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

NCT02041234 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-06-23

No results posted yet for this study

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.

Conditions

  • Type II Diabetes in Subjects BMI 27 to 32

Interventions

PROCEDURE

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.

DRUG

Incretin analogues

Incretin analogues: Liraglutide up to 1.8 mg daily

DRUG

Xenical

Xenical: Up to 120 mg tds

DRUG

SGLT2 inhibitors

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

DRUG

DPP-4 Inhibitors

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

Sponsors & Collaborators

  • Khoo Teck Puat Hospital

    lead OTHER

Principal Investigators

  • Anton Cheng, MBBS · Khoo Teck Puat Hospital

  • Su Chi Lim, MBBS, PhD · Khoo Teck Puat Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2020-12-31
Completion
2022-06-30

Countries

  • Singapore

Study Locations

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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 NCT02041234 on ClinicalTrials.gov