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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891056
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Nuria Peris Tomás, Hospital Universitario Doctor Peset

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Metabolic Surgery Sleeve Gastrectomy BPGY Procedure: metabolic surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
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.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)


  2. 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.

  3. 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.


  4. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03891056


Contacts
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Contact: Nuria Peris Tomás, PhD 0034 617019132 nuriapt27@gmail.com
Contact: Jose Angel Diez Ares, PhD 0034 619702452 jose_angel_diez_ares@hotmail.com

Locations
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Spain
Department of General and Digestive Surgery of the Dr. Peset Hospital Recruiting
Valencia, Spain, 46017
Contact: Nuria Peris Tomás, PhD    0034 617019132    nuriapt27@gmail.com   
Contact: Jose Angel Diez Ares, PhD    0034 619702452    jose_angel_diez_ares@hotmail.com   
Sponsors and Collaborators
Hospital Universitario Doctor Peset
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Responsible Party: Nuria Peris Tomás, Principal Investigator, Hospital Universitario Doctor Peset
ClinicalTrials.gov Identifier: NCT03891056    
Other Study ID Numbers: MSO1CT
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nuria Peris Tomás, Hospital Universitario Doctor Peset:
Diabetes Mellitus
Metabolic Surgery
BMI 30-35
BPGY
Vertical Gastrectomy
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases