Management of Type 2 Diabetes After Gastric Bypass Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01213563
First received: October 1, 2010
Last updated: February 26, 2016
Last verified: October 2010
  Purpose
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.

Condition Intervention
Diabetes Mellitus, Type 2
Drug: Actrapid insulin+Gloucose
Drug: Actrapid insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Protocol Driven Management of Type 2 Diabetes After Gastric Bypass Surgery

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • efficacy and safety of an intensive glycaemic protocol after bariatric surgery [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: insulin+Gloucose

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213563

Locations
United Kingdom
Imperial College London, Charing Cross Hospital
London, United Kingdom, W68NA
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Carel W Le Roux, MD, PhD Imperial College London
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01213563     History of Changes
Other Study ID Numbers: 09/808 
Study First Received: October 1, 2010
Last Updated: February 26, 2016
Health Authority: United Kingdom: National Health Service
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Imperial College London:
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin, neutral
Insulin
Insulin, Regular, Pork
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016