Metabolic Surgery; Gastric Bypass vs Sleeve Gastrectomy; Efects Over Type 2 DM With Bad Metabolic Control (MSO1CT)
NCT ID: NCT03891056
Last Updated: 2019-03-26
Study Results
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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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-01-15
2022-01-31
Brief Summary
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Detailed Description
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MAIN AIM:
To compare cure rate through the improvement in glycated hemoglobin and fasting glycaemia after laparoscopic gastric bypass face to sleeve gastrectomy.
SECONDARY AIMS:
To quantify both insulin and oral hypoglycemic agents dose decrease. To measure weight loss and its maintenance during the follow-up in both techniques.
To compare postoperative complications. To compare postoperative pain. To compare follow-up complications.
Matherial and methods. Type of study: Randomized clinical trial double blind with two paralel groups.
RANDOMIZATION. Randomization will be a simple one with Epidat 4.1. A number sequence will be carried out and it will be kept in opaque closed envelopes. The envelope will be opened the operation day and the surgery technique will be decided randomly, according to the randomization sequence. The study will be blinded for patients, who will not know the surgery technique they will go on. Dieticians and Endocrinologists who will follow the patients up after the surgery neither will not know it, so differences in dietary recommendations will not appear with this masking.
Subjects of study The study will rely on patients with Diabetes Mellitus type 2 and grade I obesity with HbA1c higher than 7,5 % (BMI 30-35 kg/m2 and type 2 diabetes with bad glycemic control) detected in Endocrinology and Nutrition Department of Hospital Doctor Peset. Patients will go on bariatric surgery in General and Digestive Surgery Department of the same hospital. Patients who accomplish established inclusion criteria will be recruited until sample size is completed; a minimum 40 patients size is estimated (with a type I error of 5% and a power of 80%) and the will be randomized in two 20 people branches. Investigation will follow The World Medical Association and Declaration of Helsinki guidelines.
Definition of healing and improvement. Healing will be defined when HbA1c and fasting glycaemia levels are inside normal limits without needing oral hypoglycemic agents.
Improvement will be defined when decreasing medication doses for keeping normal fasting glycaemia and level of HbA1c under 6%.
Period of study:
The required one for fulfilling the sample. An inclusion of 40 patients in two years is expected.
Variable-gathering period The patient will be call for attending the external consultation of the Endocrinology and Nutrition Department of Hospital Doctor Peset. Each subject will carry out an initial study with nutritional status assesment, cardiovascular risk factors and comorbidities (hypertension, obstructive sleep apnea, dyslipidemia), as well as discarding secondary causes of obesity. In basal state, 2 days, 3, 6 and 12 months after the surgery, a blood test consisting of biochemical analysis, specific proteins, serum hormones, inmunological markers, full blood count and hemostasis will be made. The patient will carry out dietary intervention and follow-up in each phase of the process.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gastric bypass
Twenty patients will be randomly assigned to perform a laparoscopic gastric bypass.
metabolic surgery
The study will randomize patients into two arms, one where a laparoscopic gastric bypass will be performed and another that will perform slevee gastrectomy.
Slevee gastrectomy
Twenty patients will be randomly assigned to perform a sleeve gastrectomy
metabolic surgery
The study will randomize patients into two arms, one where a laparoscopic gastric bypass will be performed and another that will perform slevee gastrectomy.
Interventions
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metabolic surgery
The study will randomize patients into two arms, one where a laparoscopic gastric bypass will be performed and another that will perform slevee gastrectomy.
Eligibility Criteria
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Inclusion Criteria
* Class I obesity (BMI 30-35 kg/m2) with bad metabolic control (DM-2 with HbA1c \> 7,5%) and non-insulin anti-diabetic treatment failure (it is necessary \>10 years of known diabetes evolution time, C-peptide≥ 1 ng/ml, no insulin treatment, at least two oral hypoglycemic agents treatment);
* Patients who accomplish the follow-up protocol designed by both Surgery and Endocrinology departments
* Informed consent signed
Previous bariatric surgery
18 Years
65 Years
ALL
No
Sponsors
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Hospital Universitario Doctor Peset
OTHER
Responsible Party
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Nuria Peris Tomás
Principal Investigator
Locations
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Department of General and Digestive Surgery of the Dr. Peset Hospital
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MSO1CT
Identifier Type: -
Identifier Source: org_study_id
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