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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2016-12-31

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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus Bariatric Surgery Biliopancreatic Diversion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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surgery

biliopancreatic diversion

Group Type EXPERIMENTAL

biliopancreatic diversion

Intervention Type PROCEDURE

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

standard medical care

patients treated according to the rules of good clinical practice

Group Type ACTIVE_COMPARATOR

antidiabetics

Intervention Type DRUG

patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice

Interventions

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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

Intervention Type PROCEDURE

antidiabetics

patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice

Intervention Type DRUG

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

Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No