NCT02893891

Brief Summary

Literature data clearly demonstrate that treatment of obese patients is very expensive, long and achieve weight loss may not be permanent, and regardless of whether the treatment dominated diet therapy, physical activity, or pharmacotherapy. Experience of the last decade has shown that after surgical interventional treatment of obesity occurs not only long-term (10 years and over) weight loss of 35-40%, but also an important endocrine changes. In recent years, it was discovered a number of signaling molecules produced by adipose tissue, whose physiological significance beyond the general metabolic aspects organism. The fat is therefore currently understood as an endocrine organ whose hormones modulate the function of many systems, including the skeleton. These hormones include the adipokines that modulate metabolism skeleton as at tissue level (Leptin, Adiponectin) and indirectly - by activation of neurohumoral hypothalamic centers - Leptin. Studying endocrine interactions between adipose tissue and bone is a highly topical issue. This mutual communication is a homeostatic feedback system in which adipokines and molecules secreted by osteoblasts and osteoclasts are the connecting link active axes fat - bone tissue. However, the mechanisms of this axis remain largely unknown.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

March 1, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

5.6 years

First QC Date

February 24, 2016

Last Update Submit

March 22, 2018

Conditions

Grade III ObesityType 2 Diabetes Mellitus

Keywords

ObesityBariatric medicineSleeve gastric resectionGastric plicationIntragastric ballonBody compositionAdipokinesGhrelinBone mineral densityQuality of life

Outcome Measures

Primary Outcomes (5)

  • Changes in serum levels of adipose tissue hormones

    To analyze the dynamics of changes in serum levels of adipose tissue hormones (Leptin, Adiponectin) in adults after bariatric treatment of malignant obesity (BMI\> 35). Points of measurements: before the planned intervention and then in intervals of 3, 6, 12, and 18 months after procedure.

    18 months

  • Changes in serum levels of lipids

    To analyze the dynamics of changes in serum levels of lipids in adults after bariatric treatment of malignant obesity (BMI\> 35). In the study, serum concentrations of the following lipids will be measured: tricylglycerols, total cholesterol, high-density lipoprotein, low-density lipoprotein cholesterol, Apo D and Apo E. The measurements will be performed before the planned intervention and then in intervals at 3, 6, 12, and 18 months after the procedure. The results will be presented in respective units (mmol/L, mg/dL, etc.).

    18 months

  • Changes in serum levels of osteomarkers

    To analyze the dynamics of changes in serum levels of usual panel of osteomarkers in adults after bariatric treatment of malignant obesity (BMI\> 35). The following serum levels markers of bone resorption and formation will be assessed: CTx, P1NP, ALP, RANKL, FGF 23, Osteocalcin, Osteopontin and vitamin D2 and D3. The measurements will be performed before the planned intervention and then in intervals at 3, 6, 12, and 18 months after the procedure. The results will be presented in respective units (mmol/L, mg/dL, etc.).

    18 months

  • IWQOL Questionnaire evaluation

    Evaluation of effects of different types of bariatric interventions on quality of life will be performed by using the IWQOL questionnaire. Improvement from baseline quality of life as measured by standardized IWQOL patient questionnaire (http://www.qualityoflifeconsulting.com/iwqol-lite.html) intended to measure the patient health status.

    18 months

  • SF-36 Questionnaire evaluation

    Evaluation of effects of different types of bariatric interventions on quality of life will be performed using the SF-36 questionnaire. Improvement from baseline quality of life as measured by standardized SF-36 patient questionnaire intended to measure the patient health status.

    18 months

Secondary Outcomes (2)

  • Long-term weight reduction assessment in kgs

    18 months

  • Effectiveness evaluation

    18 months

Study Arms (3)

Laparoscopic sleeve gastrectomy

ACTIVE COMPARATOR

Patients undergoing bariatric surgery procedure of laparoscopic sleeve gastrectomy.

Procedure: Laparoscopic sleeve gastrectomy

Laparoscopic gastric plication

ACTIVE COMPARATOR

Patients undergoing bariatric surgery procedure of laparoscopic gastric plication.

Procedure: Laparoscopic gastric plication

Intragastric balloon

ACTIVE COMPARATOR

Patients undergoing bariatric surgery procedure with intragastric balloon implantation.

Procedure: Intragastric balloonDevice: Intragastric balloon implantation

Interventions

Laparoscopic sleeve gastrectomyPROCEDURE

Sleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat.

Laparoscopic sleeve gastrectomy
Laparoscopic gastric plicationPROCEDURE

Laparoscopic gastric plication involves sewing one or more large folds in the stomach. During the laparoscopic gastric plication, the stomach volume is reduced about 70%, which makes the stomach able to hold less and helps the patient eat less.

Laparoscopic gastric plication
Intragastric balloonPROCEDURE

The introduction of the balloon is non-invasive as it is inserted endoscopically (down the oesophagus). The balloon is then filled inside the stomach with a dyed physiological solution, which reduces the volume of the stomach.

Intragastric balloon
Intragastric balloon implantationDEVICE

Intragastric balloons (End-Ball, Medsil) will be implanted in the patients with morbid obesity.

