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Study of laparoscopic biliopancreatic diversion modality for treatment of type 2 diabetes in patients with a BMI between 30 and 35. [Estudio y resultados de una modalidad de derivación biliopancreática laparoscópica para el tratamiento de la diabetes tipo 2 en pacientes con IMC entre 30 y 35]

Study and results of a laparoscopic biliopancreatic diversion modality for diabetes type 2 treatment in patients with a BMI between 30 and 35: a randomized prospective clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN59207763
Enrollment
74
Registered
2012-02-20
Start date
2012-02-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

A five trocars laparoscopic surgical intervention, a gastric cross-section leaving a 300 ml gastric reservoir, a biliopancreatic derivation with a jejunoileal anastomosis at 120 cm from the ileocecal

Sponsors

Aragon Institute of Health Sciences [Instituto Aragonés de Ciencias de la Salud] (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with type 2 diabetes 2. Between 18 and 60 years old 3. Body mass index (BMI) between 30 and 35 4. Less than 10 years of illness evolution 5. Subject to medical treatment (oral antidiabetics, and/or insulin) and without enough control 6. More than 2 years of medical treatment and adequate pancreatic reserve (haemoglobin glycosylated determination with a result of more than 7)

Exclusion criteria

Exclusion criteria: 1. Positive anti glutamic acid decarboxylase (GAD) antibodies 2. Patients diagnosed with type 2 diabetes controlled with one or two oral antidiabetics, preanesthetic evaluation between 4 or 5 Anesthetic Society of America criteria values (ASA) 3. Laparoscopic and surgery general contraindications

Design outcomes

Primary

MeasureTime frame
1. Normal glucose levels 2. Insulin blood level 3. Normal nutritional state assessed against calcium, iron, protein and vitamin metabolism 4. BMI between 20 and 30 5. Quality of life

Secondary

MeasureTime frame
1. Insulin production related hormones evolution (GIP, GLP1, ghrelin, neuropeptide YY) 2. Glucose metabolism (glucagon test, basal proinsulin)

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026