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NCT Number: NCT04432025

Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Ireland

Location status: Recruiting

Location contact

Carel le Roux, PhD

CONTACT

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Bariatric surgery + goal directed medical therapy

Procedure

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

bariatric surgery

Procedure

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

Primary outcomes

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

    Time frame: 5 years

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

  2. Proportion of patients reaching end point for glycemic control

    Time frame: 1 year

    HbA1c<6.5%

Secondary outcomes

  1. Change in body weight

    Time frame: 5 years

    Change in body weight from baseline (kg)

  2. Change in BMI

    Time frame: 5 years

    Change in BMI from baseline (kg/m2)

  3. Change in waist circumference

    Time frame: 5 years

    Change in waist circumference (cm)

  4. Change in lipid control

    Time frame: 5 years

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

  5. Change in glycaemic control

    Time frame: 5 years

    Change in long term glycaemic control(HbA1c)

  6. Change in blood pressure

    Time frame: 5 years

    Proportion of patients achieving BP<130/80mmHg

  7. Change in liver function

    Time frame: 5 years

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

  8. Change in renal function

    Time frame: 5 years

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

  9. Change in inflammatory markers

    Time frame: 5 years

    Reduction in CRP

  10. Change in urine albumin: creatinine ratio

    Time frame: 5 years

    Proportion of patients in each group with a uACR<30

  11. Change in quality of life

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Miras, MRCP

CONTACT

[email protected]

: +44 (0)20 8383 3242

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: BY-PLUS

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 16, 2020
Registry last updated
Aug 8, 2022

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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