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Completed

NCT Number: NCT04442698

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kular Hospital

Khanna, Punjab, 141412, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mini-Gastric Bypass -Original Technique post operative patients

Exclusion criteria

-

Treatment and study plan

Mini-Gastric Bypass Original Technique

Procedure

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

Other names: One Anastomosis Bypass

Primary outcomes

  1. Hemoglobin A1c Levels (HbA1c)

    Time frame: 10 years

    HbA1c Levels

  2. Delta Hemoglobin A1c Levels (HbA1c)

    Time frame: 10 years

    Delta HbA1c from Before to After MGB-OT surgery

Sponsors and collaborators

Lead sponsor

Kular Hospital

Other

Registry information

Official study title

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

Acronym: BPLLvHbA1c

Important dates

Study start
2008
Primary completion
2019
Study completion
2020
First posted
Jun 22, 2020
Registry last updated
Jun 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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