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The Effects of Glycemic Optimization Before Gastric Bypass Surgery

NCT01353118 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2022-03-14

Study results available
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Summary

Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations can cause rapid and uncontrolled reductions in blood glucose. There is limited information on whether:

* metabolic surgery is superior to modern medical care for glycaemic control and type 2 diabetes remission.
* metabolic surgery is safe for microvascular complications of Type 2 diabetes
* good glycaemic control pre surgery has any effects on the long term glycaemia and complications of type 2 diabetes.

This study aims to assess:

1. whether metabolic surgery is better for diabetes control compared to medical treatment.
2. whether metabolic surgery is safe for eye, nerve and kidney complications.
3. whether good sugar control before metabolic surgery improves the long term effects of sugar control and microvascular complications.

Conditions

Interventions

BIOLOGICAL

gastric bypass

Optimise glucose control within 3 months before operation

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Carel Le Roux, MBChB, PhD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT01353118 on ClinicalTrials.gov