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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Type 2 Diabetes Diet Modification
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Type 2 Diabetes focused on measuring FGF-21, type 2 diabetes, antioxidant capacity, phytochemical index

Eligibility Criteria

19 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hacettepe University Internal Medicine Department
  • Hacettepe University Nutrition and Dietetics Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Type 2 Diabetes

Healthy Controls

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Fibroblast growth factor 21 (FGF21)
FGF21 levels in serum
Body weight
Body weight measurements
Body fat percentage
Body fat percentage measured with bioelectrical impedance analysis
Phytochemical index
Dietary phytochemical index
Ferric Reducing Ability of Plasma (FRAP)
Dietary antioxidant capacity measured with FRAP method
Oxygen Radical Absorbance Capacity (ORAC)
Dietary antioxidant capacity measured with ORAC method
Trolox Equivalent Antioxidant Capacity (TEAC)
Dietary antioxidant capacity measured with TEAC method
Total Reactive Antioxidant Potential (TRAP)
Dietary antioxidant capacity measured with TRAP method

Secondary Outcome Measures

Full Information

First Posted
June 21, 2023
Last Updated
July 10, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05937737
Brief Title
Serum FGF21 Levels and Dietary Total Antioxidant Capacity in Type 2 Diabetes
Official Title
The Effect of the Phytochemical Content and Total Antioxidant Capacity of the Diet on Serum FGF21 Levels in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
April 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
FGF-21, type 2 diabetes, antioxidant capacity, phytochemical index

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type 2 Diabetes
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Controls
Arm Type
No Intervention
Arm Description
No dietary intervention was made for the control group, and necessary measurements were taken at the beginning and 12th week.
Intervention Type
Behavioral
Intervention Name(s)
Type 2 Diabetes Diet Modification
Intervention Description
A 12-week dietary intervention model was prescribed to the patients in accordance with their needs.
Primary Outcome Measure Information:
Title
Fibroblast growth factor 21 (FGF21)
Description
FGF21 levels in serum
Time Frame
12 weeks
Title
Body weight
Description
Body weight measurements
Time Frame
12 weeks
Title
Body fat percentage
Description
Body fat percentage measured with bioelectrical impedance analysis
Time Frame
12 weeks
Title
Phytochemical index
Description
Dietary phytochemical index
Time Frame
12 week
Title
Ferric Reducing Ability of Plasma (FRAP)
Description
Dietary antioxidant capacity measured with FRAP method
Time Frame
12 weeks
Title
Oxygen Radical Absorbance Capacity (ORAC)
Description
Dietary antioxidant capacity measured with ORAC method
Time Frame
12 weeks
Title
Trolox Equivalent Antioxidant Capacity (TEAC)
Description
Dietary antioxidant capacity measured with TEAC method
Time Frame
12 weeks
Title
Total Reactive Antioxidant Potential (TRAP)
Description
Dietary antioxidant capacity measured with TRAP method
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep Goktas, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe University Internal Medicine Department
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Hacettepe University Nutrition and Dietetics Department
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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