NCT01213563

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

1.7 years

First QC Date

October 1, 2010

Last Update Submit

August 19, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • efficacy and safety of an intensive glycaemic protocol after bariatric surgery

    insulin+Gloucose

    1 year

Study Arms (2)

Actrapid insulin

EXPERIMENTAL

Intensive glycaemic control Intervention: Actrapid insulin

Drug: Actrapid insulin

Actrapid insulin+Gloucose

ACTIVE COMPARATOR

conventional glycaemic control Intervention: Actrapid insulin+Glucose

Drug: Actrapid insulin+Gloucose

Interventions

Actrapid insulin+GloucoseDRUG

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.

Also known as: insulin+Gloucose
Actrapid insulin+Gloucose
Actrapid insulinDRUG

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.

Also known as: insulin
Actrapid insulin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London, Charing Cross Hospital

London, W68NA, United Kingdom

Location

Related Publications (1)

  • Fenske WK, Pournaras DJ, Aasheim ET, Miras AD, Scopinaro N, Scholtz S, le Roux CW. Can a protocol for glycaemic control improve type 2 diabetes outcomes after gastric bypass? Obes Surg. 2012 Jan;22(1):90-6. doi: 10.1007/s11695-011-0543-6.

    PMID: 22052198DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin, neutralInsulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Carel W Le Roux, MD, PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

January 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

August 21, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)