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

Type 2 Diabetes Clinical Trial

Official title:

The Effect of the Phytochemical Content and Total Antioxidant Capacity of the Diet on Serum FGF21 Levels in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05937737
• Other study ID #: GO 20/228
• Status: Completed
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: April 15, 2022

Study information

• Verified date: July 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 15, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

Locations

Country	Name	City	State
Turkey	Hacettepe University Internal Medicine Department	Ankara
Turkey	Hacettepe University Nutrition and Dietetics Department	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibroblast growth factor 21 (FGF21)	FGF21 levels in serum	12 weeks
Primary	Body weight	Body weight measurements	12 weeks
Primary	Body fat percentage	Body fat percentage measured with bioelectrical impedance analysis	12 weeks
Primary	Phytochemical index	Dietary phytochemical index	12 week
Primary	Ferric Reducing Ability of Plasma (FRAP)	Dietary antioxidant capacity measured with FRAP method	12 weeks
Primary	Oxygen Radical Absorbance Capacity (ORAC)	Dietary antioxidant capacity measured with ORAC method	12 weeks
Primary	Trolox Equivalent Antioxidant Capacity (TEAC)	Dietary antioxidant capacity measured with TEAC method	12 weeks
Primary	Total Reactive Antioxidant Potential (TRAP)	Dietary antioxidant capacity measured with TRAP method	12 weeks