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.

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. - IsoOx

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033287

Enrollment

Registered

2024-01-11

Start date

2024-05-14

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Prediabetes C61

Interventions

Group 1: Control group (Cohort 1) The study participation extends over a period of eight weeks. Cohort 1 participants must visit the study center once a week to have a blood sample taken. In the first

Eligibility

Sex/Gender

Male

Age

45 Years to 80 Years

Inclusion criteria

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

Exclusion criteria: Women BMI for Cohort 1 29,5 HbA1c : Cohort 1 > 5,7%, Cohort 2 >5,7% and 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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. 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. Finally, dietary data will be collected to associate the intake of micro- and macronutrients as well as antioxidants with the level of oxidative stress.	—

Measure

Time frame

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. 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. Finally, dietary data will be collected to associate the intake of micro- and macronutrients as well as antioxidants with the level of oxidative stress.

—

Countries

Germany

Contacts

Public ContactMelissa Solano Marchini

Institut für Diabetologie und klinische Stoffwechselforschung, UKSH Kiel

melissa.solanomarchini@uksh.de+49 431 500-22448

Outcome results

None listed

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