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

Primary Purpose

Obesity, Type 2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Bariatric surgery + goal directed medical therapy
Bariatric surgery
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, type 2 diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University College DublinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Proportion of patients in each group reaching the composite end point
BP<130/80, HbA1c<6.5%, LDL<2.6mmol/L
Proportion of patients reaching end point for glycemic control
HbA1c<6.5%

Secondary Outcome Measures

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

Full Information

First Posted
June 12, 2020
Last Updated
August 4, 2022
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT04432025
Brief Title
Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus
Acronym
BY-PLUS
Official Title
Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2027 (Anticipated)
Study Completion Date
August 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
obesity, type 2 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomly allocated to the control arm (bariatric surgery- either RYGB or SG) or intervention (bariatric surgery- either RYGB or SG + goal directed medical therapy for t2DM)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery + goal directed medical therapy
Intervention Description
Patients will undergo bariatric surgery (RYGB or SG) with goal directed medical therapy titrated to specific end points for BP, HbA1c and lipids
Intervention Type
Procedure
Intervention Name(s)
Bariatric surgery
Intervention Description
Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner
Primary Outcome Measure Information:
Title
Proportion of patients in each group reaching the composite end point
Description
BP<130/80, HbA1c<6.5%, LDL<2.6mmol/L
Time Frame
5 years
Title
Proportion of patients reaching end point for glycemic control
Description
HbA1c<6.5%
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in body weight
Description
Change in body weight from baseline (kg)
Time Frame
5 years
Title
Change in BMI
Description
Change in BMI from baseline (kg/m2)
Time Frame
5 years
Title
Change in waist circumference
Description
Change in waist circumference (cm)
Time Frame
5 years
Title
Change in lipid control
Description
Proportion of patients achieving good lipid control (LDL<2.6mmol/L)
Time Frame
5 years
Title
Change in glycaemic control
Description
Change in long term glycaemic control(HbA1c)
Time Frame
5 years
Title
Change in blood pressure
Description
Proportion of patients achieving BP<130/80mmHg
Time Frame
5 years
Title
Change in liver function
Description
Proportion of patients achieving normal liver function tests (ALT, GGT, ALP, AST)
Time Frame
5 years
Title
Change in renal function
Description
Proportion of patients with normal renal function (plasma Cr, eGFR)
Time Frame
5 years
Title
Change in inflammatory markers
Description
Reduction in CRP
Time Frame
5 years
Title
Change in urine albumin: creatinine ratio
Description
Proportion of patients in each group with a uACR<30
Time Frame
5 years
Title
Change in quality of life
Description
Quality of life change as determined by SF-36 and MPH-H
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Miras, MRCP
Phone
: +44 (0)20 8383 3242
Email
a.miras@nhs.net
Facility Information:
Facility Name
University College Dublin
City
Dublin
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carel le Roux, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
35879015
Citation
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.
Results Reference
derived

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Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

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