Type 2 Diabetes MellitusNCT00996294
Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)
A study testing biliopancreatic diversion, gastric bypass 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
Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control. 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, gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2007to Oct 2013
- 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
- Type 2 diabetes mellitus
- Duration of diabetes ≥ 3 years
- Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP)
Who cannot join
- Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass
- Pregnancy
- Medical conditions requiring acute hospitalisation
- Severe diabetes complications or associated medical conditions [such as blindness, end-stage renal failure (i.e. serum creatinine >2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)]
- Recent (within preceding 12 months) myocardial infarction, stroke or TIA
- Unstable angina pectoris
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- Psychological conditions which may hamper patient's cooperation
- Geographic inaccessibility
- Any condition which, in the judgment of the Investigator, may make risky the participation in the study or bias the results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Treatment of Type 2 Diabetes Mellitus in Patients With BMI <35 kg/m2 (Italian Title: "La Terapia Chirurgica Del Diabete Mellito di Tipo 2 Nel Paziente Con BMI Inferiore a 35 kg/m2")
Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.
- Being tested
- biliopancreatic diversion, gastric bypass
- 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 diversion, gastric bypassProcedure 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 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 |
|---|---|---|
| surgery | Experimental | patients will be submitted to biliopancreatic diversion or gastric bypass Receives: Procedure: biliopancreatic diversion, gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes control, define by FSG and HbA1c
Measured: 1 year
Secondary outcomes (1)
Diabetes control defined by FSG and HbA1c
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 posted16 Oct 2009 (estimated)
- Study startNov 2007
- Primary completionOct 2009
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
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
- Investigators
- Nicola Scopinaro, MD, Principal investigator, Azienda Ospedaliera Universitaria "San Martino", Genova, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996294
- Sponsor's protocol ID
- DIA-CHIR
- Status last verified
- Oct 2009
- First submitted
- 15 Oct 2009
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, Andraghetti G, Catalano M, Cordera R. Effects of gastric bypass on type 2 diabetes in patients with BMI 30 to 35. Obes Surg. 2014 Jul;24(7):1036-43. doi: 10.1007/s11695-014-1206-1.
PubMed 24647849Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, D'Alessandro G, Parodi C, Weiss A, Andraghetti G, Catalano M, Cordera R. The effects of biliopancreatic diversion on type 2 diabetes mellitus in patients with mild obesity (BMI 30-35 kg/m2) and simple overweight (BMI 25-30 kg/m2): a prospective controlled study. Obes Surg. 2011 Jul;21(7):880-8. doi: 10.1007/s11695-011-0407-0.
PubMed 21541815Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Fried M, Briatore L, D'Alessandro G, Andraghetti G, Cordera R. Effects of biliopanceratic diversion on type 2 diabetes in patients with BMI 25 to 35. Ann Surg. 2011 Apr;253(4):699-703. doi: 10.1097/SLA.0b013e318203ae44.
PubMed 21475009
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
- Surgical Treatment of Type 2 Diabetes Mellitus in Patients With BMI <35 kg/m2 (Italian Title: "La Terapia Chirurgica Del Diabete Mellito di Tipo 2 Nel Paziente Con BMI Inferiore a 35 kg/m2")
- ClinicalTrials.gov ID
- NCT00996294
- Acronym / sponsor ID
- DIA-CHIR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2013 (estimated)
- First posted
- 16 Oct 2009 (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.
Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | Experimental | Procedure: biliopancreatic diversion, gastric bypasspatients will be submitted to biliopancreatic diversion or gastric bypass |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- Duration of diabetes ≥ 3 years
- Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP)
Key exclusion criteria (9 listed)
- Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass
- Pregnancy
- Medical conditions requiring acute hospitalisation
- Severe diabetes complications or associated medical conditions [such as blindness, end-stage renal failure (i.e. serum creatinine >2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)]
- Recent (within preceding 12 months) myocardial infarction, stroke or TIA
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 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 | surgery |
Primary outcome
Diabetes control, define by FSG and HbA1c
Time frame: 1 year
1 secondary outcome
Diabetes control defined by FSG and HbA1c
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.
- Derived from this study: PubMed 24647849Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, Andraghetti G, Catalano M, Cordera R. Effects of gastric bypass on type 2 diabetes in patients with BMI 30 to 35. Obes Surg. 2014 Jul;24(7):1036-43. doi: 10.1007/s11695-014-1206-1.
- Derived from this study: PubMed 21541815Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, D'Alessandro G, Parodi C, Weiss A, Andraghetti G, Catalano M, Cordera R. The effects of biliopancreatic diversion on type 2 diabetes mellitus in patients with mild obesity (BMI 30-35 kg/m2) and simple overweight (BMI 25-30 kg/m2): a prospective controlled study. Obes Surg. 2011 Jul;21(7):880-8. doi: 10.1007/s11695-011-0407-0.
- Derived from this study: PubMed 21475009Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Fried M, Briatore L, D'Alessandro G, Andraghetti G, Cordera R. Effects of biliopanceratic diversion on type 2 diabetes in patients with BMI 25 to 35. Ann Surg. 2011 Apr;253(4):699-703. doi: 10.1097/SLA.0b013e318203ae44.
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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 biliopancreatic diversion, gastric bypass 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 3 inclusion and 9 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.
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?
Diabetes control, define 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?
On the ClinicalTrials.gov record for NCT00996294, which also lists 3 linked publications.
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.