Metabolic Surgery; Gastric Bypass vs Sleeve Gastrectomy; Efects Over Type 2 DM With Bad Metabolic Control (MSO1CT) (MSO1CT)

March 25, 2019 updated by: Nuria Peris Tomás, Hospital Universitario Doctor Peset

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46017
        • Recruiting
        • Department of General and Digestive Surgery of the Dr. Peset Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gastric bypass
Twenty patients will be randomly assigned to perform a laparoscopic gastric bypass.
Procedure: 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.
Active Comparator: Slevee gastrectomy
Twenty patients will be randomly assigned to perform a sleeve gastrectomy
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with partial remission or improvement of diabetes
Time Frame: 1 year after surgery

Partial remission: Subdiabetic hyperglycemia (Hb1Ac 6%-6,4%, FBG 100-125mg/dl) in the absence anti diabetic medication.

Improvement: statistically significant reduction in Hb1Ac and FBG not meeting criteria for remission or decrease in anti diabetic medication requirement (by one oral agent, or 1/2 reduction in dose)
1 year after surgery
Comparison of weight loss between the two techniques; bypass and sleeve.
Time Frame: 2 years after surgery
To measure weight loss and its maintenance during the follow-up in both techniques. For this, the patients will be weighed in the postoperative period at month, 3, 6 12 months and then annually.
2 years after surgery
Evaluation of postoperative complications in patients undergoing bypass and slevee with Clavien-Dindo classification.
Time Frame: 1 month after surgery

Grade I: any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.

Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutritional also included.

Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU management. Grade V: Death of a patient.
1 month after surgery
Comparison postoperative pain in sleeve and bypass with analogue assessment scale of postoperative pain.
Time Frame: 3 days postoperative
The postoperative pain of the patients during the first three postoperative days will be evaluated with the visual analogue scale from 0 (no pain) to 10 (unbearable pain).
3 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Doctor Peset

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

March 6, 2019

First Submitted That Met QC Criteria

March 25, 2019

First Posted (Actual)

March 26, 2019

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSO1CT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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