Compared Investigation of inflammation and hyperglycemia associated molecular Signalling in Human Tissues (Patients with Sepsis, Diabetes mellitus type 2 and Metabolic Syndrome)

Compared Investigation of inflammation and hyperglycemia associated molecular Signalling in Human Tissues (Patients with Sepsis, Diabetes mellitus type 2 and Metabolic Syndrome) - INSIGHT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005450

Enrollment

200

Registered

2014-04-14

Start date

2009-02-01

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

K76.0 E11.90 R65.0 R65.1 R57.2

Interventions

Group 1: Patients suffering from sepsis/septic Shock (supposed abdominal focus), with or without pre-existent type 2 diabetes mellitus: anamnesis, anthropometry (body weight, height, BMI, waist and b

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: For all study patients in general: - written informed consent - indication for open laparotomy - age = 18 years Patients with sepsis/septic Shock: - written informed consent - Suspected sepsis or septic shock (in accordance with the S2-Sepsis-Guideline) - in case of re-laparotomy: last surgical intervention after = 5 days Patients with type 2 diabetes mellitus, metabolic syndrome (incl. NAFLD): - meeting the criteria for diagnosis of metabolic syndrome (NCEP ATP III-Panel-Criteria, S1-Guideline NAFLD) or meeting the criteria for diagnosing of type 2 diabetes mellitus (ADA 2010) or known therapy of type 2 diabetes mellitus - diagnostic criteria of SIRS/sepsis/septic shock are not applicable Patients without type 2 diabetes mellitus /metabolic syndrome or sepsis/septic shock: - NCEP ATP III-Panel or ADA 2010 criteria not applicable, no pre-existing type 2 diabetes mellitus - criteria for diagnosing SIRS/sepsis/septic shock not applicable

Exclusion criteria

Exclusion criteria: For all study patients in general: - Chemotherapy within the last 2 month - long-term treatment with immune-suppressive medication - status after organ transplantation - treatment of any chronic or acute active rheumatoid inflammatory disease - drug abuse - preexisting chronic kidney insufficiency/failure with essential hemodialysis - liver cirrhosis

Design outcomes

Primary

Measure	Time frame
- Molecular signaling patterns that have been reported to be related to insulin resistance and inflammation in animal and experimental models (i.e. ER-Stress-Pathway, AMPK, specific cellular carboxylate transporters (i.e. SLC13A5), Autophagy and others. - Correlation analysis with related clinical parameters (i.e. clinical chemistry) and clinical endpoints (insulin resistance, histopathological variables; associations with morbidity in sepsis patients using validated clinical scores of illness severity, i.e. SOFA, SAPS, APACHE, and 30 day mortality).We will further analyze the different B cell subsets and their function in sepsis response in human with a focus on IRS b cells. Moreover by using a translational setting we aim to approve the clinical relevance of the Hox-gene fragment modulation in terms of increasing the regenerative potential of skeletal muscle in sepsis. - Identification of potential pharmacological targets	—

Measure

Time frame

- Molecular signaling patterns that have been reported to be related to insulin resistance and inflammation in animal and experimental models (i.e. ER-Stress-Pathway, AMPK, specific cellular carboxylate transporters (i.e. SLC13A5), Autophagy and others. - Correlation analysis with related clinical parameters (i.e. clinical chemistry) and clinical endpoints (insulin resistance, histopathological variables; associations with morbidity in sepsis patients using validated clinical scores of illness severity, i.e. SOFA, SAPS, APACHE, and 30 day mortality).We will further analyze the different B cell subsets and their function in sepsis response in human with a focus on IRS b cells. Moreover by using a translational setting we aim to approve the clinical relevance of the Hox-gene fragment modulation in terms of increasing the regenerative potential of skeletal muscle in sepsis. - Identification of potential pharmacological targets

—

Secondary

Measure	Time frame
- Identification of differences vs. comparable molecular signaling patterns regarding insulin resistance and sepsis/septic shock - Correlation of the targets of interest with clinical parameters	—

Countries

Germany

Contacts

Public ContactChristian von Loeffelholz

Universitätsklinikum Jena Klinik für Anästhesiologie und Intensivtherapie

christian.von_loeffelholz@med.uni-jena.de03641/9323128

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 27, 2026