Roux-en-Y Gastric Bypass for BMI 27-32 Type 2 Diabetes Versus Best Medical Treatment

NCT ID: NCT02041234

Last Updated: 2022-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2022-06-30

Brief Summary

Investigators aim to show that Roux-en-Y Gastric Bypass (RYGB) is superior to best medical treatment in reaching well-defined treatment end points in Asian subjects of BMI 27-32 with type 2 Diabetes (DM2). Investigators also hope to show that successful RYGB will reduce resource utilization in the near term with similar projected reduction over the medium to long term.

Detailed Description

40 subjects with DM2 will be recruited, randomised into two arms. The surgical arm will be subjected to RYGB. The medical arm will be treated maximally utilising the best means available and following internationally available protocol/guidelines. The study population will be subjected to a set of tests which is over and above the standard tests for similar groups of patients undergoing standard care (details below). Some test samples will be bio-banked. Treatment end points and follow up protocol will be the same for each treatment arm. The International Diabetic Federation (IDF) in 2011 recommended that bariatric surgery should be considered an alternative treatment option for those Asian DM2 subjects with BMI of 27 or above. Data for the effectiveness of Bariatric Surgery for those DM subjects with lower BMI is not as well established as those with higher BMI. There is scant good quality data, especially from Asian subjects. As their treatment is totally funded by the research project, subjects on the non surgical treatment arm will benefit from the more intense management of their disease with no restriction due to cost. The surgical arm will also be fully funded by the research project. They will be exposed to the standard risks associated with this type of surgery. Subjects in both arms will have to provide more blood and other samples than usual and has to follow visits protocol as close as possible. RYGB is a major surgical procedure, with significant potential complications; during the process of surgery and afterwards, both short and long term. Procedure related mortality is about 0.3%. Major complications that may require surgical intervention includes: anastomotic leakage about 3-4%, bleeding 3%, infection 3%, venous thrombo-embolism 1%. Some of these complications will require prolong hospitalisation. After surgery, loose stool, dumping syndrome, anastomotic ulcers can occur in less than 3%.Life long dietary supplement will be required. Longer term post surgical complications include intestinal obstruction due to adhesions or internal hernia, about 2%, further surgery may be needed. This risk is lifelong. Nutritional deficiencies, especially if not compliant with regular supplement intake, may occur. Drug allergies can occur; from simple rash to life threatening anaphylactic reaction. Blood taking can cause bruising, pain at the puncture site and sometimes fainting.

Conditions

Type II Diabetes in Subjects BMI 27 to 32

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Roux-en-Y Gastric Bypass (RYGB)

Roux-en-Y Gastric Bypass (RYGB) as per standard surgical protocol, with a 30 cc gastric pouch, 50 cm biliopancreatic limb and 100cm gastrointestinal limb.

Group Type: ACTIVE_COMPARATOR

Roux-en-Y Gastric Bypass (RYGB)

Intervention Type: PROCEDURE

Roux-en-Y Gastric Bypass (RYGB) as per standard surgical protocol, with a 30 cc gastric pouch, 50 cm biliopancreatic limb and 100cm gastrointestinal limb.

Best Medical Treatment

Anti-diabetic medications provided (Mono- or Combination- therapy):

Incretin analogues: Liraglutide up to 3 mg daily Or DPP-4 Inhibitors: Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily Xenical: Up to 120 mg tds SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily Participants will also take lipids & BP medications according to standard of care.

Group Type: ACTIVE_COMPARATOR

Incretin analogues

Intervention Type: DRUG

Incretin analogues: Liraglutide up to 1.8 mg daily

Xenical

Intervention Type: DRUG

Xenical: Up to 120 mg tds

SGLT2 inhibitors

Intervention Type: DRUG

SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily

DPP-4 Inhibitors

Intervention Type: DRUG

Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily

Interventions

Roux-en-Y Gastric Bypass (RYGB)

Roux-en-Y Gastric Bypass (RYGB) as per standard surgical protocol, with a 30 cc gastric pouch, 50 cm biliopancreatic limb and 100cm gastrointestinal limb.

Intervention Type: PROCEDURE

Incretin analogues

Incretin analogues: Liraglutide up to 1.8 mg daily

Intervention Type: DRUG

Xenical

Xenical: Up to 120 mg tds

Intervention Type: DRUG

SGLT2 inhibitors

SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily

Intervention Type: DRUG

DPP-4 Inhibitors

Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily

Intervention Type: DRUG

Other Intervention Names

Liraglutide; Orlistat; Empagliflozin; Canagliflozin; Sitagliptin; Linagliptin

Eligibility Criteria

Inclusion Criteria

1. Established diagnosis of DM2 = or < 10 years

2. Age 21-65

3. BMI 27-32.

4. HBA1c ≥ 8%, on maximum treatment from primary care physician

5. At least one of the following co-morbidities on treatment: hypertension, hyperlipidaemia, micro/macro-proteinuria or ≤class I nephropathy, retinopathy.

Exclusion Criteria

1. Subjects who had previous Bariatric surgery or extensive upper abdominal surgery

2. Pregnant subjects.

3. Nephropathy requiring dialysis

4. Subjects who are not fit for general anaesthesia.

5. Subjects who are unsuitable for RYGB for whatever reason, medical/surgical/psychological.

6. Subjects who are unwilling or possibly unable to participate in the follow up process.

7. Subjects who are reluctant to be randomised into the two study groups.

8. Subjects who suffers from unstable psychiatric illness

9. Subjects who are active substance abusers

10. Glutamic acid decarboxylase antibody positive.

11. fasting C-peptide < 300 pmol/L

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khoo Teck Puat Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anton Cheng

Dr Anton Cheng

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anton Cheng, MBBS

Role: PRINCIPAL_INVESTIGATOR

Khoo Teck Puat Hospital

Su Chi Lim, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

Khoo Teck Puat Hospital

Locations

Khoo Teck Puat Hospital

Singapore, , Singapore

Countries

Singapore

References

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Cheng A, Yeoh E, Moh A, Low S, Tan CH, Lam B, Sum CF, Subramaniam T, Lim SC. Roux-en-Y gastric bypass versus best medical treatment for type 2 diabetes mellitus in adults with body mass index between 27 and 32 kg/m2: A 5-year randomized controlled trial. Diabetes Res Clin Pract. 2022 Jun;188:109900. doi: 10.1016/j.diabres.2022.109900. Epub 2022 May 2.

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Other Identifiers

Bariatric Surgery RCT

Identifier Type: -

Identifier Source: org_study_id