Metabolic Changes After Bariatric Surgery
Condition: Grade III Obesity; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Laparoscopic sleeve gastrectomy; Laparoscopic gastric plication; Intragastric balloon; Intragastric balloon implantation
Intervention type(s): Procedure; Procedure; Procedure; Device
Intervention description(s): Sleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat.; 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.; 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 balloons (End-Ball, Medsil) will be implanted in the patients with morbid obesity.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Bariatric medicine; Sleeve gastric resection; Gastric plication; Intragastric ballon; Body composition; Adipokines; Ghrelin; Bone mineral density; Quality of life