Metabolic SyndromeNCT06881706
Link Between Biochemical, Anthropometric Variables and CD36 in Metabolic Syndrome After a Low-calorie Diet
A study testing medical nutrition therapy in people with Metabolic Syndrome and Weight Loss, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the effects of a weight loss diet on biochemical, anthropometric variables, and cluster of differentiation 36 (CD36) levels in 65 patients newly diagnosed with metabolic syndrome (MetS). Participants followed an 8-week medical nutrition therapy (MNT) designed to achieve at least 5% weight loss. Read more about this study
- Who is it for?
- Ages 19 to 64 years
- Conditions the study is for
- Metabolic Syndrome, Weight Loss
- What is being tested?
- medical nutrition therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 30 Mar 2020
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Being between the ages of 19-64
- Being diagnosed with MetS by a physician according to the International Diabetes Federation (IDF)-2005 metabolic syndrome diagnostic criteria
- Being a volunteer to participate in the study
Who cannot join
- Being pregnant and breastfeeding
- Smoking and drinking alcohol
- Having any chronic disease other than metabolic syndrome
- Taking regular medication
- Taking regular nutritional supplements
- Having a change in weight within the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Biochemical and Anthropometric Variables and CD36 Levels in Metabolic Syndrome Patients After Low Calorie Diet
This study evaluated the effects of a weight loss diet on biochemical, anthropometric variables, and cluster of differentiation 36 (CD36) levels in 65 patients newly diagnosed with metabolic syndrome (MetS). Participants followed an 8-week medical nutrition therapy (MNT) designed to achieve at least 5% weight loss. Significant changes were observed in some biochemical parameters and blood pressure among those who adhered to the diet. CD36 levels showed correlations with various metabolic and body composition parameters.
Read the detailed description
This research aimed to assess the impact of a weight loss diet on biochemical and anthropometric variables, as well as CD36 levels, in 80 patients newly diagnosed with metabolic syndrome (MetS) who began a weight loss program. The study was completed all of whom were diagnosed with MetS and had applied to the Internal Medicine Outpatient Clinic at Ordu University Training and Research Hospital. At the start of the study, participants were provided with medical nutrition therapy (MNT) tailored to their energy and nutritional needs, as well as their lifestyle, with the goal of achieving at least a 5% weight loss within 8 weeks. Patients were monitored regularly throughout the process.
Before initiating MNT, participants' general characteristics and dietary habits were collected through face-to-face interviews. Additionally, 24-hour dietary recalls and anthropometric measurements were taken both before and at the end of the 8th week. Biochemical data were retrieved from patient records, blood pressure was measured by a physician, and fasting blood samples were collected for CD36 analysis, which were then stored at -80°C until further examination.
By the end of the study, some individuals adhered strictly to the MNT. Statistical differences were observed in some biochemical parameters and blood pressure between those who complied with MNT and those who did not. Correlations were observed between CD36 levels and some variables.
- Conditions
- Metabolic Syndrome, Weight Loss
- Being tested
- medical nutrition therapy
- Keywords
- metabolic syndrome, weight loss, cd36, fatty acids, fatty acid receptor
- Medical subject headings
- Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical nutrition therapyOther
Also called hypocaloric diet intervention, weight loss intervention
Medical nutrition treatment was planned for all participants with metabolic syndrome. A diet plan was created considering age, gender, blood findings and nutritional habits. Individuals with MetS were given a weight loss diet planned at the basal energy level calculated with the Harris-Benedict equation and applied for 8 weeks. Individuals who applied the weight loss diet were targeted to lose at least 5% of their initial weight at the end of 8 weeks. Individuals who strictly followed the given medical nutrition treatment and achieved the targeted weight loss formed the intervention group, and individuals who did not follow the medical nutrition treatment formed the control group. At the end of the 8 weeks, all parameters, blood pressure and anthropometric measurements of all individuals who participated in the study and retrospective 24-hour food consumption records were recorded again and the study was concluded.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | At the beginning of the study, all participants were given a hypocaloric diet to induce weight loss. Individuals who followed the diet and lost at least 5% of their starting weight constituted this group. Receives: Other: medical nutrition therapy |
| Control Group | No intervention | At the beginning of the study, all participants were given a hypocaloric diet to induce weight loss. Individuals who did not follow the diet and did not lose at least 5% of their starting weight constituted this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the intervention group
A decrease in body weight, improvement in biochemical findings and a decrease in serum CD36 levels are expected in individuals who follow the given diet.
