Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

Conditions
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Obesity, Type 2 Diabetes

Intervention / Treatment
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* Procedure: Bariatric surgery + goal directed medical therapy
* Procedure: Bariatric surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>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<br>* Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner<br>|
| Experimental: Intervention<br>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<br>* Patients will undergo bariatric surgery (RYGB or SG) with goal directed medical therapy titrated to specific end points for BP, HbA1c and lipids<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, type 2 diabetes