Metabolic Changes After Bariatric Surgery

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Metabolic Changes of Fat and Bone Tissue After Radical Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02893891
• Other study ID #: LFOU-SGS-Bariatric Surgery
• Secondary ID: SGS10/LF/2012
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: March 22, 2018
• Start date: March 2012
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Thyroid disease

• Diseases of the digestive system associated with disorders of intestinal absorption

• History of corticosteroid therapy in the past 12 months

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Grade III Obesity
• Type 2 Diabetes Mellitus

Intervention

Procedure:
• Laparoscopic sleeve gastrectomy
Sleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat.
• Laparoscopic gastric plication
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 balloon
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.

Device:
• Intragastric balloon implantation
Intragastric balloons (End-Ball, Medsil) will be implanted in the patients with morbid obesity.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava	Moravian-Silesian Region
Czechia	Vítkovice Hospital Ostrava	Ostrava	Moravian-Silesian Region

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Ostrava	University of Ostrava, Vitkovice Hospital, Ostrava, Czech Republic

Country where clinical trial is conducted

Czechia, 

References & Publications (13)

Bose M, Oliván B, Teixeira J, Pi-Sunyer FX, Laferrère 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):217-29. doi: 10.1007/s11695-008-9696-3. Epub 2008 Sep 27. Review. — View Citation

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. Review. — View Citation

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

Gómez-Ambrosi J, Rodríguez A, Catalán V, Frühbeck 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. Review. — View Citation

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. — View Citation

Hamrick MW, Ferrari SL. Leptin and the sympathetic connection of fat to bone. Osteoporos Int. 2008 Jul;19(7):905-12. Epub 2007 Oct 9. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Epub 2007 Dec 11. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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).	18 months
Secondary	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.	18 months