- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01046994
Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion (DIA-BPD 25-30)
January 11, 2010 updated by: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
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 Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicola Scopinaro, MD
- Phone Number: +39 010 3537301
- Email: nicola.scopinaro@unige.it
Study Locations
-
-
-
Genova, Italy, 16132
- Recruiting
- Ospedale San Martino
-
Contact:
- Nicola Scopinaro, MD
- Phone Number: +39 010 3537301
- Email: nicola.scopinaro@unige.it
-
Principal Investigator:
- Nicola Scopinaro, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: surgery
biliopancreatic diversion
|
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
|
Active Comparator: standard medical care
patients treated according to the rules of good clinical practice
|
patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diabetes control as defined by FSG and HbA1c
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diabetes control as defined by FSG and HbA1c
Time Frame: 5 years
|
5 years
|
Assessment of prevalence and severity of diabetes complications
Time Frame: 5 years
|
5 years
|
Assessment of patient BMI
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
January 11, 2010
First Submitted That Met QC Criteria
January 11, 2010
First Posted (Estimate)
January 12, 2010
Study Record Updates
Last Update Posted (Estimate)
January 12, 2010
Last Update Submitted That Met QC Criteria
January 11, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIA-BPD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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