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NCT Number: NCT01353118

The Effects of Glycemic Optimization Before Gastric Bypass Surgery

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charing Cross Hospital, London, United Kingdom

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About this study

This is a prospective study involving 150 patients with type 2 diabetes mellitus (T2DM) and obesity. One hundred patients will undergo gastric bypass surgery whilst 50 will be treated with best medical care. The surgical patient group will be randomised to either immediate surgery or 3 months of medical glycaemic optimisation followed by surgery (n=50 group).

Intervention Group A: Patients will undergo gastric bypass surgery within 3 months after randomisation without any pre operative optimisation of glycaemic control.

Group B: Patients will undergo gastric bypass 3-6 months after randomisation. During this period the group will receive modern best medical care based on the American Diabetes Association (ADA)/European Association for the Study of Diabetes (EASD) guidelines. Glycaemic optimisation will be achieved with particular attention to the avoidance of hypoglycaemia.

Group C: Obese patients with T2DM (who choose not to have surgery) will be treated with best medical care based on the ADA/EASD guidelines including anti-diabetes/obesity pharmacotherapy, access to a trained dietician and exercise programme.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients with T2DM and BMI above 35kg/m2
  • HbA1c ≥ 8.5% and/or the presence of at least one microvascular complication.

Exclusion criteria

  • End stage retinopathy, nephropathy or neuropathy.

Treatment and study plan

gastric bypass

Biological

Optimise glucose control within 3 months before operation

Other names: Type 2 diabetes, glucose optimisation, microvascular complications, retinopathy, neuropathy, nephropathy, Gastric bypass with

Primary outcomes

  1. Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission.

    Time frame: 1 year

    A patient is considered to have achieved remission of T2F according to the American Diabetes Association criteria if they have fasting glucose below 6mmol/L AND HbA1c below 6% AND no medication for diabetes. Thus, a patient needs to achieve all of the three criteria (fasting glucose, HbA1C, and no medication) before being considered to be in remission. If a patient only achieves 2 of the criteria (fasting glucose and no medication) but the HbA1C is above 6% then they are not considered to be in remission.

    The outcome measure is calculated as the count of participants achiving the above criteria

Secondary outcomes

  1. A Composite of Microvascular Complications

    Time frame: 1 year

    A composite of microvascular complications. Microvascular events will be defined as new or worsening nephropathy, retinopathy or neuropathy.

    The outcome measure is calculated as the count of participants developing any of the microvascular events.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Investigation of the Effects of Glycaemic Optimisation Before Gastric Bypass Surgery on the Glycaemic Remission and Microvascular Complication Rates of Type 2 Diabetes Mellitus

Acronym: GLUCOSURG2

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 12, 2011
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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