Physiological Impact of Each Component of the Biliopancreatic Diversion With Duodenal Switch and Sleeve Gastrectomy

Gastrectomy Clinical Trial

Official title:

Physiological Impact of Each Component of the Biliopancreatic Diversion With Duodenal Switch and Sleeve Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02069223
• Other study ID #: 21003
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2014
• Last updated: May 15, 2014
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2014
• Source: Laval University
• Contact: Marc Lapointe
• Phone: 4186568711
• Email: marc.lapointe[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Bariatric surgery procedures promote weight loss by limiting the amount of food consumed through reduction of the size of the stomach and by decreasing absorption of nutrients through reorganizing or bypassing portions of the small intestine. Among the procedures used to induce weight loss, sleeve gastrectomy (SG) was initially developed in the early 90's as the restrictive component of a biliopancreatic diversion with duodenal switch (BPD-DS). It was then offered by laparoscopy as a staged-approach in order to reduce peri-operative complications in high-risk patients. The second step of the surgery (i.e. the duodenal switch) was planned when sufficient weight loss had been obtained. However, it was observed that some patients experienced appreciable weight loss with the SG alone, and did not require a second-stage surgery, thus avoiding the side-effects of a malabsorptive surgery. This led to the surge in popularity of SG as a stand-alone operation, because of its relative technical simplicity, feasibility, and good outcomes. Multiple mechanisms have been postulated to induce metabolic recovery and weight loss following surgery. The independent effects of each component of the BPD-DS with SG have never been investigated in humans within a well-controlled study design. The general objective of the present project is to assess the impact of each component of the BPD-DS and SG, either combined of separated, on physiological variables potentially responsible for metabolic recovery. Patients will be randomized to undergo one of three surgical sequences: 1) SG followed by BPD-DS one year later; 2) BPD-DS followed by SG one year later; or 3) SG and BPD-DS within a single operation. A series of tests will be performed at baseline, at 1 year, and 2 years after the initial surgery. We propose two Specific Aims to asses 1) the impact of each surgical component on the hormonal determinants of metabolic recovery; and 2) the impact of weight loss responses on subcutaneous and visceral adipose tissue function improvements. This project will help better understand the mechanisms underlying metabolic recovery following weight loss surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Men and Women between 18-60 years old;

• BMI = 45 à = 55 kg/m2;

• Subjects capable of understanding and being able to sign a consent form;

• Subjects capable of following the protocol directives, including the proposed visits (timeline);

• Subjects living within a reasonable distance from the hospital and capable of being present at all required visits.

Exclusion Criteria:

• Pregnant women or women who plan on becoming pregnant during the study, or women in fertile age range who refuse proper contraceptive methods during the study. (Must have negative pregnancy test at the moment of enrollment and use medically acceptable contraception which include: oral contraceptives, injectable or implantable contraceptives, intrauterine devices or double-barrier method ie. condoms and diaphragm);

• Diabetics

• Subjects with HbA1c = 6,5 % or fasting Glucose =7mmol/l or non-fasting Glucose =11mmol/l;

• Previous oesophagal, gastric or bariatric surgery;

• Irritable bowel syndrome, unexplained intermittent vomiting, severe abdominal pain, diarrhea or chronic constipation;

• History of duodenal or gastric ulcers;

• Pre-operative hypoalbuminuria (<35g/l);

• History of renal disease, hepatic disease (cirrhosis) or severe cardiac or pulmonary disease;

• Corticosteroid intake in the previous month;

• Presence of psychiatric problems or behavioral issues that could limit subject's capacity at understanding the procedure and to conform to medical/surgical recommendations;

• History of drug use or alcoholism in previous 12 months before study;

• History of inflammatory diseases of the gastro-intestinal tract (Esophagitis, varices, gastric or duodenal ulcers, Crohn's disease, congenital or acquired anomalies of the digestive tract).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliopancreatic Diversion With Duodenal Switch
• Gastrectomy

Intervention

Procedure:
• Gastrectomy

• BPD-DS

Locations

Country	Name	City	State
Canada	CRIUCPQ	Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Laval University	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec, Johnson & Johnson

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the changes in Satiety Levels and the changes in Incretin Levels	Satiety determination via questionnaires; Incretin levels	Baseline, 12, 24 months	No
Primary	Measure the changes of adipose tissue cells sizes and macrophage infiltration	Adipose Tissue cell sizing; Adipose Tissue macrophage infiltration via histology	Baseline, 12 months	No