Type 2 Diabetes MellitusPhase 3DIA-BPD 25-30NCT01046994
Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion
A Phase 3 study testing biliopancreatic diversion and antidiabetics in people with Type 2 Diabetes Mellitus and Bariatric Surgery, 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
A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Bariatric Surgery, Biliopancreatic Diversion
- What is being tested?
- biliopancreatic diversion and antidiabetics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2009to Dec 2016
- Phase
- Phase 3
- 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
- age: 35-70 years
- diabetes duration: >5 years
- documented poor glycemic control (HbA1c =>8% despite medical treatment according to GCP)
- presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)
- availability to comply with the entire follow-up
Who cannot join
- general contraindications to BPD (applies also to medical controls)
- presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration <0.5 mcg/L
- blindness
- severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
- heart failure
- recent history (less than 12 months) of myocardial infarction, stroke or TIA
Show all 12Show fewer
- unstable angina
- pregnancy
- previous or concomitant malignancy
- severe active inflammatory, neurologic, or cardiovascular conditions
- geographic inaccessibility
- any condition which, in the opinion of the Principal 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
Ospedale San Martino
Genova, 16132
Nicola Scopinaro, MD, +39 010 3537301, nicola.scopinaro@unige.it
Nicola Scopinaro, MD
About this study
A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. A new prospective study was then planned with the aim to gain insight in the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.
- Being tested
- biliopancreatic diversion, antidiabetics
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliopancreatic diversionProcedure or surgery
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
antidiabeticsDrug
patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice
| Study group | Role | What they receive |
|---|---|---|
| surgery | Experimental | biliopancreatic diversion Receives: Procedure: biliopancreatic diversion |
| standard medical care | Active comparator | patients treated according to the rules of good clinical practice Receives: Drug: antidiabetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes control as defined by FSG and HbA1c
Measured: 1 year
Secondary outcomes (3)
Diabetes control as defined by FSG and HbA1c
Measured: 5 years
Assessment of prevalence and severity of diabetes complications
Measured: 5 years
Assessment of patient BMI
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- Santa Chiara Hospital, Istituto Nazionale per lo Studio e la Cura dei Tumori
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046994
- Sponsor's protocol ID
- DIA-BPD
- Acronym
- DIA-BPD 25-30
- Status last verified
- Jan 2010
- First submitted
- 11 Jan 2010
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion
- ClinicalTrials.gov ID
- NCT01046994
- Acronym / sponsor ID
- DIA-BPD 25-30 / DIA-BPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Collaborators
- Santa Chiara Hospital, Istituto Nazionale per lo Studio e la Cura dei Tumori
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 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.
A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. A new prospective study was then planned with the aim to gain insight in the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery | Experimental | Procedure: biliopancreatic diversionbiliopancreatic diversion |
| standard medical care | Active comparator | Drug: antidiabeticspatients treated according to the rules of good clinical practice |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age: 35-70 years
- diabetes duration: >5 years
- documented poor glycemic control (HbA1c =>8% despite medical treatment according to GCP)
- presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)
- availability to comply with the entire follow-up
Key exclusion criteria (12 listed)
- general contraindications to BPD (applies also to medical controls)
- presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration <0.5 mcg/L
- blindness
- severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)
- heart failure
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 |
|---|---|---|
| biliopancreatic diversionbiliopancreatic 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 | Procedure or surgery | surgery |
| antidiabeticspatients are treated with conventional antidiabetic drugs according to the rules of good clinical practice | Drug | standard medical care |
Primary outcome
Diabetes control as defined by FSG and HbA1c
Time frame: 1 year
3 secondary outcomes
Diabetes control as defined by FSG and HbA1c
Time frame: 5 years
Assessment of prevalence and severity of diabetes complications
Time frame: 5 years
Assessment of patient BMI
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing biliopancreatic diversion and antidiabetics in people with Type 2 Diabetes Mellitus and Bariatric Surgery, 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 12 Jan 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Diabetes control as defined by FSG and HbA1c (time frame: 1 year). 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 12 Jan 2010.