Metabolic Surgery for Type 2 Diabetes within BMI range of 27 to 60 kg/m²

Not Applicable

Recruiting

• Conditions: E11; E66.0; Type 2 diabetes mellitus; Obesity due to excess calories

• Registration Number: DRKS00007810
• Lead Sponsor: niversitätsklinikum Leipzig AöRKlinik u. Poliklinik für Visceral-, Transplantations-, Thorax- u. Gefäßchirurgie Bereich Bariatrische Chirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

BMI =27 to =60 kg/m²;
- for BMI=35: any Diabetes mellitus type 2;
- for BMI < 35 kg/m²: Diabetes mellitus type 2 with unsatisfactory medical non-insulin treatment (multiple medications, HbA1c >6.5%, hypo- or hyperglycaemias), or planned insulin treatment or ongoing insulin Treatment;
- written informed consent

Exclusion Criteria

- any chronic inflammatory or malignant disease; - type 1 diabetes; - peptic ulcer; - contraindication for general anaesthesia; - drug or alcohol abuse; - untreated thyroid dysfunction; - pregnancy or breast feeding woman; - expected non-compliance; - participation in other interventional trials requiring insurance

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c value after one year

Secondary Outcome Measures

Name	Time	Method
Remission rate of diabetes mellitus type 2 (HbA1c<6.5% without any antidiabetic medication) after one year<br>