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Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Atherosclerosis in Obese, Type II Diabetic Patients (BASTA)

Primary Purpose

Obesity, Diabetes Mellitus, Type 2, Atherosclerosis

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Gastric bypass

Medical therapy

About this trial

This is an interventional diagnostic trial for Obesity

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

type 2 diabetes: the American Diabetes Association (ADA) recommends the following criteria for diagnosis of diabetes: HbA1c ≥6.5% OR fasting plasma glucose‡ ≥126 mg/dL (7.0 mmol/L) OR 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; 75-g glucose load should be used OR random plasma glucose concentration ≥200 mg/dL (11.1 mmol/L) in persons with symptoms of hyperglycemia or hyperglycemic crisis;
indication to bariatric surgery: BMI ≥35 kg/m2 and one or more obesity related co-morbidities, including Type 2 Diabetes Mellitus.

Exclusion Criteria:

overt cardiovascular disease (as assessed by clinical evaluation, physical examination, 12-lead ECG, 2D-echocardiogram);
smoking habit;
associated medical conditions, as chronic kidney disease (defined as creatinine clearance <60 mL/min/L.73m2), liver cirrhosis, malignancies, chronic congestive heart failure, acute or chronic inflammatory disease;
specific contraindication to bariatric surgery;
pregnancy;
medical conditions requiring acute hospitalization;
psychological conditions which may hamper patient's cooperation;
geographic inaccessibility.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bariatric Surgery

Optimal Medical Therapy

Arm Description

Gastric bypass

planned visits, optimized hypoglycemic treatment, diet and lifestyle modification

Outcomes

Primary Outcome Measures

Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness)

ecographic assessment of carotid artery intima-media thickness

Endothelial Function (ecographic assessment of flow-mediated dilation and nitrate mediated dilation)

ecographic assessment of flow-mediated dilation and nitrate mediated dilation

Cardiac autonomic function (heart rate variability measurements on 24-hour Holter ECG recordings)

heart rate variability measurements on 24-hour Holter ECG recordings

Secondary Outcome Measures

Full Information

NCT ID

NCT02331420

First Posted

January 2, 2015

Last Updated

January 5, 2015

Sponsor

Catholic University of the Sacred Heart

1. Study Identification

Unique Protocol Identification Number

NCT02331420

Brief Title

Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Atherosclerosis in Obese, Type II Diabetic Patients

Acronym

BASTA

Official Title

Prospective Randomized Controlled Trial on the Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Progression of Atherosclerosis in Obese, Type II Diabetic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Catholic University of the Sacred Heart

4. Oversight

5. Study Description

Brief Summary

To assess the impact of weight loss due to bariatric surgery, as compared to the effect of optimal medical therapy alone on endothelial function, subclinical atherosclerosis, cardiovascular autonomic function in obese patient affected by type 2 diabetes.The study consists in a 2-arm randomized trial, in which patients will be randomly assigned to bariatric surgery or optimal medical therapy. Each patient will be studied at baseline (T0) and 12 months thereafter (T1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Diabetes Mellitus, Type 2, Atherosclerosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bariatric Surgery

Arm Type

Experimental

Arm Description

Gastric bypass

Arm Title

Optimal Medical Therapy

Arm Type

Active Comparator

Arm Description

planned visits, optimized hypoglycemic treatment, diet and lifestyle modification

Intervention Type

Procedure

Intervention Name(s)

Gastric bypass

Intervention Description

A subcardial gastric pouch with a 30±10 ml capacity will be created 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 gastro-enterostomy.

Intervention Type

Behavioral

Intervention Name(s)

Medical therapy

Intervention Description

Assessment and treatment by a multidisciplinary team (diabetologist, dietitian, nurse); Planned visits at baseline and at 1, 3, 6, 9, 12, and 24 months after study entry; Oral hypoglycemic agents and insulin doses optimized on an individual basis with the aim of reaching a glycated hemoglobin level of less than 7%; Programs for diet and lifestyle modification, including reduced overall energy and fat intake (<30% total fat, <10% saturated fat, and high fiber content) and increased physical exercise (≥30 minutes of brisk walking every day, possibly associated with moderate-intensity aerobic activity twice a week); low-calorie diet (every day: 50% carbohydrate, 30% protein and 20% lipids).

Primary Outcome Measure Information:

Title

Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness)

Description

ecographic assessment of carotid artery intima-media thickness

Time Frame

12 months

Title

Endothelial Function (ecographic assessment of flow-mediated dilation and nitrate mediated dilation)

Description

ecographic assessment of flow-mediated dilation and nitrate mediated dilation

Time Frame

12 months

Title

Cardiac autonomic function (heart rate variability measurements on 24-hour Holter ECG recordings)

Description

heart rate variability measurements on 24-hour Holter ECG recordings

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: type 2 diabetes: the American Diabetes Association (ADA) recommends the following criteria for diagnosis of diabetes: HbA1c ≥6.5% OR fasting plasma glucose‡ ≥126 mg/dL (7.0 mmol/L) OR 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test; 75-g glucose load should be used OR random plasma glucose concentration ≥200 mg/dL (11.1 mmol/L) in persons with symptoms of hyperglycemia or hyperglycemic crisis; indication to bariatric surgery: BMI ≥35 kg/m2 and one or more obesity related co-morbidities, including Type 2 Diabetes Mellitus. Exclusion Criteria: overt cardiovascular disease (as assessed by clinical evaluation, physical examination, 12-lead ECG, 2D-echocardiogram); smoking habit; associated medical conditions, as chronic kidney disease (defined as creatinine clearance <60 mL/min/L.73m2), liver cirrhosis, malignancies, chronic congestive heart failure, acute or chronic inflammatory disease; specific contraindication to bariatric surgery; pregnancy; medical conditions requiring acute hospitalization; psychological conditions which may hamper patient's cooperation; geographic inaccessibility.

12. IPD Sharing Statement

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Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Atherosclerosis in Obese, Type II Diabetic Patients

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