Management of Type 2 Diabetes After Gastric Bypass Surgery

August 19, 2020 updated by: Imperial College London

Protocol Driven Management of Type 2 Diabetes After Gastric Bypass Surgery

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomised controlled intervention study on obese human subjects with Type 2 Diabetes Mellitus undergoing obesity surgery (n=80). Patients will be recruited from those already due to undergo bariatric surgery within the context of the obesity clinic (Imperial College London). Patients will be randomised to either of two treatment protocols.

Protocol A-Conservative Management: 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 with glucose 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.

The first group includes patients who are able to maintain euglycaemia without exogenous insulin administration. These patients are discharged home on their preoperative Metformin dose and are advised to continue monitoring their fasting glucose levels at home. If fasting glucose levels of less than 4 or more than 10mmol/l are recorded at home, the patients are encouraged to contact the obesity clinic physicians for advice.

The second group includes patients experiencing hyperglycemic episodes in the immediate post-operative period. These patients are discharged home on their preoperative Metformin dose and once daily insulin Glargine as decided by the discharging doctor (or based on half their last 24 hour requirements) and are advised to continue monitoring their fasting glucose levels at home. If fasting glucose levels of less than 4 or more than 10mmol/l are recorded at home, the patients are encouraged to contact the obesity clinic physicians for advice.

Protocol B-Intensive management: 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. These patients are also advised to continue glucose monitoring at home and will be contacted every day and their medication adjusted to maintain a fasting glucose between 5 and 7mmol/l. When this is consistently achieved the investigators will stop calling, but patients will be encouraged to continue monitoring their blood sugars and contact the investigators should they experience any problems with their glycaemic control.

Venesection will take place at 10 days, 3, 6 and 12 months post-operatively and yearly thereafter for fasting glucose and HbA1c as part of the routine care of patients of the obesity clinic. As part of clinical management we will ensure that all patients with diabetes will have a kidney (2 samples of morning urine albumin creatinine ratio), nerve (nerve conduction study, including thermal threshold testing) and eye (retinal photograph) tests once before and within 1, 2 and 3 years after surgery. These tests are all non invasive and except from the nerve tests are performed routinely for all patients with diabetes at least yearly and if performed in the community they will not be repeated.Therefore, other than the nerve conduction studies, there will be no extra burden to the patients as a result of the study.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W68NA
        • Imperial College London, Charing Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI) > 35,
  • Insulin-requiring T2DM,
  • Age >18yr,
  • Having undergone gastric bypass surgery,
  • HbA1C >8%

Exclusion Criteria:

  • Non-insulin requiring T2DM,
  • HbA1C <8%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Actrapid insulin
Intensive glycaemic control Intervention: Actrapid insulin
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.
Other Names:
  • insulin
Active Comparator: Actrapid insulin+Gloucose
conventional glycaemic control Intervention: Actrapid insulin+Glucose
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.
Other Names:
  • insulin+Gloucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy and safety of an intensive glycaemic protocol after bariatric surgery
Time Frame: 1 year
insulin+Gloucose
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Carel W Le Roux, MD, PhD, Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

October 1, 2010

First Posted (Estimate)

October 4, 2010

Study Record Updates

Last Update Posted (Actual)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09/808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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