Type 2 DiabetesNCT05937737
Serum FGF21 Levels and Dietary Total Antioxidant Capacity in Type 2 Diabetes
A study testing Type 2 Diabetes Diet Modification in people with Type 2 Diabetes, run by Hacettepe University at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Type 2 Diabetes Diet Modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Apr 2020to 15 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Type 1 diabetes
- Cancer
- Chronic kidney disease
- Chronic liver disease
- Other chronic inflammatory diseases
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hacettepe University Internal Medicine Department
Ankara, 06100
Hacettepe University Nutrition and Dietetics Department
Ankara, 06100
About this study
Official title: The Effect of the Phytochemical Content and Total Antioxidant Capacity of the Diet on Serum FGF21 Levels in Type 2 Diabetes
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Type 2 Diabetes Diet Modification
- Keywords
- FGF-21, type 2 diabetes, antioxidant capacity, phytochemical index
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type 2 Diabetes Diet ModificationBehavioural
A 12-week dietary intervention model was prescribed to the patients in accordance with their needs.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Experimental | 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. Receives: Behavioral: Type 2 Diabetes Diet Modification |
| Healthy Controls | No intervention | No dietary intervention was made for the control group, and necessary measurements were taken at the beginning and 12th week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibroblast growth factor 21 (FGF21)
FGF21 levels in serum
Measured: 12 weeks
Body weight
Body weight measurements
Measured: 12 weeks
Body fat percentage
Body fat percentage measured with bioelectrical impedance analysis
Measured: 12 weeks
Phytochemical index
Dietary phytochemical index
Measured: 12 week
Ferric Reducing Ability of Plasma (FRAP)
Dietary antioxidant capacity measured with FRAP method
Measured: 12 weeks
Oxygen Radical Absorbance Capacity (ORAC)
Dietary antioxidant capacity measured with ORAC method
Measured: 12 weeks
Trolox Equivalent Antioxidant Capacity (TEAC)
Dietary antioxidant capacity measured with TEAC method
Measured: 12 weeks
Total Reactive Antioxidant Potential (TRAP)
Dietary antioxidant capacity measured with TRAP method
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start20 Apr 2020
- Primary completion30 Dec 2021
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Goktas, Hacettepe University
- Investigators
- Zeynep Goktas, PhD, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937737
- Sponsor's protocol ID
- GO 20/228
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Phytochemical Content and Total Antioxidant Capacity of the Diet on Serum FGF21 Levels in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05937737
- Acronym / sponsor ID
- GO 20/228
- Conditions
- Type 2 Diabetes
- Keywords
- FGF-21, type 2 diabetes, antioxidant capacity, phytochemical index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | Experimental | Behavioral: Type 2 Diabetes Diet ModificationIndividuals 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. |
| Healthy Controls | No intervention | –No dietary intervention was made for the control group, and necessary measurements were taken at the beginning and 12th week. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- Pregnancy
- Type 1 diabetes
- Cancer
- Chronic kidney disease
- Chronic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type 2 Diabetes Diet ModificationA 12-week dietary intervention model was prescribed to the patients in accordance with their needs. | Behavioural | Type 2 Diabetes |
Primary outcome
Fibroblast growth factor 21 (FGF21)
Time frame: 12 weeks
FGF21 levels in serum
Body weight
Time frame: 12 weeks
Body weight measurements
Body fat percentage
Time frame: 12 weeks
Body fat percentage measured with bioelectrical impedance analysis
Phytochemical index
Time frame: 12 week
Dietary phytochemical index
Ferric Reducing Ability of Plasma (FRAP)
Time frame: 12 weeks
Dietary antioxidant capacity measured with FRAP method
Oxygen Radical Absorbance Capacity (ORAC)
Time frame: 12 weeks
Dietary antioxidant capacity measured with ORAC method
Trolox Equivalent Antioxidant Capacity (TEAC)
Time frame: 12 weeks
Dietary antioxidant capacity measured with TEAC method
Total Reactive Antioxidant Potential (TRAP)
Time frame: 12 weeks
Dietary antioxidant capacity measured with TRAP method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep Goktas, PhD principal investigator
Hacettepe University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type 2 Diabetes Diet Modification in people with Type 2 Diabetes, run by Hacettepe University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibroblast growth factor 21 (FGF21) (time frame: 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.