.inclusion criteria

Who may be able to join

  • women and men aged 18-64
  • BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with comorbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease

Who cannot join

  • pregnancy
  • gastrointestinal cancers
  • cardiorespiratory failure

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Medical University of Bialystok

    Bialystok, 15-089

Other trials in Poland

About this study

Official title: Assessment of Intake of Energy and Selected Nutrients, Nutritional Status, Body Composition and Biochemical Parameters of Obese Patients Before and After Bariatric Surgery

Conservative treatment of patients with morbid obesity is inefficient, which is why surgical treatment is necessary. Although bariatric treatment is associated with the occurrence of complications resulting from the procedure or from nutritional insufficiencies, it leads to significant body mass reduction and metabolic improvement of obese patients.

The aim of the study was to determine the clinical condition of obese patients after laparoscopic sleeve gastrectomy ( LSG) in terms of nutritional status, metabolic disorders and way of nutrition.

The study conduced 4 visits: preliminary visit (1 day before the surgery) and control visits (1, 3 and 6 months after the surgery). Based on the inclusion and exclusion criteria the observational study was conducted among 30 participants (15 women and 15 men).

Conditions
Obesity
Keywords
bariatric surgery, nutrition, body composition, nutritional status, obesity, laparoscopic sleeve gastrectomy
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05667558
Study groupRoleWhat they receive
Study grupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in anthropometric measurements during the 6 months after surgery

    Body weight in kilograms was measured using a scale with stadiometer. Body height in meters was measured using a scale with stadiometer. Body weight and height were used to calculate BMI (Body Mass Index) in kilograms divided by square metres.

    Hip circumference in centimeters was measured at the greater trochanters at the widest part of the hips. Waist circumference in centimeters was measured at the uppermost lateral border of the hip crest.

    Measured: before and 1,3 and 6 months after LSG

  2. Changes in percentage of excess weight loss during the 6 months after surgery

    Percentage of excess weight loss (%EWL) was calculated using the formula:

    %EWL = (preoperative weight - current weight)/(preoperative weight - ideal weight) × 100.

    Ideal body weight was calculated using Lorentz formula.

    Measured: 1, 3 and 6 months after LSG

  3. Changes in body composition during the 6 months after surgery

    Body composition was assessed four times (before and 1,3 and 6 months after LSG). Body composition parameters (fat mass in kilograms, percentage of body fat, fat free mass in kilograms, percentage of fat free mass, total body water in liters, percentage of total body water) was determined using the bioelectrical impedance method (BioScan 920-2 body composition analyzer, Maltron International Ltd., United Kingdom)

    Measured: before and 1,3 and 6 months after LSG

  4. Changes in energy and selected nutrients intake during the 6 months after surgery

    The intake of energy and selected nutrients was assessed four times (before and 1,3 and 6 months after LSG). A 3-day nutrition interview was collected. The supply of energy, protein, fat (including fatty acids), carbohydrates, dietary fibre, vitamins and minerals in the usual diet was assessed.

    Measured: before and 1,3 and 6 months after LSG

  5. Changes in blood biochemical parameters of patients during the 6 months after surgery.

    The biochemical parameters of the patient's blood were assessed four times (before and 1,3 and 6 months after LSG). Laboratory tests were performer to determine the following serum levels: fasting glucose, fasting insulin,total cholesterol, LDL cholesterol fraction, HDL cholesterol fraction, triglycerides and aminotransferases: alanine (ALT) and aspartate (AST), complete blood count.

    The HOMA-IR (homeostasis model assessment of insulin resistance) index was calculated according to the formula: [fasting insulin (mIU/l) x fasting glucose (mg/dl)] / 405

    Measured: before and 1,3 and 6 months after LSG

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study start30 Nov 2017
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

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 only
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05667558
Sponsor's protocol ID
N/ST/MN/18/001/3316
Status last verified
Nov 2022
First submitted
1 Dec 2022
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chang SH, Stoll CR, Song J, Varela JE, Eagon CJ, Colditz GA. The effectiveness and risks of bariatric surgery: an updated systematic review and meta-analysis, 2003-2012. JAMA Surg. 2014 Mar;149(3):275-87. doi: 10.1001/jamasurg.2013.3654.

    PubMed 24352617

  • Al-Mutawa A, Anderson AK, Alsabah S, Al-Mutawa M. Nutritional Status of Bariatric Surgery Candidates. Nutrients. 2018 Jan 11;10(1):67. doi: 10.3390/nu10010067.

