Grade III ObesityNCT02893891
Metabolic Changes After Bariatric Surgery
A study testing Laparoscopic sleeve gastrectomy, Laparoscopic gastric plication and Intragastric balloon in people with Grade III Obesity and Type 2 Diabetes Mellitus, run by University Hospital Ostrava at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Grade III Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Laparoscopic sleeve gastrectomy, Laparoscopic gastric plication and Intragastric balloon
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesCzechia
- Study dates
- Mar 2012to Dec 2017
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities)
Who cannot join
- Thyroid disease
- Diseases of the digestive system associated with disorders of intestinal absorption
- History of corticosteroid therapy in the past 12 months
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Vítkovice Hospital Ostrava
Ostrava, Moravian-Silesian Region, 703 00
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 708 52
About this study
Official title: Metabolic Changes of Fat and Bone Tissue After Radical Bariatric Surgery
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.
Read the detailed description
Obesity is an important medical problem. The number of obese individuals is increasing continuously in response to various environmental and genetic factors. For some morbidly obese patients, surgery is the only effective type of therapy. Despite bariatric surgery having good outcomes in terms of weight loss, it is associated with some adverse effects: several studies have reported subsequent alterations in bone metabolism. Of the surgical techniques available (laparoscopic gastric banding, Roux-en-Y bypass, biliopancreatic diversion), laparoscopic sleeve gastrectomy (LSG) is currently the technique of choice. Because restrictive procedures such as LSG do not involve bypassing segments of small bowel where micronutrient absorption takes place, fewer metabolic disturbances are expected than with other surgical techniques.
The observed changes in bone metabolism and status in post-bariatric surgery patients potentially involve several mechanisms, including reduced absorption of essential nutrients, diminished calcium absorption leading to secondary hyperparathyroidism, poor vitamin D absorption and restricted energy delivery. In addition, body weight protects against osteoporosis via the bone-strengthening effects of long-term weight bearing. However, long-term decreases in bone mineral density in patients who have undergone successful bariatric surgery are an unexpected, negative effect of this type of therapy.
In the study, parameters of fat and bone tissue and body composition changes are assessed in groups of bariatric patients after LSG, gastric plication and intragastric balloon treatment. Other anticipated benefits of the study treatment include improving the quality of life of. lt will also lead to the introduction of new processes, materials and methods. lt is also possible to expect shortening of the hospital stay, decrease in postoperative morbidity, and the possibility to perform the procedure on an outpatient basis.
The study has been designed as a prospective study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and has been approved by the Ethical Committee of the Faculty of Medicine, University of Ostrava.
The patients enrolled in the study are followed for the period of twelve months. Timetable of the study procedures and controls:
Preoperative examination:
- Demographic data on age, sex, weight, height, smoking
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life Examination 3 months postoperatively
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life Examination 6 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life Examination 12 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life
Statistical data processing for statistical evaluation descriptive statistics are used (arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test, analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence intervals, and logistic regression. Statistical tests are evaluated at the significance level of 5%. Statistical analysis is performed in the "Stata 10" programme. Program EpiData is used for data collection.
- Conditions
- Grade III Obesity, Type 2 Diabetes Mellitus
- Being tested
- Laparoscopic sleeve gastrectomy, Laparoscopic gastric plication, Intragastric balloon, Intragastric balloon implantation
- Keywords
- Obesity, Bariatric medicine, Sleeve gastric resection, Gastric plication, Intragastric ballon, Body composition, Adipokines, Ghrelin, Bone mineral density, Quality of life
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic sleeve gastrectomyProcedure or surgery
Sleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat.
Laparoscopic gastric plicationProcedure or surgery
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.
Intragastric balloonProcedure or surgery
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 implantationDevice
Intragastric balloons (End-Ball, Medsil) will be implanted in the patients with morbid obesity.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Active comparator | Patients undergoing bariatric surgery procedure of laparoscopic sleeve gastrectomy. Receives: Procedure: Laparoscopic sleeve gastrectomy |
| Laparoscopic gastric plication | Active comparator | Patients undergoing bariatric surgery procedure of laparoscopic gastric plication. Receives: Procedure: Laparoscopic gastric plication |
| Intragastric balloon | Active comparator | Patients undergoing bariatric surgery procedure with intragastric balloon implantation. Receives: Procedure: Intragastric balloon; Device: Intragastric balloon implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.).
