Tailored Bilio-Pancreatic Limb and HbA1c 10 Years Post Mini-Gastric Bypass (BPLLvHbA1c)

June 19, 2020 updated by: Dr. Robert Rutledge, Kular Hospital

Tailored Bilio-Pancreatic Limb Length and Hemoglobin A1c Levels 10 Years Following Mini-Gastric Bypass Original Technique

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is general agreement that Diabetes is now or soon will be a worldwide epidemic. Studies also make clear the devastating impact of diabetes on both healthcare costs in addition to the costs in human lives, suffering and disability. It is also clear that treatment that lowers Hemoglobin A1c (HbA1c) will result in improved outcomes proportional to the decrease, saving both lives and costs. Unfortunately medical and lifestyle therapy routinely result in less than ideal resolution of elevated HbA1c levels. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy is 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.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

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

Study Locations

  • India
    • Punjab
      • Khanna, Punjab, India, 141412
        • Kular Hospital

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Mini-Gastric Bypass -Original Technique post operative patients

Exclusion Criteria:

-

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic MGB post op patients
Procedure: Mini-Gastric Bypass Original Technique
Follow up of the Surgical procedure outcomes in diabetics. Procedure Mini-Gastric Bypass Original Technique
Other Names:
  • One Anastomosis Bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c Levels (HbA1c)
Time Frame: 10 years
HbA1c Levels
10 years
Delta Hemoglobin A1c Levels (HbA1c)
Time Frame: 10 years
Delta HbA1c from Before to After MGB-OT surgery
10 years

Collaborators and Investigators

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

Sponsor

Kular Hospital

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 1, 2008

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

June 19, 2020

First Submitted That Met QC Criteria

June 19, 2020

First Posted (Actual)

June 22, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • KularH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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