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]

ISRCTN ISRCTN59207763
DOI https://doi.org/10.1186/ISRCTN59207763
Secondary identifying numbers PI10/02340
Submission date
23/01/2012
Registration date
20/02/2012
Last edited
31/07/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Type 2 diabetes is an illness in which the body does not produce or respond correctly to insulin, an important hormone that transforms glucose into the energy that the body needs to work. People with diabetes are prone to suffer other illnesses and this makes its forecast worse. Type 2 diabetes affects over 5% of adults in the world (250 million people). It is estimated that by 2025 this will have doubled. Medical treatment can’t cure diabetes. However, bariatric surgery cures diabetes in morbidly obese patients and this is not related to weight loss, so it would cure diabetes in non morbidly obese patients. It is observed that glucose tolerance improved in diabetic patient after a gastrectomy and the immediacy of that improvement appeared to be due to the involvement of hormones that control insulin secretion. This showed that the diabetes cure was linked to hormone alterations in the small intestine because of the food transit variation, stimulating insulin secretion in the pancreas. The aim of this study is to assess the effects of a surgical treatment consisting of a stomach reduction and a biliopancreatic bypass that redirects the food to avoid the first section of the intestine and go directly to the last part. This act stimulates natural insulin secretion.

Who can participate?
Patients aged between 18 and 60 with type 2 diabetes.

What does the study involve?
Participants will be randomly allocated into one of two groups. One group will receive the surgical treatment described above and the other group will receive the standard drug treatment for diabetes.

What are the possible benefits and risks of participating?
There could be adverse events related to the surgery (chance of death below 2%, serious complications in around 7% and minor complications in around 17%) and also a reduction of the vitamins absorbed in the digestion that could be solved by taking vitamin supplements.

Where is the study run from?
Royo Vilanova Hospital (Spain).

When is study starting and how long is it expected to run for?
The study started in February 2012 and will finish 14 months later.

Who is funding the study?
Aragon Institute of Health Sciences (Spain).

Who is the main contact?
José Antonio Fatás Cabeza

Contact information

Dr José Antonio Fatás Cabeza
Scientific

Servicio de Cirugía General y del Aparato Digestivo
Hospital Royo Vilanova
Avenida San Gregorio 30
Zaragoza
50015
Spain

Study information

Study designProspective randomized controlled clinical trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleStudy 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
Study objectivesThe minimally invasive surgical technique proposed by the research team prevents the passage of food into the duodenum and causes an early filling of the ileum, triggering an enzymatic cascade that stimulates an autologous secretion of insulin in patients with pancreatic reserve.

This surgical technique results in the cure of type 2 diabetes (defined by the Diabetes American Association as a fasting glucose less than 100 mg/dl in venous plasma, a glycemia at 2 hours after an oral glucose overload with 75 g less than 140 mg/dl and HbA1c less than 6.5% and normal insulin levels in blood) without causing malnutritional states and maintaining the BMI between normal values and overweight and improving quality of life.
Ethics approval(s)The Clinical Research Ethics Committee of Aragon [Comité Ético de Investigación Clínica de Aragón (CEICA)], 16/03/2011, ref: C.I.EC10/028
Health condition(s) or problem(s) studiedType 2 diabetes
InterventionA 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 valve and a jejunal section at 320 cm from the ileocecal valve.

The pharmacological treatment for the control group will be the usual one used in clinical practice for the control of type 2 diabetic patients. This treatment includes antidiabetics and/or insulin.

The drug type, dose and administration frequency depends on the patient and its characteristics.
The more common antidiabetic treatments include the following ones: gliclazide, glimepiride, repaglinide, metformin, pioglitazone, rosiglitazone, sitagliptine, vildagliptine and exenatide.
Intervention typeOther
Primary outcome measure1. 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 outcome measures1. Insulin production related hormones evolution (GIP, GLP1, ghrelin, neuropeptide YY)
2. Glucose metabolism (glucagon test, basal proinsulin)
Overall study start date01/02/2012
Completion date01/04/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants74
Key inclusion criteria1. 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)
Key exclusion criteria1. 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
Date of first enrolment01/02/2012
Date of final enrolment01/04/2013

Locations

Countries of recruitment

  • Spain

Study participating centre

Servicio de Cirugía General y del Aparato Digestivo
Zaragoza
50015
Spain

Sponsor information

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

Avenida Gómez Laguna 25
Planta 3
Zaragoza
50009
Spain

Website http://www.ics.aragon.es/
ROR logo "ROR" https://ror.org/05p0enq35

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan