Metabolic surgery for body mass index (BMI) < 27 kg/m2 patients with type 2 diabetes mellitus

Metabolic surgery for body mass index (BMI) < 27 kg/m2 patients with type 2 diabetes mellitus: early results

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56897851

Enrollment

Registered

2011-10-18

Start date

2009-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Mellitus Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

Surgery, Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years 2. BMI 7.0%

Exclusion criteria

Exclusion criteria: 1. Patients younger than 18 or older than 65 years 2. Those planning pregnancy in next 2 years 3. Patients with type 1 diabetes mellitus (T1DM) 4. Latent autoimmune diabetes in adults 5. Malignancy 6. Debilitating disease 7. Unresolved psychiatric illness 8. Substance abuse 9. American Society of Anesthesiologists (ASA) classification > III

Design outcomes

Primary

Measure	Time frame
1. Remission of T2DM, defined by HbA1c < 6.5% without oral hypoglycemic drugs or insulin 2. Glycemic control, defined as HbA1C of < 7 % despite no use of anti-diabetic medications 3. Improvement of T2DM, defined as a reduction of at least 25% in the fasting plasma glucose level and/ or at least 1% in the pre-operative HbA1c level with hypoglycemic drug treatment 4. Failure of surgical procedure, defined as no significant improvement or worsened if a patient required an additional anti-diabetic meditation	—

Measure

Time frame

1. Remission of T2DM, defined by HbA1c < 6.5% without oral hypoglycemic drugs or insulin 2. Glycemic control, defined as HbA1C of < 7 % despite no use of anti-diabetic medications 3. Improvement of T2DM, defined as a reduction of at least 25% in the fasting plasma glucose level and/ or at least 1% in the pre-operative HbA1c level with hypoglycemic drug treatment 4. Failure of surgical procedure, defined as no significant improvement or worsened if a patient required an additional anti-diabetic meditation

—

Secondary

Measure	Time frame
1. Resolution of co-morbities 2. Complications related to procedure	—

Countries

Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026