Measured: 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.).
Measured: 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.
Measured: 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.
Measured: 18 months
Secondary outcomes (2)
Long-term weight reduction assessment in kgs
Evaluation of the success of treatment in terms of long-term weight reduction (difference in body weight in kilograms at the beginning vs. the end of the observation period of 18 months), expressed as TBL (total body weight loss), EWL (excess weight loss), and EBL (excess BMI loss).
Measured: 18 months
Effectiveness evaluation
Evaluation of the effectiveness of the specified bariatric procedures, including new intragastric balloons. The following parameters will be assessed at 3, 6, and 12 months: 1) Per cent total body weight loss and excess weight loss at 12 months, 2) Changes in fasting glycaemia, insulin and hemoglobin A1C at 12 months; 3) Reduction in diabetes medication requirements (for diabetic cohort) at 12 months, and 4) Occurrence rate of serious adverse events judged to be probably or definitely related to the study device.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startMar 2012
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Grade III ObesityStudies of the same condition, open and under way.
- 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ostrava, Vitkovice Hospital, Ostrava, Czech Republic
- Responsible party
- Sponsor
- Investigators
- Marek Bužga, MSc., Ph.D., Principal investigator, Faculty of Medicine, Ostrava University, Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893891
- Sponsor's protocol ID
- LFOU-SGS-Bariatric Surgery
- Other IDs
- SGS10/LF/2012
- Status last verified
- Mar 2018
- First submitted
- 24 Feb 2016
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
PubMed 11234459Suter 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.
PubMed 16839478Bose 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.
PubMed 18820978Buchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg. 2009 Dec;19(12):1605-11. doi: 10.1007/s11695-009-0014-5.
PubMed 19885707Koerner 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.
PubMed 16311215Magni 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.
PubMed 20642443Pobeha 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.
PubMed 21376149Boyce 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.
PubMed 18395508Makovey 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.
PubMed 17371471Hamrick 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.
PubMed 17924050Gomez-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.
PubMed 18563500Greco 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.
PubMed 20518955Wucher 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.
PubMed 18074189Buzga 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.
PubMed 28674838
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Changes of Fat and Bone Tissue After Radical Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02893891
- Acronym / sponsor ID
- LFOU-SGS-Bariatric Surgery
- Conditions
- Grade III Obesity, Type 2 Diabetes Mellitus
- Keywords
- Obesity, Bariatric medicine, Sleeve gastric resection, Gastric plication, Intragastric ballon, Body composition, Adipokines, Ghrelin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Collaborators
- University of Ostrava, Vitkovice Hospital, Ostrava, Czech Republic
- Study start
- Mar 2012 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Sep 2016 (estimated)
- 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.
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.
Detailed description
Obesity is an important medical problem. The number of obese individuals is increasing continuously in response to various environmental and genetic factors. For some morbidly obese patients, surgery is the only effective type of therapy. Despite bariatric surgery having good outcomes in terms of weight loss, it is associated with some adverse effects: several studies have reported subsequent alterations in bone metabolism. Of the surgical techniques available (laparoscopic gastric banding, Roux-en-Y bypass, biliopancreatic diversion), laparoscopic sleeve gastrectomy (LSG) is currently the technique of choice. Because restrictive procedures such as LSG do not involve bypassing segments of small bowel where micronutrient absorption takes place, fewer metabolic disturbances are expected than with other surgical techniques.
The observed changes in bone metabolism and status in post-bariatric surgery patients potentially involve several mechanisms, including reduced absorption of essential nutrients, diminished calcium absorption leading to secondary hyperparathyroidism, poor vitamin D absorption and restricted energy delivery. In addition, body weight protects against osteoporosis via the bone-strengthening effects of long-term weight bearing. However, long-term decreases in bone mineral density in patients who have undergone successful bariatric surgery are an unexpected, negative effect of this type of therapy.
In the study, parameters of fat and bone tissue and body composition changes are assessed in groups of bariatric patients after LSG, gastric plication and intragastric balloon treatment. Other anticipated benefits of the study treatment include improving the quality of life of. lt will also lead to the introduction of new processes, materials and methods. lt is also possible to expect shortening of the hospital stay, decrease in postoperative morbidity, and the possibility to perform the procedure on an outpatient basis.
