Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)

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)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00996294

Enrollment

Registered

2009-10-16

Start date

2007-11-30

Completion date

2013-10-31

Last updated

2010-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Biliopancreatic Diversion, Gastric Bypass, Type 2 Diabetes Mellitus

Brief 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.

Interventions

PROCEDUREbiliopancreatic diversion, gastric bypass

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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

Inclusion criteria

* 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)

Exclusion criteria

* 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 * 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

Design outcomes

Primary

Measure	Time frame
Diabetes control, define by FSG and HbA1c	1 year

Secondary

Measure	Time frame
Diabetes control defined by FSG and HbA1c	5 years

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026