Measured: Week 0 - Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start1 Jun 2019
- Primary completion1 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 groups in the study. Both groups consist of individuals with newly diagnosed metabolic syndrome. The first group (intervention group) is the group that applied a weight loss diet and achieved weight loss. The second group (control group) is the group that did not apply a diet and did not achieve weight loss.
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu MATARACI DEĞİRMENCİ, Ordu University
- Investigators
- Mehmet FISUNOGLU, Assoc. Prof., Study director, Hacettepe UniversityOzlem Ozdemir, Assist. Prof, Study chair, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881706
- Sponsor's protocol ID
- Metabolic syndrome and CD36
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not want to share this before publishing the research as a research article.
Publications
Khaleel AA, Al-Barzinji RMGT. Soluble CD36 Concentration in Diabetic Hypertensive Patients with Coronary Atherosclerosis. Cell Mol Biol (Noisy-le-grand). 2022 May 22;68(1):109-116. doi: 10.14715/cmb/2022.68.1.14.
PubMed 35809322Rac ME, Safranow K, Garanty-Bogacka B, Dziedziejko V, Kurzawski G, Goschorska M, Kuligowska A, Pauli N, Chlubek D. CD36 gene polymorphism and plasma sCD36 as the risk factor in higher cholesterolemia. Arch Pediatr. 2018 Apr;25(3):177-181. doi: 10.1016/j.arcped.2018.01.008. Epub 2018 Mar 23.
PubMed 29576254Blomquist C, Chorell E, Ryberg M, Mellberg C, Worrsjo E, Makoveichuk E, Larsson C, Lindahl B, Olivecrona G, Olsson T. Decreased lipogenesis-promoting factors in adipose tissue in postmenopausal women with overweight on a Paleolithic-type diet. Eur J Nutr. 2018 Dec;57(8):2877-2886. doi: 10.1007/s00394-017-1558-0. Epub 2017 Oct 26.
PubMed 29075849do Amaral CL, Milagro FI, Curi R, Martinez JA. DNA methylation pattern in overweight women under an energy-restricted diet supplemented with fish oil. Biomed Res Int. 2014;2014:675021. doi: 10.1155/2014/675021. Epub 2014 Jan 22.
PubMed 24579084Mora-Rodriguez R, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M. Weight loss but not gains in cardiorespiratory fitness after exercise-training predicts improved health risk factors in metabolic syndrome. Nutr Metab Cardiovasc Dis. 2018 Dec;28(12):1267-1274. doi: 10.1016/j.numecd.2018.08.004. Epub 2018 Aug 23.
PubMed 30459053Alkhatatbeh MJ, Ayoub NM, Mhaidat NM, Saadeh NA, Lincz LF. Soluble cluster of differentiation 36 concentrations are not associated with cardiovascular risk factors in middle-aged subjects. Biomed Rep. 2016 May;4(5):642-648. doi: 10.3892/br.2016.622. Epub 2016 Mar 3.
PubMed 27123261Yanai H, Chiba H, Morimoto M, Jamieson GA, Matsuno K. Type I CD36 deficiency in humans is not associated with insulin resistance syndrome. Thromb Haemost. 2000 May;83(5):786. No abstract available.
PubMed 10823279Furuhashi M, Ura N, Nakata T, Shimamoto K. Insulin sensitivity and lipid metabolism in human CD36 deficiency. Diabetes Care. 2003 Feb;26(2):471-4. doi: 10.2337/diacare.26.2.471.
