E11.74 I70.2
Conditions
Interventions
Group 1: Individuals with a defined indication for major ampulation of the lower limb
Sponsors
Universitätsklinikum Heidelberg, Klinik für Endokrinologie, Diabetologie, Stoffwechselkrankheiten und klinische Chemie
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Participants with a defined indication for amputation Ability to provide informed consent, understand the explanations about the study, and follow instructions Individuals with manifest type 1 or type 2 diabetes mellitus, with a confirmed diagnosis according to the 2011 DDG criteria (i.e., HbA1c = 6.5% excluding factors that could distort HbA1c results, = 200 mg/dl 2-hour value during an oral glucose tolerance test (oGTT), pathological fasting glucose = 126 mg/dl, or at least two pathological random glucose readings of = 200 mg/dl), or Participants without diabetes or any glucose metabolism disorder, as confirmed by an oral glucose tolerance test (oGTT) according to the 2011 DDG criteria: fasting venous plasma glucose < 100 mg/dl and 2-hour venous plasma glucose < 140 mg/dl, or Individuals with prediabetes, characterized by impaired fasting glucose between 100 mg/dl and 125 mg/dl or impaired glucose tolerance with a 2-hour oGTT value between 140-199 mg/dl (venous), or HbA1c levels between 5.7% and 6.4%.
Exclusion criteria
Exclusion criteria: HbA1c >10% Secondary causes of diabetes mellitus Other causes of peripheral polyneuropathy Severe autoimmune diseases Immunomodulating therapy Known severe psychiatric illnesses requiring treatment (e.g., personality disorders, schizophrenia, depression) Known dependency on alcohol or other drugs Known malignant cancer diagnosis within the past 5 years Current participation in another interventional study Exclusion criteria for MRI: Pacemaker / ICD Metallic and magnetic implants (e.g., mechanical heart valves, joint prostheses, vascular clips, middle or inner ear implants, recent dental implants, penile implants) Waist circumference >135 cm Claustrophobia Known allergy to MRI contrast agents GFR (CKD-EPI) < 60 ml/min/1.73 m² Exclusion criteria for BIA measurement: Pacemaker / ICD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this study is to gain insights into the histological and molecular changes in various tissues obtained after lower limb amputation in individuals with type 2 diabetes (T2D). | — |
Secondary
| Measure | Time frame |
|---|---|
| DNA damage and the senescence cascade in sarcopenia within muscle tissue. | — |
Countries
Germany
Contacts
Public ContactZoltan Kender
Universitätsklinikum Heidelberg, Klinik für Endokrinologie, Diabetologie, Stoffwechselkrankheiten und klinische Chemie
Outcome results
None listed