NCT04442698

Brief Summary

Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare costs in addition to the costs in human lives, suffering and disability. Treatment that lowers Hemoglobin A1c (HbA1c) improved outcomes. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy was the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed
Last Updated

June 22, 2020

Status Verified

June 1, 2020

Enrollment Period

11 years

First QC Date

June 19, 2020

Last Update Submit

June 19, 2020

Conditions

DiabetesSurgery

Outcome Measures

Primary Outcomes (2)

  • Hemoglobin A1c Levels (HbA1c)

    HbA1c Levels

    10 years

  • Delta Hemoglobin A1c Levels (HbA1c)

    Delta HbA1c from Before to After MGB-OT surgery

    10 years

Study Arms (1)

Diabetic MGB post op patients

Diabetic MGB post op patients

Procedure: Mini-Gastric Bypass Original Technique

Interventions

Mini-Gastric Bypass Original TechniquePROCEDURE

Follow up of the Surgical procedure outcomes in diabetics. Procedure Mini-Gastric Bypass Original Technique

Also known as: One Anastomosis Bypass
Diabetic MGB post op patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients having undergone Mini-Gastric Bypass -Original Technique post operative patients

You may qualify if:

  • Mini-Gastric Bypass -Original Technique post operative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kular Hospital

Khanna, Punjab, 141412, India

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

June 19, 2020

First Posted

June 22, 2020

Study Start

January 1, 2008

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

June 22, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)