PubMed 12547883Lopez-Carmona MD, Plaza-Seron MC, Vargas-Candela A, Tinahones FJ, Gomez-Huelgas R, Bernal-Lopez MR. CD36 overexpression: a possible etiopathogenic mechanism of atherosclerosis in patients with prediabetes and diabetes. Diabetol Metab Syndr. 2017 Jul 18;9:55. doi: 10.1186/s13098-017-0253-x. eCollection 2017.
PubMed 28729885Griffin E, Re A, Hamel N, Fu C, Bush H, McCaffrey T, Asch AS. A link between diabetes and atherosclerosis: Glucose regulates expression of CD36 at the level of translation. Nat Med. 2001 Jul;7(7):840-6. doi: 10.1038/89969.
PubMed 11433350Marechal L, Laviolette M, Rodrigue-Way A, Sow B, Brochu M, Caron V, Tremblay A. The CD36-PPARgamma Pathway in Metabolic Disorders. Int J Mol Sci. 2018 May 21;19(5):1529. doi: 10.3390/ijms19051529.
PubMed 29883404Pardina E, Ferrer R, Rossell J, Ricart-Jane D, Mendez-Lara KA, Baena-Fustegueras JA, Lecube A, Julve J, Peinado-Onsurbe J. Hepatic CD36 downregulation parallels steatosis improvement in morbidly obese undergoing bariatric surgery. Int J Obes (Lond). 2017 Sep;41(9):1388-1393. doi: 10.1038/ijo.2017.115. Epub 2017 May 10.
PubMed 28555086Botha J, Nielsen MH, Christensen MH, Vestergaard H, Handberg A. Bariatric surgery reduces CD36-bearing microvesicles of endothelial and monocyte origin. Nutr Metab (Lond). 2018 Oct 23;15:76. doi: 10.1186/s12986-018-0309-4. eCollection 2018.
PubMed 30386406Knosgaard L, Kazankov K, Birkebaek NH, Holland-Fischer P, Lange A, Solvig J, Horlyck A, Kristensen K, Rittig S, Vilstrup H, Gronbaek H, Handberg A. Reduced sCD36 following weight loss corresponds to improved insulin sensitivity, dyslipidemia and liver fat in obese children. Eur J Clin Nutr. 2016 Sep;70(9):1073-7. doi: 10.1038/ejcn.2016.88. Epub 2016 Jun 8.
PubMed 27273071
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Biochemical and Anthropometric Variables and CD36 Levels in Metabolic Syndrome Patients After Low Calorie Diet
- ClinicalTrials.gov ID
- NCT06881706
- Acronym / sponsor ID
- Metabolic syndrome and CD36
- Conditions
- Metabolic Syndrome, Weight Loss
- Keywords
- metabolic syndrome, weight loss, cd36, fatty acids, fatty acid receptor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 18 Mar 2025 (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 evaluated the effects of a weight loss diet on biochemical, anthropometric variables, and cluster of differentiation 36 (CD36) levels in 65 patients newly diagnosed with metabolic syndrome (MetS). Participants followed an 8-week medical nutrition therapy (MNT) designed to achieve at least 5% weight loss. Significant changes were observed in some biochemical parameters and blood pressure among those who adhered to the diet. CD36 levels showed correlations with various metabolic and body composition parameters.
Detailed description
This research aimed to assess the impact of a weight loss diet on biochemical and anthropometric variables, as well as CD36 levels, in 80 patients newly diagnosed with metabolic syndrome (MetS) who began a weight loss program. The study was completed all of whom were diagnosed with MetS and had applied to the Internal Medicine Outpatient Clinic at Ordu University Training and Research Hospital. At the start of the study, participants were provided with medical nutrition therapy (MNT) tailored to their energy and nutritional needs, as well as their lifestyle, with the goal of achieving at least a 5% weight loss within 8 weeks. Patients were monitored regularly throughout the process.
