The Effects of Glycemic Optimization Before Gastric Bypass Surgery

NCT01353118 | Completed Results DMC

• 1 other identifier: GLUCOSURG 2
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

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

Conditions

Type 2 Diabetes

Keywords

diabetes; bariatric surgery; Roux-en-y gastric bypass; retinopathy; neuropathy; nephropathy

Outcome Measures

Primary Outcomes (1)

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

  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

  1 year

Secondary Outcomes (1)

• A Composite of Microvascular Complications

  1 year

Study Arms (2)

gastric bypass

NO INTERVENTION

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

Gastric bypass 2

ACTIVE COMPARATOR

Gastric bypass 2 (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 in a gradual manner with particular attention to the avoidance of hypoglycaemia

Biological: gastric bypass

Interventions

gastric bypass BIOLOGICAL

Optimise glucose control within 3 months before operation

Also known as: Type 2 diabetes, glucose optimisation, microvascular complications, retinopathy, neuropathy, nephropathy, Gastric bypass with

Gastric bypass 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• End stage retinopathy, nephropathy or neuropathy.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Imperial Weight Centre, Charing Cross Hospital,

London, W6 8FR, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Retinal Diseases; Kidney Diseases

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Eye Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Results Point of Contact

• Title: Carel le Roux
• Organization: Imperial College

c.leroux@imperial.ac.uk

07970719453

Study Officials

• Carel Le Roux, MBChB, PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant metabolic medicine

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: May 12, 2011
• Study Start: May 1, 2011
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 14, 2022
• Results First Posted: March 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)