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Management of Type 2 Diabetes After Gastric Bypass Surgery

NCT01213563 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-08-21

No results posted yet for this study

Summary

Gastric bypass surgery has been proposed as an effective treatment strategy for type 2 diabetes mellitus (T2DM), but thus far algorithms for the management of T2DM immediately after surgery have not been established. The investigators designed an algorithm to achieve good glycaemic control in patients with insulin-requiring T2DM upon discharge after gastric bypass surgery, and evaluated this algorithm for feasibility, efficacy, and safety.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Actrapid insulin+Gloucose

On admission to hospital all pre-operative oral antidiabetic agents and insulin are stopped and glucose monitoring is carried out every four hours at the same time as routine observations. Actrapid insulin+ Glucose is administered as per standard sliding scale (Appendix A). Just prior to discharge, total insulin administered over the previous 24 hour post-operative period is calculated. Based on the results of ward based glucose monitoring, post-operative patients can be divided in two broad categories.

DRUG

Actrapid insulin

On admission to hospital all pre-operative oral antidiabetic agents and insulin are stopped and glucose monitoring is carried out every four hours at the same time as routine observations. Actrapid insulin is administered as per standard sliding scales (appendix A). Just prior to discharge, total insulin administered over the previous 24 hour post-operative period is calculated. Based on the results of ward based glucose monitoring patients are discharged home on metformin 1000mg BID and/or the equivalent amount of Glargine insulin requirement in previous 24 hours prior to discharge.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Carel W Le Roux, MD, PhD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01213563 on ClinicalTrials.gov