Intragastric balloon

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • History of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities)

You may not qualify if:

  • Thyroid disease
  • Diseases of the digestive system associated with disorders of intestinal absorption
  • History of corticosteroid therapy in the past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vítkovice Hospital Ostrava

Ostrava, Moravian-Silesian Region, 703 00, Czechia

Location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Related Publications (14)

  • Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

    PMID: 11234459BACKGROUND

  • Suter M, Calmes JM, Paroz A, Giusti V. A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates. Obes Surg. 2006 Jul;16(7):829-35. doi: 10.1381/096089206777822359.

    PMID: 16839478BACKGROUND

  • Bose M, Olivan B, Teixeira J, Pi-Sunyer FX, Laferrere B. Do Incretins play a role in the remission of type 2 diabetes after gastric bypass surgery: What are the evidence? Obes Surg. 2009 Feb;19(2):217-229. doi: 10.1007/s11695-008-9696-3. Epub 2008 Sep 27.

    PMID: 18820978BACKGROUND

  • Buchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg. 2009 Dec;19(12):1605-11. doi: 10.1007/s11695-009-0014-5.

    PMID: 19885707BACKGROUND

  • Koerner A, Kratzsch J, Kiess W. Adipocytokines: leptin--the classical, resistin--the controversical, adiponectin--the promising, and more to come. Best Pract Res Clin Endocrinol Metab. 2005 Dec;19(4):525-46. doi: 10.1016/j.beem.2005.07.008.

    PMID: 16311215BACKGROUND

  • Magni P, Dozio E, Galliera E, Ruscica M, Corsi MM. Molecular aspects of adipokine-bone interactions. Curr Mol Med. 2010 Aug;10(6):522-32. doi: 10.2174/1566524011009060522.

    PMID: 20642443BACKGROUND

  • Pobeha P, Ukropec J, Skyba P, Ukropcova B, Joppa P, Kurdiova T, Javorsky M, Klimes I, Tkac I, Gasperikova D, Tkacova R. Relationship between osteoporosis and adipose tissue leptin and osteoprotegerin in patients with chronic obstructive pulmonary disease. Bone. 2011 May 1;48(5):1008-14. doi: 10.1016/j.bone.2011.02.017. Epub 2011 Mar 1.

    PMID: 21376149BACKGROUND

  • Boyce BF, Xing L. Functions of RANKL/RANK/OPG in bone modeling and remodeling. Arch Biochem Biophys. 2008 May 15;473(2):139-46. doi: 10.1016/j.abb.2008.03.018. Epub 2008 Mar 25.

    PMID: 18395508BACKGROUND

  • Makovey J, Naganathan V, Seibel M, Sambrook P. Gender differences in plasma ghrelin and its relations to body composition and bone - an opposite-sex twin study. Clin Endocrinol (Oxf). 2007 Apr;66(4):530-7. doi: 10.1111/j.1365-2265.2007.02768.x.

    PMID: 17371471BACKGROUND

  • Hamrick MW, Ferrari SL. Leptin and the sympathetic connection of fat to bone. Osteoporos Int. 2008 Jul;19(7):905-12. doi: 10.1007/s00198-007-0487-9. Epub 2007 Oct 9.

    PMID: 17924050BACKGROUND

  • Gomez-Ambrosi J, Rodriguez A, Catalan V, Fruhbeck G. The bone-adipose axis in obesity and weight loss. Obes Surg. 2008 Sep;18(9):1134-43. doi: 10.1007/s11695-008-9548-1. Epub 2008 Jun 19.

    PMID: 18563500BACKGROUND

  • Greco EA, Fornari R, Rossi F, Santiemma V, Prossomariti G, Annoscia C, Aversa A, Brama M, Marini M, Donini LM, Spera G, Lenzi A, Lubrano C, Migliaccio S. Is obesity protective for osteoporosis? Evaluation of bone mineral density in individuals with high body mass index. Int J Clin Pract. 2010 May;64(6):817-20. doi: 10.1111/j.1742-1241.2009.02301.x.

    PMID: 20518955BACKGROUND

  • Wucher H, Ciangura C, Poitou C, Czernichow S. Effects of weight loss on bone status after bariatric surgery: association between adipokines and bone markers. Obes Surg. 2008 Jan;18(1):58-65. doi: 10.1007/s11695-007-9258-0. Epub 2007 Dec 11.

    PMID: 18074189BACKGROUND

  • Buzga M, Svagera Z, Tomaskova H, Hauptman K, Holeczy P. Metabolic Effects of Sleeve Gastrectomy and Laparoscopic Greater Curvature Plication: an 18-Month Prospective, Observational, Open-Label Study. Obes Surg. 2017 Dec;27(12):3258-3266. doi: 10.1007/s11695-017-2779-2.

    PMID: 28674838DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marek Bužga, MSc., Ph.D.

    Faculty of Medicine, Ostrava University, Ostrava

    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
SPONSOR

Study Record Dates

First Submitted

February 24, 2016

First Posted

September 9, 2016

Study Start

March 1, 2012

Primary Completion

October 1, 2017

Study Completion

December 1, 2017

Last Updated

March 26, 2018

Record last verified: 2018-03

Locations

CZ(2)