Impact of Gut Hormones and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery

Obesity Clinical Trial

Official title:

Impact of Gut Hormone and Inflammatory Adipokines in Obese Patients Underwent Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963662
• Other study ID #: 2014A020212219
• Status: Completed
• Phase: N/A
• First received: August 17, 2016
• Last updated: November 10, 2016
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: First Affiliated Hospital of Jinan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Inflammation
• Inflammation
• Obesity
• Type 2 Diabetes

Intervention

Procedure:
• laparoscopic Roux-en-Y gastric bypass
Laparoscopic Roux-en-Y gastric bypass was one of the interventions pre-specified to be administered to participants. The patients undergo Roux-en-Y gastric bypass (RYGB group) following a comprehensive evaluation for the surgical indication
• laparoscopic sleeve gastrectomy
Laparoscopic sleeve gastrectomy was the other intervention pre-specified to be administered to participants. The patients undergo sleeve gastrectomy (SG group) following a comprehensive evaluation for the surgical indication

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gao Zhiguang

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Units of gut hormones include Ghrelin in pg/m,Peptide YY in pg/ml,Glucagon in pg/ml,Gastric Inhibitory Peptide in pg/ml, GLP2 in pg/ml. Enzyme-Linked Immunosorbent Assay to measure the levels of these gut hormones	within 4 hours	Yes
Primary	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.	The unit of Insulin is ulu/L.Enzyme-Linked Immunosorbent Assay to measure the levels of Insulin	within 4 hours	Yes
Primary	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.	The unit of Leptin is ng/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of Leptin	within 4 hours	Yes
Primary	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.	The unit of GLP1 is pmol/L.Enzyme-Linked Immunosorbent Assay to measure the levels of GLP1	within 4 hours	Yes
Primary	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.	Units of adipokines and inflammatory cytokines include Adiponectin in pg/ml, Interleukin 1ßin pg/ml , Interleukin 6 in pg/ml, Interleukin 18 in pg/ml, Lipopolysaccharide in pg/ml, NLRP3 in pg/ml, TLR4 in pg/ml, TNF-a in pg/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines	within 4 hours	Yes
Secondary	The gut hormone levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery	"surgery"means laparoscopic gastric bypass or laparoscopic sleeve gastrectomy. Units of gut hormones include Ghrelin in pg/m,Peptide YY in pg/ml,Glucagon in pg/ml,Gastric Inhibitory Peptide in pg/ml, GLP2 in pg/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of these gut hormones	12 months	Yes
Secondary	The Insulin levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery	The unit of Insulin is ulu/L.Enzyme-Linked Immunosorbent Assay to measure the levels of Insulin.	12 months	Yes
Secondary	The Leptin levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery	The unit of Leptin is ng/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of Leptin	12 months	Yes
Secondary	The GLP1 levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery	The unit of GLP1 is pmol/L.Enzyme-Linked Immunosorbent Assay to measure the levels of GLP1	12 months	Yes
Secondary	The adipokines and inflammatory cytokines levels in the fasting state at 1 month, 3 months, 6 months and 12 months after surgery	Effect of laparoscopic gastric bypass or laparoscopic sleeve gastrectomy on preoperative and postoperative adipokines and inflammatory cytokines.Units of them include Adiponectin in pg/ml, Interleukin 1ßin pg/ml , Interleukin 6 in pg/ml, Interleukin 18 in pg/ml, Lipopolysaccharide in pg/ml, NLRP3 in pg/ml, TLR4 in pg/ml, TNF-a in pg/ml.Enzyme-Linked Immunosorbent Assay to measure the levels of adipokines and inflammatory cytokines.	12 months	Yes