The study has been designed as a prospective study, which is in conformity with the principles and guidelines of the Helsinki Declaration, good clinical practice and has been approved by the Ethical Committee of the Faculty of Medicine, University of Ostrava.
The patients enrolled in the study are followed for the period of twelve months. Timetable of the study procedures and controls:
Preoperative examination:
- Demographic data on age, sex, weight, height, smoking
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life Examination 3 months postoperatively
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life Examination 6 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life Examination 12 months after surgery
- Assessment of body composition and sampling of blood
- Questionnaires for quality of Life
Statistical data processing for statistical evaluation descriptive statistics are used (arithmetical average, standard deflection, frequency tables), X2 test, Fisher's exact test, analysis of variance (ANOVA), calculating of the OR (odds ratio) with 95 % confidence intervals, and logistic regression. Statistical tests are evaluated at the significance level of 5%. Statistical analysis is performed in the "Stata 10" programme. Program EpiData is used for data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic sleeve gastrectomy | Active comparator | Procedure: Laparoscopic sleeve gastrectomyPatients undergoing bariatric surgery procedure of laparoscopic sleeve gastrectomy. |
| Laparoscopic gastric plication | Active comparator | Procedure: Laparoscopic gastric plicationPatients undergoing bariatric surgery procedure of laparoscopic gastric plication. |
| Intragastric balloon | Active comparator | Procedure: Intragastric balloon, Device: Intragastric balloon implantationPatients undergoing bariatric surgery procedure with intragastric balloon implantation. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- History of conservative obesity treatments selected according to criteria IFSO (BMI greater than 40 or greater than 35 with comorbidities)
Key exclusion criteria (3 listed)
- Thyroid disease
- Diseases of the digestive system associated with disorders of intestinal absorption
- History of corticosteroid therapy in the past 12 months
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 |
|---|---|---|
| Laparoscopic sleeve gastrectomySleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat. | Procedure or surgery | Laparoscopic sleeve gastrectomy |
| Laparoscopic gastric plicationLaparoscopic 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. | Procedure or surgery | Laparoscopic gastric plication |
| Intragastric balloonThe 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. | Procedure or surgery | Intragastric balloon |
| Intragastric balloon implantationIntragastric balloons (End-Ball, Medsil) will be implanted in the patients with morbid obesity. | Device | Intragastric balloon |
Primary outcome
Changes in serum levels of adipose tissue hormones
Time frame: 18 months
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.
Changes in serum levels of lipids
Time frame: 18 months
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.).
Changes in serum levels of osteomarkers
Time frame: 18 months
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.).
IWQOL Questionnaire evaluation
Time frame: 18 months
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.
SF-36 Questionnaire evaluation
Time frame: 18 months
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.
2 secondary outcomes
Long-term weight reduction assessment in kgs
Time frame: 18 months
Effectiveness evaluation
Time frame: 18 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 26 Mar 2018.
- Background: PubMed 11234459Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.
- Background: PubMed 16839478Suter 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.
- Background: PubMed 18820978Bose 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.
- Background: PubMed 19885707Buchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg. 2009 Dec;19(12):1605-11. doi: 10.1007/s11695-009-0014-5.
- Background: PubMed 16311215Koerner 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.
- Background: PubMed 20642443Magni 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.
- Background: PubMed 21376149Pobeha 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.
- Background: PubMed 18395508Boyce 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.
- Background: PubMed 17371471Makovey 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.
- Background: PubMed 17924050Hamrick 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.
- Background: PubMed 18563500Gomez-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.
- Background: PubMed 20518955Greco 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.
- Individual participant dataSharing planned: Undecided
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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.
Marek Bužga, MSc., Ph.D. principal investigator
Faculty of Medicine, Ostrava University, Ostrava
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic sleeve gastrectomy, Laparoscopic gastric plication and Intragastric balloon in people with Grade III Obesity and Type 2 Diabetes Mellitus, run by University Hospital Ostrava at 2 sites in Czechia.
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 1 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 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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 serum levels of adipose tissue hormones (time frame: 18 months). 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 NCT02893891, which also lists 14 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 26 Mar 2018.