The interaction of oxidative stress with the isotopic ratios of trace elements in the human body and their potential application for the early detection of chronic diseases.

Recruiting

Conditions: Prediabetes
C61
Malignant neoplasm of prostate

Registration Number: DRKS00033287

Lead Sponsor: Institut für Diabetologie und klinische Stoffwechselforschung, UKSH Kiel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 45

Inclusion Criteria

Cohort 1: Age 45-65, BMI 18,5 – 29,5 und HbA1c < 5,7%
Cohort 2: Age 45-65, BMI 18,5 – 39,9 und HbA1c 5,7% bis < 6,5%
Cohort 3: Age 45-80, BMI 18,5 – 34,5 , HbA1c < 6,5%, Histologically confirmed prostate cancer and Planned radiotherapy of the prostate +/- seminal vesicles with 20x3 Gy.

Exclusion Criteria

Women
BMI for Cohort 1 <18,5 – >29,5
HbA1c : Cohort 1 > 5,7%, Cohort 2 >5,7% and < 6,5%, Cohort 3 > 6,5%
Smoker
Alcoholic
Drug dependencies
Antibiotic intake in the last 8 weeks
Last blood donation less than 2 months ago
Surgery performed less than 4 weeks ago
Only for Cohort 1: Diagnosis of at least one metabolic/endocrine disease

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
With this pilot study, the foundation for the development of a quantitative, comparable method for measuring oxidative stress using isotopic fractionation of metals is intended to be established. The study identifies the general variation of isotopic values among the subjects as well as the differences between the cohorts, aiming to allow initial statements regarding the sensitivity/specificity of the method. Furthermore, the goal is to establish threshold values for a 'normal' isotopic signature.

Secondary Outcome Measures

Name	Time	Method
During the study, other parameters that have already been validated to determine the presence of oxidative stress will be used to compare the outcomes of the isotopic analysis. These parameters include 8-Hydroxydeoxyguanosine (8-OHdG), advanced glycated end products, and the indirect measurement of hydroperoxide in blood through the FORT Test.<br><br>For Cohorts 1 and 2, subjects will be recruited from a previous epidemiological study, the FoCus Cohort (Geisler, C et al, 2022). A secondary outcome for these groups will be the association of longitudinal data from these subjects with the isotopic signature of the IsoOx Study.<br><br>Finally, dietary data will be collected to associate the intake of micro- and macronutrients as well as antioxidants with the level of oxidative stress.