Diabetes MellitusDIA-CHIR-MULTNCT01041768
Multicentric Prospective Randomized Trial on Surgery Versus Standard Medical Care in Type 2 Diabetic Patients BMI 30-35
A study testing Bariatric surgery in people with Diabetes Mellitus, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
Trial summary
200 type 2 diabetic patients -BMI between 30-35- will be submitted to bariatric surgery (biliopancreatic diversion BPD or gastric bypass GBP ) and 100 will receive standard medical treatment. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2009to Dec 2015
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥30 and ≤34.9 kg/m2
- age between 35 and 70 years
- duration of diabetes ≥ 5 years
- poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
- presence of significant co-morbidities or complications (such as dyslipidemia, arterial hypertension, impaired renal function, neuropathy, retinopathy, CVD)
Who cannot join
- specific contraindication to obesity surgery or GBP or BPD, including any gastric alteration specifically contraindicating GBP
- HbA1c < 8%
- positive autoantibodies anti-pancreas islet
- serum C-peptide < 0.5 ng/ml
- pregnancy
- medical conditions requiring acute hospitalisation
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Universitaria "San Martino"
Genova, 15067
Nicola Scopinaro, MD, +39 010 3537301, nicola.scopinaro@unige.it
Nicola Scopinaro, MD
About this study
Official title: Multicentric Prospective Randomized Controlled Trial on the Effect of Gastric Bypass and Bilopancreatic Diversion on Type 2 Diabetes Mellitus in Patients With BMI Between 30 and 35
200 type 2 diabetic patients -BMI between 30-35- will be submitted to bariatric surgery (biliopancreatic diversion BPD or gastric bypass GBP ) and 100 will receive standard medical treatment.
Subjects will be monitored during a 5 year period to assess the effects of the surgical procedures on diabetes resolution and control at 1, 3 and 5 years.
Read the detailed description
The study is a multicentric prospective 2-arm randomized controlled trial. Only Centers with at least 50 bariatric surgeries performed during the time window January 2007 and September 2008 will be allowed to participate in the study.
Each Collaborating Center participating in the study will perform only one type of surgical procedure (GBP or BPD), depending on which one it is more familiar with.
Patients will be randomly assigned with a 2 to 1 ratio to receive either bariatric surgery (BS) (either GBP or BPD) or standard antidiabetic care (AC). The randomization will be centralized in the Coordinating Center. Patients assigned to BS will undergo GBP or BPD, depending on each Collaborating Center. Recruitment will continue, independently of the number of recruited patients per center, until the target of 200 GBP+BPD patients, and 100 AC patients will be attained.
After one year since enrollment, patients in AC group will be offered the choice to undergo one of the two surgical procedures, and then will follow the same protocol study as the other surgical patients. In addition, each Collaborating Center will be responsible for selecting one diabetic subject for each operated patient, matched as closely as possible with the patients assigned to surgical therapy, from the local population in medical treatment. These patients will serve as controls for long term mortality and morbidity.
- Conditions
- Diabetes Mellitus
- Being tested
- Bariatric surgery
- Keywords
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Also called biliopancreatic diversion, gastric bypass
Biliopancreatic diversion consists of a distal gastrectomy with a long Roux-en-Y reconstruction, where the enteroenterostomy is placed 50 cm proximal to the ileocecal valve; Gastric bypass consists of creating a small proximal gastric pouch by division of the upper stomach, with reconstruction of the GI continuity by means of a Roux-en-Y loop
| Study group | Role | What they receive |
|---|---|---|
| antidiabetic medical therapy | Active comparator | Not described Receives: Procedure: Bariatric surgery |
| Bariatric Surgery | Experimental | Not described Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving diabetes complete remission (HbA1c 6% or below) or diabetes control (HbA1c between 7% and 6.1%) on free diet and with no antidiabetic medical therapy.
Measured: year 1, 3, 5
Secondary outcomes (1)
Stable reduction of preoperative HbA1c; BMI; mortality/morbidity; Major components of the metabolic syndrome; Diabetes complications; Improvement of beta-cell function; insulin resistance reduction ; Overall and CV disease mortality.
