NCT03891056

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

March 6, 2019

Last Update Submit

March 25, 2019

Conditions

Diabetes MellitusMetabolic SurgerySleeve GastrectomyBPGY

Keywords

Diabetes MellitusMetabolic SurgeryBMI 30-35BPGYVertical Gastrectomy

Outcome Measures

Primary Outcomes (1)

  • Number of participans with normal glycosylated hemoglobin levels

    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 Outcomes (4)

  • 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

Study Arms (2)

Gastric bypass

ACTIVE COMPARATOR

Twenty patients will be randomly assigned to perform a laparoscopic gastric bypass.

Procedure: metabolic surgery

Slevee gastrectomy

ACTIVE COMPARATOR

Twenty patients will be randomly assigned to perform a sleeve gastrectomy

Procedure: metabolic surgery

Interventions

metabolic surgeryPROCEDURE

The study will randomize patients into two arms, one where a laparoscopic gastric bypass will be performed and another that will perform slevee gastrectomy.

Gastric bypassSlevee gastrectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous bariatric surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General and Digestive Surgery of the Dr. Peset Hospital

Valencia, 46017, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Central Study Contacts

Nuria Peris Tomás, PhD

CONTACT

0034 617019132nuriapt27@gmail.com

Jose Angel Diez Ares, PhD

CONTACT

0034 619702452jose_angel_diez_ares@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 26, 2019

Study Start

January 15, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2022

Last Updated

March 26, 2019

Record last verified: 2019-03

Locations

ES(1)