Clinical trial NCT02893891: Metabolic Changes After Bariatric Surgery
Official title: Metabolic Changes of Fat and Bone Tissue After Radical Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Grade III Obesity
Type 2 Diabetes Mellitus
Keywords: Obesity
Bariatric medicine
Sleeve gastric resection
Gastric plication
Intragastric ballon
Body composition
Adipokines
Ghrelin
Bone mineral density
Quality of life
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University of Ostrava
name: Vitkovice Hospital, Ostrava, Czech Republic
First posted: 2016-09-09
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in serum levels of adipose tissue hormones
timeFrame: 18 months
measure: Changes in serum levels of lipids
timeFrame: 18 months
measure: Changes in serum levels of osteomarkers
timeFrame: 18 months
measure: IWQOL Questionnaire evaluation
timeFrame: 18 months
measure: SF-36 Questionnaire evaluation
timeFrame: 18 months
Secondary outcomes:
measure: Long-term weight reduction assessment in kgs
timeFrame: 18 months
measure: Effectiveness evaluation
timeFrame: 18 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: Vítkovice Hospital Ostrava
state: Moravian-Silesian Region
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: Faculty of Medicine, Ostrava University, Ostrava
name: Marek Bužga, MSc., Ph.D.
role: PRINCIPAL_INVESTIGATOR
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