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Efficacy of Laparoscopic Roux-en-Y Gastric Bypass Surgery versus Conventional Therapy for Type 2 Diabetes Mellitus in Moderate Obese Patients with BMI of 30 -35 kg/m2: a randomized controlled trial.

Efficacy of Laparoscopic Roux-en-Y Gastric Bypass Surgery versus Conventional Therapy for Type 2 Diabetes Mellitus in Moderate Obese Patients with BMI of 30 -35 kg/m2: a randomized controlled trial. - ROMEO-trial

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40441
Enrollment
40
Registered
2014-01-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Obesitas Obesity overweight

Interventions

The patients will be randomized in the intervention group (RYGB) or the control group (conventional therapy group).

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Informed consent 2. Age 18 * 50 years 3. BMI 30-35 kg/m2 4. Medical history of DM2 a. Metformin + (SU-derivate/DPP4-remmer) b. Insulin dependent; with or without oral diabetic medication c. GLP-1 analogue; with or without oral diabetic medication 5. HbA1c > 7.0% and Fasting Plasma Glucose (FPG) > 7.9 mmol/L

Exclusion criteria

Exclusion criteria: 1. No diabetes 2. History of bariatric surgery 3. C-peptide

Design outcomes

Primary

MeasureTime frame
Complete remission of DM2 defined as FPG—

Secondary

MeasureTime frame
Improvement of HbA1c: HbA1c difference of 1% (or 11 mmol/mol; SD 1.5% or 16.5 mmol/mol), and Achievement of HbA1c target of 2.5 g/mol for men and > 3.5 g/mol for women); surgical complication rate: such as anastomotic leakage, bleeding, wound infection, trombo-embolic events, internal hernia; vitamin deficiencies: vitamin D, vitamin B12, folate.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)