Clinical trial NCT02963662: Impact of Gut Hormones and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery
Official title: Impact of Gut Hormone and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Chronic Inflammation
Type 2 Diabetes
Keywords: obesity
bariatric surgery
gut hormones
inflammatory adipokine
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Obesity and type 2 diabetes, dyslipidemia and related metabolic disease has become a threat to our national life and health which is showing a trend. Bariatric Surgery had been confirmed definite therapeutic effect to obesity and type 2 diabetes. However, laparoscopic gastric bypass and laparoscopic sleeve gastrectomy have the similar outcome to type 2 diabetes, but the two surgical methods and principles are completely different, which mechanisms are not yet clear. Lots of literature report adipose tissue releases adipokines and inflammatory cytokines induced chronic inflammation and obesity-related complications (insulin resistance and Type 2 diabetes).It is not clear whether to change these gastrointestinal hormones, adipokines and secretion of inflammatory cytokines with the operation, which play a therapeutic effect of obesity-related complications and diabetes. In addition, the investigators are wonder whether gut hormones, adipokines and inflammatory cytokines have some correlation in different severity obese patients,. It is worth to explore that could intestinal hormones, adipokines and inflammatory factors levels guide us to choice the different surgical approach to different severity obese patients. The investigators tried to investigate different surgical methods to alleviate diabetes and other metabolic diseases mechanisms though hormones and inflammatory factors and adipose tissue inflammation level and compare the impact of intestinal hormones and inflammatory adipokines of the two surgical approaches.


Eligibility criteria: Inclusion Criteria:

* According to the standard of obesity Obesity Task Force established in 2001, BMI≥28k / m2 with obesity-related metabolic diseases in patients, or BMI≥35kg / m2 in patients with severe obesity were selected.
* The age of 14-65 years.
* Self-capacity, non-drug dependence, psychological illness.
* Not prompted stomach ulcers, erosions, tumors, polyps, atrophic gastritis and other stomach diseases in the preoperative endoscopy.
* No history of stomach and abdominal surgery.
* Case Source: First Affiliated Hospital of Jinan University, by the same team of doctors performed the surgical procedure.

Exclusion Criteria:

* Whom did not follow the inclusion criteria

Primary outcomes:
measure: The levels of Ghrelin, Peptide YY,Glucagon,Gastric Inhibitory Peptide ,and GLP2 in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
timeFrame: within 4 hours
measure: The levels of Insulin in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
timeFrame: within 4 hours
measure: The levels of Leptin in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
timeFrame: within 4 hours
measure: The levels of GLP1 in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
timeFrame: within 4 hours
measure: The levels of adipokines and inflammatory cytokines in the fasting state at preoperation in patients with BMI ≥35 kg/m2 or BMI ≥28 kg/m2 and T2D or metabolic syndrome.
timeFrame: within 4 hours
Secondary outcomes:
measure: The gut hormone levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
timeFrame: 12 months
measure: The Insulin levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
timeFrame: 12 months
measure: The Leptin levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
timeFrame: 12 months
measure: The GLP1 levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
timeFrame: 12 months
measure: The adipokines and inflammatory cytokines levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Jinan University
name: Jingge Yang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang J, Gao Z, Williams DB, Wang C, Lee S, Zhou X, Qiu P. Effect of laparoscopic Roux-en-Y gastric bypass versus laparoscopic sleeve gastrectomy on fasting gastrointestinal and pancreatic peptide hormones: A prospective nonrandomized trial. Surg Obes Relat Dis. 2018 Oct;14(10):1521-1529. doi: 10.1016/j.soard.2018.06.003. Epub 2018 Jun 14.