Efficacy and costs of Roux-en-Y gastric bypass surgery versus conventional treatment of type 2 diabetes patients with a BMI > 35 kg/m2: a prospective randomized controlled trial

Efficacy and costs of Roux-en-Y gastric bypass surgery versus conventional treatment of type 2 diabetes patients with a BMI > 35 kg/m2: a prospective randomized controlled trial - RCT in DM2 patients with BMI >35 kg/m2: RYGB vs conventional therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34324

Enrollment

100

Registered

2010-12-06

Start date

2011-03-01

Completion date

Unknown

Last updated

2024-09-30

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

Conditions

diabetes type 2 sugar disease

Interventions

RYGB surgery versus conventional therapy for DM2 (NHG standaard) and obesity (CBO guideline)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Informed consent • Age 18-60 years • DM2 . fasting c-peptide > 0.8 ng/ml • HbA1c > 7.0 % despite diet/lifestyle advises and 2 glucose-lowering drugs with the exception of insulin • BMI> 35 kg/m2 and

Exclusion criteria

Exclusion criteria: • Use of insulin • Substance abuse/dependence • Mentally instable/psychiatric disorder (according to evaluation psychologist) • Some eating disorders . no diabetes type 2, fasting c-peptide

Design outcomes

Primary

Measure	Time frame
Difference between the intervention groups in HbA1c, percentage with Hba1c	—

Secondary

Measure	Time frame
quality of life, body weight, cardiovascular risk factors and 10-year cardiovascular risk.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)