Measured: at and post surgery, 1,3, 5 years since randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale di Desenzano del Garda, Azienda Ospedaliero, Universitaria Pisana, Azienda Ospedaliera Santa Maria Degli Angeli, IRCCS Multimedica, Istituto Clinico Humanitas, Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo, Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti, Ente Ospedaliero Ospedali Galliera, Ospedale S. Giovanni Bosco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University of Rome Tor Vergata, Azienda Ospedaliera San Giovanni Battista, Ospedale S. Timoteo, Termoli, Ospedale Marino, Cagliari, Hospital San Pietro Fatebenefratelli, Azienda Ospedaliera Universitaria Policlinico, Azienda ospedaliera Garibaldi Catania
- Investigators
- Nicola Scopinaro, MD, Principal investigator, Azienda Ospedaliera Universitaria "San Martino", Genova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041768
- Sponsor's protocol ID
- DIA-CHIR-MULT-BMI 30-35
- Acronym
- DIA-CHIR-MULT
- Status last verified
- Dec 2009
- First submitted
- 31 Dec 2009
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Randomized Controlled Trial on the Effect of Gastric Bypass and Bilopancreatic Diversion on Type 2 Diabetes Mellitus in Patients With BMI Between 30 and 35
- ClinicalTrials.gov ID
- NCT01041768
- Acronym / sponsor ID
- DIA-CHIR-MULT / DIA-CHIR-MULT-BMI 30-35
- Conditions
- Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Collaborators
- Ospedale di Desenzano del Garda, Azienda Ospedaliero, Universitaria Pisana, Azienda Ospedaliera Santa Maria Degli Angeli, IRCCS Multimedica, Istituto Clinico Humanitas, Ospedale Polispecialistico Humanitas Gavazzeni, Bergamo, Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti, Ente Ospedaliero Ospedali Galliera, Ospedale S. Giovanni Bosco, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, University of Rome Tor Vergata, Azienda Ospedaliera San Giovanni Battista, Ospedale S. Timoteo, Termoli, Ospedale Marino, Cagliari, Hospital San Pietro Fatebenefratelli, Azienda Ospedaliera Universitaria Policlinico, Azienda ospedaliera Garibaldi Catania
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 1 Jan 2010 (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.
200 type 2 diabetic patients -BMI between 30-35- will be submitted to bariatric surgery (biliopancreatic diversion BPD or gastric bypass GBP ) and 100 will receive standard medical treatment.
Subjects will be monitored during a 5 year period to assess the effects of the surgical procedures on diabetes resolution and control at 1, 3 and 5 years.
Detailed description
The study is a multicentric prospective 2-arm randomized controlled trial. Only Centers with at least 50 bariatric surgeries performed during the time window January 2007 and September 2008 will be allowed to participate in the study.
Each Collaborating Center participating in the study will perform only one type of surgical procedure (GBP or BPD), depending on which one it is more familiar with.
Patients will be randomly assigned with a 2 to 1 ratio to receive either bariatric surgery (BS) (either GBP or BPD) or standard antidiabetic care (AC). The randomization will be centralized in the Coordinating Center. Patients assigned to BS will undergo GBP or BPD, depending on each Collaborating Center. Recruitment will continue, independently of the number of recruited patients per center, until the target of 200 GBP+BPD patients, and 100 AC patients will be attained.
After one year since enrollment, patients in AC group will be offered the choice to undergo one of the two surgical procedures, and then will follow the same protocol study as the other surgical patients. In addition, each Collaborating Center will be responsible for selecting one diabetic subject for each operated patient, matched as closely as possible with the patients assigned to surgical therapy, from the local population in medical treatment. These patients will serve as controls for long term mortality and morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antidiabetic medical therapy | Active comparator | Procedure: Bariatric surgery |
| Bariatric Surgery | Experimental | Procedure: Bariatric surgery |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI ≥30 and ≤34.9 kg/m2
- age between 35 and 70 years
- duration of diabetes ≥ 5 years
- poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
- presence of significant co-morbidities or complications (such as dyslipidemia, arterial hypertension, impaired renal function, neuropathy, retinopathy, CVD)
Key exclusion criteria (12 listed)
- specific contraindication to obesity surgery or GBP or BPD, including any gastric alteration specifically contraindicating GBP
- HbA1c < 8%
- positive autoantibodies anti-pancreas islet
- serum C-peptide < 0.5 ng/ml
- 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 |
|---|---|---|
| Bariatric surgeryAlso: biliopancreatic diversion, gastric bypassBiliopancreatic diversion consists of a distal gastrectomy with a long Roux-en-Y reconstruction, where the enteroenterostomy is placed 50 cm proximal to the ileocecal valve; Gastric bypass consists of creating a small proximal gastric pouch by division of the upper stomach, with reconstruction of the GI continuity by means of a Roux-en-Y loop | Procedure or surgery | Bariatric Surgery, antidiabetic medical therapy |
Primary outcome
Proportion of patients achieving diabetes complete remission (HbA1c 6% or below) or diabetes control (HbA1c between 7% and 6.1%) on free diet and with no antidiabetic medical therapy.
Time frame: year 1, 3, 5
1 secondary outcome
Stable reduction of preoperative HbA1c; BMI; mortality/morbidity; Major components of the metabolic syndrome; Diabetes complications; Improvement of beta-cell function; insulin resistance reduction ; Overall and CV disease mortality.
Time frame: at and post surgery, 1,3, 5 years since randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
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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.
Nicola Scopinaro, MD principal investigator
Azienda Ospedaliera Universitaria "San Martino", Genova, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery in people with Diabetes Mellitus, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
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 5 inclusion and 12 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 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Nicola Scopinaro, MD (+39 010 3537301, nicola.scopinaro@unige.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving diabetes complete remission (HbA1c 6% or below) or diabetes control (HbA1c between 7% and 6.1%) on free diet and with no antidiabetic medical therapy. (time frame: year 1, 3, 5). 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 30 Mar 2010.