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Surgical therapy for reduction of metbolic dysfunction

Surgical therapy for reduction of metbolic dysfunction - ChARMeD

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00028484
Enrollment
2000
Registered
2022-03-08
Start date
2022-04-04
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

obesity, diabetes mellitus type 2, non-alcoholic fatty liver disease E65-E68

Interventions

Group 1: Patients with obesity grade II and grade III with/without type 2 diabetes mellitus before and after bariatric surgery. Examinations will be performed before bariatric surgery and after surger

Sponsors

Universitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
Change in insulin sensitivity, energy metabolism and lipid metabolism in liver, skeletal muscle and adipose tissue after bariatric surgery.

Secondary

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

Countries

Germany

Contacts

Public ContactAlba Sulaj

Universitätsklinikum Heidelberg

Alba.Sulaj@med.uni-heidelberg.de+4962215639826

Outcome results

None listed

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