Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus (BY-PLUS)

The aim of this study is to investigate the continued usage of standard diabetes medications in the post operative period following bariatric surgery to determine whether this approach may improve long term diabetes control. At present, the standard of treatment in patients with type 2 diabetes is that all medication is stopped in the immediate postoperative period and only re-started if symptoms of diabetes re-emerge. Although a large proportion of patients with diabetes will initially go in to remission, 80% experience relapse within five years. This study is needed to determine whether continuing medications is not only safe but will improve long term outcomes for patients with diabetes.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Type 2 Diabetes
• Intervention / Treatment: Procedure: Bariatric surgery; Procedure: Bariatric surgery + goal directed medical therapy

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Miras, MRCP; Phone Number: : +44 (0)20 8383 3242; Email: a.miras@nhs.net

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • University College Dublin
    • Contact: Carel le Roux, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• eligible for bariatric surgery according to NICE guidelines (GC 189)
• Type 2 diabetes mellitus
• BMI >30kg/m2

Exclusion Criteria:

• Recent hospitalisation in the past 30 days
• Recurrent hypoglycaemic episodes
• Recurrent hypotensive episodes
• Contraindications to bariatric surgery
• Previous bariatric surgery
• Current pregnancy
• Breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy. Long term diabetes care will be under the supervision of their primary care provider/general practitioner	Procedure: Bariatric surgery; Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner
Experimental: Intervention; Patients will undergo bariatric surgery- either roux en y gastric bypass or sleeve gastrectomy and will have ongoing goal directed medical treatment for their T2DM, titrated to specific end points for BP, HbA1c and lipids.	Procedure: Bariatric surgery + goal directed medical therapy; Patients will undergo bariatric surgery (RYGB or SG) with goal directed medical therapy titrated to specific end points for BP, HbA1c and lipids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients in each group reaching the composite end point	BP<130/80, HbA1c<6.5%, LDL<2.6mmol/L	5 years
Proportion of patients reaching end point for glycemic control	HbA1c<6.5%	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body weight	Change in body weight from baseline (kg)	5 years
Change in BMI	Change in BMI from baseline (kg/m2)	5 years
Change in waist circumference	Change in waist circumference (cm)	5 years
Change in lipid control	Proportion of patients achieving good lipid control (LDL<2.6mmol/L)	5 years
Change in glycaemic control	Change in long term glycaemic control(HbA1c)	5 years
Change in blood pressure	Proportion of patients achieving BP<130/80mmHg	5 years
Change in liver function	Proportion of patients achieving normal liver function tests (ALT, GGT, ALP, AST)	5 years
Change in renal function	Proportion of patients with normal renal function (plasma Cr, eGFR)	5 years
Change in inflammatory markers	Reduction in CRP	5 years
Change in urine albumin: creatinine ratio	Proportion of patients in each group with a uACR<30	5 years
Change in quality of life	Quality of life change as determined by SF-36 and MPH-H	5 years

Collaborators and Investigators

• Sponsor: Imperial College London

Publications and helpful links

General Publications

• Sudlow A, Miras AD, Cohen RV, Kahal H, Townley J, Heneghan H, Le Roux C, Pournaras DJ. Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study. BMJ Open. 2022 Jul 25;12(7):e054313. doi: 10.1136/bmjopen-2021-054313.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): April 1, 2027
• Study Completion (Anticipated): August 1, 2027

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: obesity; type 2 diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20HH5928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The authors shall make data available to the scientific community with as few restrictions as feasible, ensuring anonymisation, while retaining exclusive use until the publication of major outputs.
• IPD Sharing Time Frame: 6 months
• IPD Sharing Access Criteria: Free access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No