Surgical therapy for reduction of metbolic dysfunctio

Recruiting

• Conditions: obesity, diabetes mellitus type 2, non-alcoholic fatty liver disease; E65-E68; Obesity and other hyperalimentation

• Registration Number: DRKS00028484
• Lead Sponsor: niversitätsklinikum Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Age = 20 and = 70 years, BMI 35-39.9 kg/m² (obesity grade II), > 40kg/m² (obesity grade III), capacity to consent, presence of informed consent as per consent form

Exclusion Criteria

Acute infections (CRP > 5 mg/dl, body temperature > 37.5 °C), autoimmune diseases and immunocompromising diseases, renal insufficiency (creatinine > 1.5 mg/dl), severe chronic diseases, anemia (Hb < 12g/l for males, Hb < 11g/l for females, control on each examination day), participation in another intervention study within 2 months prior to the examination, intake of immunomodulatory medications (e.g. oral cortisone preparations, biologicals), medication with antithrombotic drugs, thyroid disease with unstable metabolic status (change in L-thyroxine dose within the last 6 weeks, TSH and fT4 outside the normal range), pregnancy, lactation period, previous/current alcohol and/or drug abuse, HIV, hepatitis B or C disease, liver disease not attributed to the presence of nonalcoholic fatty liver disease, night shift work or circumstances that do not allow a normal day-night rhythm, blood clotting or wound healing disorders or positive history of venous thrombosis, hypersensitivity to local aesthetics, malignant tumor disease or tumor treatment within the last 5 years (with the exception of malignant skin diseases that were treated curatively), contraindications for an MRI examination (metallic implants, claustrophobia, etc.) (relative exclusion criterion).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity, energy metabolism and lipid metabolism in liver, skeletal muscle and adipose tissue after bariatric surgery.

Secondary Outcome Measures

Name	Time	Method
Detailed characterization of metabolically ill obese individuals, particularly with respect to mitochondrial function in liver, skeletal muscle, and adipose tissue.