Diet and Medical Therapy Versus Bariatric Surgery in Type 2 Diabetes (DIBASY)
It is generally held that ß-cell function is irreversibly lost already at the time the disease manifests itself and thereafter continues to decline linearly with time. Several studies, however, have documented the possibility that ß-cell function may be restored, at least partially, in type 2 diabetes. Of major relevance to the issue of ß-cell recovery in diabetes are the following findings:
- bariatric surgery in morbidly obese patients with type 2 diabetes can restore euglycaemia, the acute insulin response to glucose and insulin sensitivity;
- recent studies have reported that diabetic subjects return to euglycaemia and normal insulin levels within days after surgery, long before a significant weight loss has occurred; and
- whereas gastric bypass (GBP) improves insulin sensitivity in proportion to weight loss, bilio-pancreatic diversion (BPD) improves insulin action out of proportion to weight loss, i.e., it normalizes it at a time when patients are still markedly obese. Because RYGB is a predominantly restrictive procedure involving the foregut, whereas BPD is a predominantly malabsorptive procedure involving the distal gastro-intestinal (GI) tract, these findings suggest that the control of both insulin action and ß-cell function is influenced by signals originating from the GI tract.
The principal aim of this study is to verify the effect on type 2 diabetes mellitus (T2DM) of GBP and BPD, the two operations which have shown specific actions on glucose homeostasis control, in type 2 diabetic patients with BMI > 35 kg/m2, and to compare this effect with matched T2DM control patients receiving the standard of medical care.
|Type 2 Diabetes||Procedure: Gastric bypass Procedure: Bilio-pancreatic diversion Behavioral: anti-diabetic drugs and behavioral suggestions||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Controlled Trial on the Effect of Gastric Bypass and Biliopancreatic Diversion on Type 2 Diabetes Mellitus in Patients With BMI > 35 vs. Medical Therapy|
- To assess the efficacy of bariatric surgery in inducing partial or total remission of type 2 diabetes mellitus, as compared to standard medical anti-diabetic care (STC). [ Time Frame: 5 years ]
- Secondary endpoints include percentage change of fasting plasma glucose levels, glycated hemoglobin, weight, waist circumference, blood pressure, cholesterol, HDL-cholesterol and triglycerides, hard cardiovascular risk and quality of life. [ Time Frame: 5 years ]
We aim at measuring in the long term (5 years after enrollment) by the glycemic holter the degree of glucose control in the patients belonging to the 3 arms of our randomized, controlled study comparing conventional medical therapy with bilio-pancreatic diversion and Roux-en-Y gastric bypass. To this end, the patients will wear the glycemic holter over 24-48 hours and the results recorded. The patients are already recording periodical 7 points glucose self monitoring.
Quality of life will be investigated at 5 years from enrollment by the RAND 36-Item Health Survey. It taps 8 health concepts: physical functioning, bodily pain, role of limitations deriving from physical health problems, limitations due to physical or emotional problems, emotional well being, social functioning, energy/fatigue, and general health perception. It also includes a single item that provides an indication of perceived change in health. The questionnaire will be administered by the physician.
|Study Start Date:||April 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: GBP
Type 2 diabetic subjects with BMI ≥ 35, poor glycemic control (HbA1c ≥ 7.0%) and diabetes duration ≥ 5 years undergo gastric bypass
Procedure: Gastric bypass
Gastric bypass (GBP): A subcardial gastric pouch with a 30±10 ml capacity will be created on a naso-gastric 36F calibrating tube by sectioning the stomach with a linear stapler 3-4 cm horizontally on the lesser curve, 4 cm distal to the e-g junction, and then vertically until attainment of the angle of Hiss. After identification of the Treitz ligament, the jejunum will be transected at 100 cm from the ligament of Treitz and the two stumps will be closed. The distal stump will be anastomosed to the distal end of the gastric pouch. The preferred gastro-jejunal anastomosis is the totally hand-sewn one, but it can be performed using any other the technique the surgeon is more familiar with. Finally, the proximal stump of the transacted bowel will be joined end-to-side to the jejunum 150 cm distal to the gastroenterostomy.
Active Comparator: BPD 2
Type 2 diabetic subjects with BMI ≥ 35, poor glycemic control (HbA1c ≥ 7.0%) and diabetes duration ≥ 5 years undergo bilio-pancreatic diversion
Procedure: Bilio-pancreatic diversion
Biliopancreatic diversion (BPD): A distal two-third gastrectomy will be carried out aiming at leaving an about 400 ml gastric remnant. The gastrointestinal continuity will be re-established by sectioning the small bowel 300 cm proximal to the ileocecal valve, closing the intestinal stumps, and joining the proximal one end-to-side to the distal ileum at 50 cm from the ligament of Treitz. The distal stump of the transacted bowel will be anastomosed to the left corner of the gastric stump, preferably in a totally hand-sewn fashion.
Active Comparator: Med Ter3
Type 2 diabetic subjects with BMI ≥ 35, poor glycemic control (HbA1c ≥ 7.0%) and diabetes duration ≥ 5 yearsundergo medical therapy
Behavioral: anti-diabetic drugs and behavioral suggestions
Medical therapies (oral hypoglycemic agents and insulin) are optimized on an individual basis. Lifestyle modification programs, including reduced energy and fat (<30% total fat and <10% saturated fat, high fibre content) intake and increased physical exercise (suggested at least 30 minutes of brisk walking every day possibly associated with a moderate intensity aerobic activity twice a week), are tailor made by an experienced diabetologist assisted by a dietitian. After the two years, the patients in control group will be offered the choice to undergo one of the two surgical procedures.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00888836
|Catholic University, Faculty of Medicine|
|Rome, Italy, 00168|
|Principal Investigator:||Geltrude Mingrone, MD, PhD||Catholic University Hospital|
|Study Chair:||Giuseppe Nanni, MD||Catholic University Hospital|