Dietary Antioxidants and Thiol Disulfide Homeostasis in T2DM

NCT05688631 | Completed

• 1 other identifier: AnkaraYBU-KARAKAYA001
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study was planned to determine the relationship between dietary antioxidant intake and thiol disulfide homeostasis of individuals with type 2 diabetes. One of the current approaches in medical nutrition therapy of diabetes is to increase the consumption of foods with high antioxidant content in order to strengthen antioxidant defense. Increased dietary antioxidant intake may have both protective and therapeutic effects by reducing the risk of diabetes and preventing complications that may occur. It is known that dynamic thiol disulfide balance can be a good indicator of antioxidant defense in individuals with diabetes, and there are limited studies on this subject.

Conditions

Diabetes Mellitus, Type 2; Antioxidative Stress

Keywords

Diabetes mellitus; Dietary antioxidants; Oxidative stress; Thiol disulfide homeostasis

Outcome Measures

Primary Outcomes (7)

• Serum native thiol level

  serum native thiol level in μmol/L

  Baseline (preprandial in the morning)

• Serum disulphide level

  serum disulphide level in μmol/L

  Baseline (preprandial in the morning)

• Serum total thiol level

  serum total thiol level in μmol/L

  Baseline (preprandial in the morning)

• Disulphide/native thiol ratio

  Disulphide/native thiol ratio X (100 )

  Baseline (preprandial in the morning)

• Disulphide/total thiol ratio

  Disulphide/total thiol ratio X (100 )

  Baseline (preprandial in the morning)

• Native thiol/total thiol ratio

  Native thiol/total thiol ratio X (100 )

  Baseline (preprandial in the morning)

• Dietary antioxidant capacity

  Dietary intake assessed using 3-day dietary records. Participants instructed to record all dietary intake for 3 consecutive days, including 2 weekdays and 1 weekend day. Average value of 3 day nutrients were recorded and analyzed using Nutrition Data Base Ebispro for Windows, Stuttgart, Germany; Turkish Version (BeBiS 8.2), for Research software.

  Baseline

Secondary Outcomes (20)

• Ischemia-modified albumin

  Baseline (preprandial in the morning)

• Dietary antioxidant intake

  Baseline

• Oxidative balance score

  Baseline

• Fasting plasma glucose

  Baseline (preprandial in the morning)

• hemoglobin A1c (HbA1c)

  Baseline (preprandial in the morning)

Study Arms (2)

Diabetic participants (case group)

Participants diagnosed with type 2 diabetes mellitus

Other: Dietary antioxidant intake

Healthy participants (control group)

Participants not diagnosed with type 2 diabetes mellitus or any other chronic diseases

Other: Dietary antioxidant intake

Interventions

Dietary antioxidant intake OTHER

Decreased intake of dietary antioxidant is associated with decreased thiol disulfide homeostasis parameters in diabetic and healthy participants.

Diabetic participants (case group); Healthy participants (control group)

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants who applied to Ankara City Hospital Endochronology Polyclinic between January and April 2021.

You may qualify if:

• Diagnosis with type 2 diabetes mellitus
• Diabetes age for a maximum of 5 years
• Body mass index (BMI)\<30 kg/m\^2
• Received and applied medical nutrition therapy and metformin therapy
• Body mass index (BMI) \<30 kg/m\^2

You may not qualify if:

• Receiving insulin therapy
• Developing diabetes-specific complications
• Smoking tobacco
• Consuming alcohol
• Having end-stage chronic renal failure
• Receiving chemotherapy and/or radiotherapy
• Being in menopause, pregnant and/or lactation period
• Using antioxidant vitamin and mineral supplements
• Smoking tobacco
• Using alcohol
• Having any chronic disease
• Having end-stage chronic renal failure
• Receiving chemotherapy and/or radiotherapy
• Being in menopausal, pregnant and/or lactation period,
• Using antioxidant vitamin and mineral supplements

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead
• Baskent University: collaborator

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fasting blood samples of each participants were retained in a biorepository to assess native thiol, total thiol, disulfide and ischemia modified albumin until the analysis as described: To prevent the reduction of 5,5'-dithiobis-(2-nitrobenzoic) acid, the unused reducing sodium borohydride was consumed and removed with formaldehyde, and after the reaction with 5,5'-dithiobis-(2-nitrobenzoic) acid, all thiol groups including the reduced and native thiol groups were determined.IMA level measurement was made within 1 hour after the venous blood samples of the individuals were taken. The samples were incubated at room temperature for 30 minutes and then centrifuged at 3500 rpm for 5 minutes. Final samples were transferred to Eppendorf tubes and stored at -80ºC until analysis. The samples were incubated at room temperature for 30 minutes and then centrifuged at 3500 rpm for 5 minutes. Final samples were transferred to Eppendorf tubes and stored at -80ºC until analysis.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 10, 2022
• First Posted: January 18, 2023
• Study Start: January 3, 2021
• Primary Completion: March 12, 2021
• Study Completion: April 20, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)