Before initiating MNT, participants' general characteristics and dietary habits were collected through face-to-face interviews. Additionally, 24-hour dietary recalls and anthropometric measurements were taken both before and at the end of the 8th week. Biochemical data were retrieved from patient records, blood pressure was measured by a physician, and fasting blood samples were collected for CD36 analysis, which were then stored at -80°C until further examination.
By the end of the study, some individuals adhered strictly to the MNT. Statistical differences were observed in some biochemical parameters and blood pressure between those who complied with MNT and those who did not. Correlations were observed between CD36 levels and some variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are 2 groups in the study. Both groups consist of individuals with newly diagnosed metabolic syndrome. The first group (intervention group) is the group that applied a weight loss diet and achieved weight loss. The second group (control group) is the group that did not apply a diet and did not achieve weight loss.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: medical nutrition therapyAt the beginning of the study, all participants were given a hypocaloric diet to induce weight loss. Individuals who followed the diet and lost at least 5% of their starting weight constituted this group. |
| Control Group | No intervention | –At the beginning of the study, all participants were given a hypocaloric diet to induce weight loss. Individuals who did not follow the diet and did not lose at least 5% of their starting weight constituted this group. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Being between the ages of 19-64
- Being diagnosed with MetS by a physician according to the International Diabetes Federation (IDF)-2005 metabolic syndrome diagnostic criteria
- Being a volunteer to participate in the study
Key exclusion criteria (6 listed)
- Being pregnant and breastfeeding
- Smoking and drinking alcohol
- Having any chronic disease other than metabolic syndrome
- Taking regular medication
- Taking regular nutritional supplements
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 |
|---|---|---|
| medical nutrition therapyAlso: hypocaloric diet intervention, weight loss interventionMedical nutrition treatment was planned for all participants with metabolic syndrome. A diet plan was created considering age, gender, blood findings and nutritional habits. Individuals with MetS were given a weight loss diet planned at the basal energy level calculated with the Harris-Benedict equation and applied for 8 weeks. Individuals who applied the weight loss diet were targeted to lose at least 5% of their initial weight at the end of 8 weeks. Individuals who strictly followed the given medical nutrition treatment and achieved the targeted weight loss formed the intervention group, and individuals who did not follow the medical nutrition treatment formed the control group. At the end of the 8 weeks, all parameters, blood pressure and anthropometric measurements of all individuals who participated in the study and retrospective 24-hour food consumption records were recorded again and the study was concluded. | Other | Intervention Group |
Primary outcome
Change in the intervention group
Time frame: Week 0 - Week 8
A decrease in body weight, improvement in biochemical findings and a decrease in serum CD36 levels are expected in individuals who follow the given diet.
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 18 Mar 2025.
- Results publication: PubMed 35809322Khaleel AA, Al-Barzinji RMGT. Soluble CD36 Concentration in Diabetic Hypertensive Patients with Coronary Atherosclerosis. Cell Mol Biol (Noisy-le-grand). 2022 May 22;68(1):109-116. doi: 10.14715/cmb/2022.68.1.14.
- Results publication: PubMed 29576254Rac ME, Safranow K, Garanty-Bogacka B, Dziedziejko V, Kurzawski G, Goschorska M, Kuligowska A, Pauli N, Chlubek D. CD36 gene polymorphism and plasma sCD36 as the risk factor in higher cholesterolemia. Arch Pediatr. 2018 Apr;25(3):177-181. doi: 10.1016/j.arcped.2018.01.008. Epub 2018 Mar 23.
- Results publication: PubMed 29075849Blomquist C, Chorell E, Ryberg M, Mellberg C, Worrsjo E, Makoveichuk E, Larsson C, Lindahl B, Olivecrona G, Olsson T. Decreased lipogenesis-promoting factors in adipose tissue in postmenopausal women with overweight on a Paleolithic-type diet. Eur J Nutr. 2018 Dec;57(8):2877-2886. doi: 10.1007/s00394-017-1558-0. Epub 2017 Oct 26.
