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

Diabetes Clinical Trial

— BPLLvHbA1c  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04442698
• Other study ID #: KularH
• Status: Completed
• Start date: January 1, 2008
• Est. completion date: January 1, 2020

Study information

• Verified date: June 2020
• Source: Kular Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Mini-Gastric Bypass -Original Technique post operative patients

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Diabetes
• Surgery

Intervention

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

Locations

Country	Name	City	State
India	Kular Hospital	Khanna	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Kular Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c Levels (HbA1c)	HbA1c Levels	10 years
Primary	Delta Hemoglobin A1c Levels (HbA1c)	Delta HbA1c from Before to After MGB-OT surgery	10 years