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ObesityBY-PLUSNCT04432025

Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

A study testing Bariatric surgery + goal directed medical therapy and Bariatric surgery in people with Obesity and Type 2 Diabetes, run by Imperial College London at 1 site in Ireland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Type 2 Diabetes
What is being tested?
Bariatric surgery + goal directed medical therapy and Bariatric surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteIreland
Study dates
1 Apr 2021to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexander Miras, MRCP contact

: +44 (0)20 8383 3242

a.miras@nhs.net

Ireland1 site, 1 recruiting

  • University College Dublin

    Dublin

    Carel le Roux, PhD

    Recruiting

Other trials in Ireland

About this study

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.

Being tested
Bariatric surgery + goal directed medical therapy, Bariatric surgery
Keywords
obesity, type 2 diabetes
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bariatric surgery + goal directed medical therapyProcedure or surgery

    Patients will undergo bariatric surgery (RYGB or SG) with goal directed medical therapy titrated to specific end points for BP, HbA1c and lipids

  • Bariatric surgeryProcedure or surgery

    Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner

Study groups in NCT04432025
Study groupRoleWhat they receive
ControlActive comparatorPatients 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
Receives: Procedure: Bariatric surgery
InterventionExperimentalPatients 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.
Receives: Procedure: Bariatric surgery + goal directed medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients in each group reaching the composite end point

    BP<130/80, HbA1c<6.5%, LDL<2.6mmol/L

    Measured: 5 years

  2. Proportion of patients reaching end point for glycemic control

    HbA1c<6.5%

    Measured: 1 year

Secondary outcomes (11)

  1. Change in body weight

    Change in body weight from baseline (kg)

    Measured: 5 years

  2. Change in BMI

    Change in BMI from baseline (kg/m2)

    Measured: 5 years

  3. Change in waist circumference

    Change in waist circumference (cm)

    Measured: 5 years

  4. Change in lipid control

    Proportion of patients achieving good lipid control (LDL<2.6mmol/L)

    Measured: 5 years

  5. Change in glycaemic control

    Change in long term glycaemic control(HbA1c)

    Measured: 5 years

  6. Change in blood pressure

    Proportion of patients achieving BP<130/80mmHg

    Measured: 5 years

  7. Change in liver function

    Proportion of patients achieving normal liver function tests (ALT, GGT, ALP, AST)

    Measured: 5 years

  8. Change in renal function

    Proportion of patients with normal renal function (plasma Cr, eGFR)

    Measured: 5 years

  9. Change in inflammatory markers

    Reduction in CRP

    Measured: 5 years

  10. Change in urine albumin: creatinine ratio

    Proportion of patients in each group with a uACR<30

    Measured: 5 years

  11. Change in quality of life

    Quality of life change as determined by SF-36 and MPH-H

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start1 Apr 2021
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04432025
Sponsor's protocol ID
20HH5928
Acronym
BY-PLUS
Status last verified
Aug 2022
First submitted
12 Jun 2020
Last updated
8 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 35879015

Questions about this trial

What is this clinical trial studying?

A study testing Bariatric surgery + goal directed medical therapy and Bariatric surgery in people with Obesity and Type 2 Diabetes, run by Imperial College London at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexander Miras, MRCP (: +44 (0)20 8383 3242, a.miras@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients in each group reaching the composite end point (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04432025, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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