- Results publication: PubMed 24579084do Amaral CL, Milagro FI, Curi R, Martinez JA. DNA methylation pattern in overweight women under an energy-restricted diet supplemented with fish oil. Biomed Res Int. 2014;2014:675021. doi: 10.1155/2014/675021. Epub 2014 Jan 22.
- Results publication: PubMed 30459053Mora-Rodriguez R, Ortega JF, Morales-Palomo F, Ramirez-Jimenez M. Weight loss but not gains in cardiorespiratory fitness after exercise-training predicts improved health risk factors in metabolic syndrome. Nutr Metab Cardiovasc Dis. 2018 Dec;28(12):1267-1274. doi: 10.1016/j.numecd.2018.08.004. Epub 2018 Aug 23.
- Results publication: PubMed 27123261Alkhatatbeh MJ, Ayoub NM, Mhaidat NM, Saadeh NA, Lincz LF. Soluble cluster of differentiation 36 concentrations are not associated with cardiovascular risk factors in middle-aged subjects. Biomed Rep. 2016 May;4(5):642-648. doi: 10.3892/br.2016.622. Epub 2016 Mar 3.
- Results publication: PubMed 10823279Yanai H, Chiba H, Morimoto M, Jamieson GA, Matsuno K. Type I CD36 deficiency in humans is not associated with insulin resistance syndrome. Thromb Haemost. 2000 May;83(5):786. No abstract available.
- Results publication: PubMed 12547883Furuhashi M, Ura N, Nakata T, Shimamoto K. Insulin sensitivity and lipid metabolism in human CD36 deficiency. Diabetes Care. 2003 Feb;26(2):471-4. doi: 10.2337/diacare.26.2.471.
- Results publication: PubMed 28729885Lopez-Carmona MD, Plaza-Seron MC, Vargas-Candela A, Tinahones FJ, Gomez-Huelgas R, Bernal-Lopez MR. CD36 overexpression: a possible etiopathogenic mechanism of atherosclerosis in patients with prediabetes and diabetes. Diabetol Metab Syndr. 2017 Jul 18;9:55. doi: 10.1186/s13098-017-0253-x. eCollection 2017.
- Results publication: PubMed 11433350Griffin E, Re A, Hamel N, Fu C, Bush H, McCaffrey T, Asch AS. A link between diabetes and atherosclerosis: Glucose regulates expression of CD36 at the level of translation. Nat Med. 2001 Jul;7(7):840-6. doi: 10.1038/89969.
- Results publication: PubMed 29883404Marechal L, Laviolette M, Rodrigue-Way A, Sow B, Brochu M, Caron V, Tremblay A. The CD36-PPARgamma Pathway in Metabolic Disorders. Int J Mol Sci. 2018 May 21;19(5):1529. doi: 10.3390/ijms19051529.
- Results publication: PubMed 28555086Pardina E, Ferrer R, Rossell J, Ricart-Jane D, Mendez-Lara KA, Baena-Fustegueras JA, Lecube A, Julve J, Peinado-Onsurbe J. Hepatic CD36 downregulation parallels steatosis improvement in morbidly obese undergoing bariatric surgery. Int J Obes (Lond). 2017 Sep;41(9):1388-1393. doi: 10.1038/ijo.2017.115. Epub 2017 May 10.
- Individual participant dataSharing planned: No. I do not want to share this before publishing the research as a research article.
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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.
Mehmet FISUNOGLU, Assoc. Prof. study director
Hacettepe University
Ozlem Ozdemir, Assist. Prof study chair
Ordu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medical nutrition therapy in people with Metabolic Syndrome and Weight Loss, run by Ordu University at 1 site 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 3 inclusion and 6 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in the intervention group (time frame: Week 0 - Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06881706, which also lists 14 linked publications.
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 18 Mar 2025.