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Diet and Medical Therapy Versus Bariatric Surgery in Type 2 Diabetes (DIBASY)

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ClinicalTrials.gov Identifier: NCT00888836
Recruitment Status : Completed
First Posted : April 28, 2009
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):
Geltrude Mingrone, Catholic University of the Sacred Heart

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Procedure: Gastric bypass Procedure: Bilio-pancreatic diversion Behavioral: anti-diabetic drugs and behavioral suggestions Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
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
Study Start Date : April 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with type 2 diabetes and BMI ≥35 kg.m-2
  • age between 30 and 60 years
  • duration of diabetes ≥ 5 years
  • poor glycemic control (i.e., HbA1c ≥ 7.0%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)

Exclusion Criteria:

  • pregnancy
  • medical conditions requiring acute hospitalisation
  • severe diabetes complications or associated medical conditions (such as blindness, end-stage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure)
  • recent (within preceding 12 months) myocardial infarction, stroke or TIA
  • unstable angina pectoris
  • psychological conditions which may hamper patient's cooperation
  • geographic inaccessibility
  • any condition which, in the judgement of the Investigator, may make risky the participation in the study or bias the results
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888836


Locations
Italy
Catholic University, Faculty of Medicine
Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Geltrude Mingrone, MD, PhD Catholic University Hospital
Study Chair: Giuseppe Nanni, MD Catholic University Hospital
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Geltrude Mingrone, Assistant Professor of Internal Medicine, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT00888836     History of Changes
Other Study ID Numbers: UCSC-2009-1
First Posted: April 28, 2009    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: July 2014

Keywords provided by Geltrude Mingrone, Catholic University of the Sacred Heart:
bariatric surgery
GBP
BPD
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs