Serum FGF21 Levels and Dietary Total Antioxidant Capacity in Type 2 Diabetes

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT05937737
Collaborator
(none)
76
2
2
23.8
38
1.6

Study Details

Study Description

Brief Summary

This study aimed to evaluate the phytochemicals and total antioxidant capacity in the diets of individuals with type 2 diabetes and assess their relationship with glycemic parameters, as well as certain biochemical parameters and Fibroblast growth factor 21 (FGF21), which is an inflammatory marker. The study was conducted on a total of 80 individuals, including 40 patients with overweight or obesity (Body Mass Index (BMI) > 25 kg/m²) with type 2 diabetes aged between 18 and 64, and 40 healthy controls (BMI between 18.5-35 kg/m²). The individuals were followed for 12 weeks with an appropriate diet. Biochemical parameters, anthropometric measurements, and dietary intake records were monitored at specific intervals throughout the study. The phytochemical index and total antioxidant capacity of the individuals' diets were measured, and FGF21 was examined in the serum.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Type 2 Diabetes Diet Modification
N/A

Detailed Description

Individuals were divided into two groups: type 2 diabetes and control. Individuals with type 2 diabetes were followed for 12 weeks with an appropriate diet specific to their condition, and necessary measurements were taken at the beginning, 4th week, and 12th week. No dietary intervention was made for the control group, and necessary measurements were taken at the beginning and 12th week. At the control points, biochemical parameters, serum samples, anthropometric measurements (body composition, weight, height, waist circumference, hip circumference), 24-hour dietary intake record, and 24-hour physical activity record were evaluated. In the experimental group, dietary intake was recorded at the beginning (week 0), 4th week, and 12th week. The dietary intake of the control group was examined at week 0 and week 12.

The "Phytochemical Index" method was used to calculate the total phytochemical intake from the diet. The total antioxidant capacity of the diet was calculated using data obtained from dietary intake records based on Ferric Reducing Ability of Plasma (FRAP), Oxygen Radical Absorbance Capacity (ORAC), Trolox Equivalent Antioxidant Capacity (TEAC), and Total Reactive Antioxidant Potential (TRAP) methods. Additionally, physical activity was determined using a recording method. Body compositions at all three control points will be determined using the bioelectrical impedance method, and waist and hip circumference measurements were taken using a non-stretchable tape measure. Routine biochemical parameters for the type 2 diabetic group (fasting blood glucose, serum lipids, HbA1c) were obtained from the records. Serum samples collected after a 10-12 hour fasting period at the beginning and 12th week were analyzed for Fibroblast growth factor 21 (FGF21) using suitable kits.

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
The Effect of the Phytochemical Content and Total Antioxidant Capacity of the Diet on Serum FGF21 Levels in Type 2 Diabetes
Actual Study Start Date :
Apr 20, 2020
Actual Primary Completion Date :
Dec 30, 2021
Actual Study Completion Date :
Apr 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Type 2 Diabetes

Individuals with type 2 diabetes were followed for 12 weeks with an appropriate diet specific to their type 2 diabetes condition, and necessary measurements were taken at the beginning, 4th week, and 12th week.

Behavioral: Type 2 Diabetes Diet Modification
A 12-week dietary intervention model was prescribed to the patients in accordance with their needs.

No Intervention: Healthy Controls

No dietary intervention was made for the control group, and necessary measurements were taken at the beginning and 12th week.

Outcome Measures

Primary Outcome Measures

  1. Fibroblast growth factor 21 (FGF21) [12 weeks]

    FGF21 levels in serum

  2. Body weight [12 weeks]

    Body weight measurements

  3. Body fat percentage [12 weeks]

    Body fat percentage measured with bioelectrical impedance analysis

  4. Phytochemical index [12 week]

    Dietary phytochemical index

  5. Ferric Reducing Ability of Plasma (FRAP) [12 weeks]

    Dietary antioxidant capacity measured with FRAP method

  6. Oxygen Radical Absorbance Capacity (ORAC) [12 weeks]

    Dietary antioxidant capacity measured with ORAC method

  7. Trolox Equivalent Antioxidant Capacity (TEAC) [12 weeks]

    Dietary antioxidant capacity measured with TEAC method

  8. Total Reactive Antioxidant Potential (TRAP) [12 weeks]

    Dietary antioxidant capacity measured with TRAP method

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • For intervention group: type 2 diabetes diagnosis

  • For control group: healthy individuals

  • Aged between 19 and 64

  • With a body mass index over 25 kg/m²

Exclusion Criteria:
  • Pregnancy

  • Type 1 diabetes

  • Cancer

  • Chronic kidney disease

  • Chronic liver disease

  • Other chronic inflammatory diseases

  • Individuals with HbA1c levels above 9%

  • Individuals using short or medium-acting or mixed (medium+short) insulin

  • Individuals with any condition that hinders physical activity

  • Individuals following any weight loss diet

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hacettepe University Internal Medicine Department Ankara Turkey 06100
2 Hacettepe University Nutrition and Dietetics Department Ankara Turkey 06100

Sponsors and Collaborators

  • Hacettepe University

Investigators

  • Principal Investigator: Zeynep Goktas, PhD, Hacettepe University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zeynep Goktas, Principal Investigator, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05937737
Other Study ID Numbers:
  • GO 20/228
First Posted:
Jul 10, 2023
Last Update Posted:
Jul 11, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zeynep Goktas, Principal Investigator, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 11, 2023