CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 150 enrolled
Drug / intervention
Laparoscopic sleeve gastrectomy +3 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02893891
NCT02893891N/ACompleted

Metabolic Changes of Fat and Bone Tissue After Radical Bariatric Surgery

University Hospital Ostrava·interventional·Posted Sep 9, 2016·Updated Mar 26, 2018

In Brief

A clinical study evaluating Laparoscopic sleeve gastrectomy, Laparoscopic gastric plication, and 2 other interventions for Grade III Obesity and Type 2 Diabetes Mellitus. Completed, enrolled 150 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCzechia

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2016
Enrollment StartMar 1, 2012
Primary CompletionOct 1, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 9.8 years ago

Interventions

Laparoscopic sleeve gastrectomyprocedure

Sleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat.

Laparoscopic gastric plicationprocedure

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

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.