Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion

Conditions
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Type 2 Diabetes Mellitus, Bariatric Surgery, Biliopancreatic Diversion

Intervention / Treatment
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* Procedure: biliopancreatic diversion
* Drug: antidiabetics


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery<br>biliopancreatic diversion | Procedure: biliopancreatic diversion<br>* 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<br>|
| Active Comparator: standard medical care<br>patients treated according to the rules of good clinical practice | Drug: antidiabetics<br>* patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes control as defined by FSG and HbA1c |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes control as defined by FSG and HbA1c |  | 5 years | 
| Assessment of prevalence and severity of diabetes complications |  | 5 years | 
| Assessment of patient BMI |  | 5 years |