Management of Type 2 Diabetes After Gastric Bypass Surgery

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01213563
First received: October 1, 2010
Last updated: October 18, 2010
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
Gastric Bypass
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Enrollment: 50
Study Start Date: January 2009
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Intensive glycaemic control and conventional glycaemic control

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study was a prospective study including morbidly obese patients with insulin-requiring type 2 diabetes immediately following gastric bypass surgery.

On admission to hospital patients' regular oral hypoglycaemic medication and insulin were stopped, and short-acting insulin was given based on capillary glucose monitoring according to a routine care insulin sliding scale.

Upon discharge 2-3 days after surgery, patients were prescribed metformin 1g twice daily and glargine at a dose equivalent to the insulin requirement during the 24 hours prior to discharge. Patients were instructed to contact the metabolic physician every day via text(SMS) message or telephone to report fasting capillary blood glucose levels obtained using Accu-Check Advantage. Based on the reported glucose values insulin dosages were then adjusted daily according to a titration schedule.

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
  More Information

No publications provided by Imperial College London

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Carel W. Le Roux, Imperial Weight Centre, Imperial College London
ClinicalTrials.gov Identifier: NCT01213563     History of Changes
Other Study ID Numbers: ImperialC
Study First Received: October 1, 2010
Last Updated: October 18, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by Imperial College London:
feasibility, safety and efficacy of an intensive treatment algorithm for patients with type 2 diabetes mellitus after gastric bypass surgery.

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 19, 2014