ObesityBASTANCT02331420
Effect of BAriatric Surgery Versus Optimal Medical Therapy on Cardiovascular Health and Atherosclerosis in Obese, Type II Diabetic Patients
A study testing Gastric bypass and Medical therapy in people with Obesity and Diabetes Mellitus, Type 2, run by Catholic University of the Sacred Heart.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, Atherosclerosis
- What is being tested?
- Gastric bypass and Medical therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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).
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Atherosclerosis
- Being tested
- Gastric bypass, Medical therapy
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
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.
Medical therapyBehavioural
- 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).
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Experimental | Gastric bypass Receives: Procedure: Gastric bypass |
| Optimal Medical Therapy | Active comparator | planned visits, optimized hypoglycemic treatment, diet and lifestyle modification Receives: Behavioral: Medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness)
ecographic assessment of carotid artery intima-media thickness
Measured: 12 months
Endothelial Function (ecographic assessment of flow-mediated dilation and nitrate mediated dilation)
ecographic assessment of flow-mediated dilation and nitrate mediated dilation
Measured: 12 months
Cardiac autonomic function (heart rate variability measurements on 24-hour Holter ECG recordings)
heart rate variability measurements on 24-hour Holter ECG recordings
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geltrude Mingrone, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331420
- Sponsor's protocol ID
- 4569/14
- Acronym
- BASTA
- Status last verified
- Jan 2015
- First submitted
- 2 Jan 2015
- Last updated
- 6 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02331420
- Acronym / sponsor ID
- BASTA / 4569/14
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | Experimental | Procedure: Gastric bypassGastric bypass |
| Optimal Medical Therapy | Active comparator | Behavioral: Medical therapyplanned visits, optimized hypoglycemic treatment, diet and lifestyle modification |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric bypassA 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. | Procedure or surgery | Bariatric Surgery |
| Medical therapy* 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). | Behavioural | Optimal Medical Therapy |
Primary outcome
Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness)
Time frame: 12 months
ecographic assessment of carotid artery intima-media thickness
Endothelial Function (ecographic assessment of flow-mediated dilation and nitrate mediated dilation)
Time frame: 12 months
ecographic assessment of flow-mediated dilation and nitrate mediated dilation
Cardiac autonomic function (heart rate variability measurements on 24-hour Holter ECG recordings)
Time frame: 12 months
heart rate variability measurements on 24-hour Holter ECG recordings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric bypass and Medical therapy in people with Obesity and Diabetes Mellitus, Type 2, run by Catholic University of the Sacred Heart.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subclinical Atherosclerosis (ecographic assessment of carotid artery intima-media thickness) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.