Metabolic Changes After Bariatric Surgery

March 22, 2018 updated by: University Hospital Ostrava

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 703 00
        • Vítkovice Hospital Ostrava
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Laparoscopic sleeve gastrectomy
Patients undergoing bariatric surgery procedure of laparoscopic sleeve gastrectomy.
Procedure: Laparoscopic sleeve gastrectomy
Sleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat.
Active Comparator: Laparoscopic gastric plication
Patients undergoing bariatric surgery procedure of laparoscopic gastric plication.
Procedure: 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.
Active Comparator: Intragastric balloon
Patients undergoing bariatric surgery procedure with intragastric balloon implantation.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months
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.).
18 months
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.).
18 months
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.
18 months
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.
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term weight reduction assessment in kgs
Time Frame: 18 months
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
Effectiveness evaluation
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Collaborators

University of Ostrava
Vitkovice Hospital, Ostrava, Czech Republic

Investigators

  • Principal Investigator: Marek Bužga, MSc., Ph.D., Faculty of Medicine, Ostrava University, Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

September 2, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

March 26, 2018

Last Update Submitted That Met QC Criteria

March 22, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LFOU-SGS-Bariatric Surgery
  • SGS10/LF/2012 (Other Grant/Funding Number: Medical Faculty, Ostrava University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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