    PubMed 29324643

  • Sherf Dagan S, Zelber-Sagi S, Webb M, Keidar A, Raziel A, Sakran N, Goitein D, Shibolet O. Nutritional Status Prior to Laparoscopic Sleeve Gastrectomy Surgery. Obes Surg. 2016 Sep;26(9):2119-2126. doi: 10.1007/s11695-016-2064-9.

    PubMed 26797718

  • Batar N, Pulat Demir H, Bayram HM. Assessment of nutritional status, body composition and blood biochemical parameters of patients following sleeve gastrectomy: 6 months follow up. Clin Nutr ESPEN. 2021 Jun;43:184-190. doi: 10.1016/j.clnesp.2021.04.016. Epub 2021 Apr 27.

    PubMed 34024512

  • Sherf Dagan S, Tovim TB, Keidar A, Raziel A, Shibolet O, Zelber-Sagi S. Inadequate protein intake after laparoscopic sleeve gastrectomy surgery is associated with a greater fat free mass loss. Surg Obes Relat Dis. 2017 Jan;13(1):101-109. doi: 10.1016/j.soard.2016.05.026. Epub 2016 Jun 2.

    PubMed 27521254

  • Dulloo AG, Jacquet J, Miles-Chan JL, Schutz Y. Passive and active roles of fat-free mass in the control of energy intake and body composition regulation. Eur J Clin Nutr. 2017 Mar;71(3):353-357. doi: 10.1038/ejcn.2016.256. Epub 2016 Dec 14.

    PubMed 27966570

  • Friedrich AE, Damms-Machado A, Meile T, Scheuing N, Stingel K, Basrai M, Kuper MA, Kramer KM, Konigsrainer A, Bischoff SC. Laparoscopic sleeve gastrectomy compared to a multidisciplinary weight loss program for obesity--effects on body composition and protein status. Obes Surg. 2013 Dec;23(12):1957-65. doi: 10.1007/s11695-013-1036-6.

    PubMed 23856991

  • Hopkins M, Finlayson G, Duarte C, Whybrow S, Ritz P, Horgan GW, Blundell JE, Stubbs RJ. Modelling the associations between fat-free mass, resting metabolic rate and energy intake in the context of total energy balance. Int J Obes (Lond). 2016 Feb;40(2):312-8. doi: 10.1038/ijo.2015.155. Epub 2015 Aug 17.

    PubMed 26278004

  • Fuchs T, Loureiro M, Both GH, Skraba HH, Costa-Casagrande TA. THE ROLE OF THE SLEEVE GASTRECTOMY AND THE MANAGEMENT OF TYPE 2 DIABETES. Arq Bras Cir Dig. 2017 Oct-Dec;30(4):283-286. doi: 10.1590/0102-6720201700040013.

    PubMed 29340555

  • Yip S, Plank LD, Murphy R. Gastric bypass and sleeve gastrectomy for type 2 diabetes: a systematic review and meta-analysis of outcomes. Obes Surg. 2013 Dec;23(12):1994-2003. doi: 10.1007/s11695-013-1030-z.

    PubMed 23955521

  • Milone M, Lupoli R, Maietta P, Di Minno A, Bianco P, Ambrosino P, Coretti G, Milone F, Di Minno MN, Musella M. Lipid profile changes in patients undergoing bariatric surgery: a comparative study between sleeve gastrectomy and mini-gastric bypass. Int J Surg. 2015 Feb;14:28-32. doi: 10.1016/j.ijsu.2014.12.025. Epub 2015 Jan 7.

    PubMed 25576760

  • Bower G, Toma T, Harling L, Jiao LR, Efthimiou E, Darzi A, Athanasiou T, Ashrafian H. Bariatric Surgery and Non-Alcoholic Fatty Liver Disease: a Systematic Review of Liver Biochemistry and Histology. Obes Surg. 2015 Dec;25(12):2280-9. doi: 10.1007/s11695-015-1691-x.

    PubMed 25917981

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by Medical University of Bialystok at 1 site in Poland.

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 2 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 Dec 2022. 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 Poland. 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?

Changes in anthropometric measurements during the 6 months after surgery (time frame: before and 1,3 and 6 months after LSG). The study lists 5 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 NCT05667558, which also lists 12 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 28 Dec 2022.

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