METABOLIC SURGERY FOR PATIENTS WITH TYPE 2 DM AND GRADE I OBESITY (BMI 30-35 kg/m2) WITH BAD METABOLIC CONTROL (HbA1c > 7,5%) PROTOCOL
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Number of participans with normal glycosylated hemoglobin levels
Study Overview
Brief Summary
The aim of the study is to compare the efficacy of laparoscopic gastric bypass versus vertical gastrectomy for the resolution of DM in patients with BMI 30-35.
Detailed Description
Hyphotesis Laparoscopic gastric bypass is the elective technique in the face of sleeve gastrectomy to improve or heal type 2 diabetes mellitus in patientes with BMI 30-35 kg/m2.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Both sex patients aged between 18 and 65 years old
- •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
Exclusion Criteria
- •Patients who do not accomplish the previosly described inclusion criteria; Patient's refusal to take part in the study; Patients with symptomatology of gastroesophageal reflux disease or with upper gastrointestinal series compatible with this desease.
- •Previous bariatric surgery
Arms & Interventions
Gastric bypass
Twenty patients will be randomly assigned to perform a laparoscopic gastric bypass.
Intervention: metabolic surgery (Procedure)
Slevee gastrectomy
Twenty patients will be randomly assigned to perform a sleeve gastrectomy
Intervention: metabolic surgery (Procedure)
Outcomes
Primary Outcomes
Number of participans with normal glycosylated hemoglobin levels
Time Frame: 1 year after surgery
Healing will be defined when HbA1c and fasting glycaemia levels are inside normal limits (Hb1Ac \< 6%, FBG\<100mg/dl) without needing oral hypoglycemic agents.
Secondary Outcomes
- Number of participants with partial remission or improvement of diabetes(1 year after surgery)
- Comparison of weight loss between the two techniques; bypass and sleeve.(2 years after surgery)
- Evaluation of postoperative complications in patients undergoing bypass and slevee with Clavien-Dindo classification.(1 month after surgery)
- Comparison postoperative pain in sleeve and bypass with analogue assessment scale of postoperative pain.(3 days postoperative)
Investigators
Nuria Peris Tomás
Principal Investigator
Hospital Universitario Doctor Peset