Medication Following Bariatric Surgery for Type 2 Diabetes Mellitus

Not Applicable

Recruiting

• Conditions: Obesity; Type 2 Diabetes
• Interventions: Procedure: Bariatric surgery + goal directed medical therapy; Procedure: Bariatric surgery

• Registration Number: NCT04432025
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Study First Posted: 2020-06-16
• Study Start: 2021-04-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-08
• Primary Completion: 2027-04-01
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Bariatric surgery + goal directed medical therapy	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.
Control	Bariatric surgery	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University College Dublin; 🇮🇪 Dublin, Ireland