Type 2 Diabetes MellitusObesityNCT07870122
Sleep Quality, Adiposity and Diet Quality
An observational study of Type 2 Diabetes Mellitus and Health Adult Subjects, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of sleep quality on cardiovascular disease risk and food and nutrient intakes. Within the scope of this study, several parameters associated with cardiovascular disease risk will be assessed, including waist circumference, hip circumference, waist-to-hip ratio… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Health Adult Subjects
- How many people
- 209 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2026to 15 Nov 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with type 2 diabetes mellitus who present to the Internal Medicine Outpatient Clinic of İzmir City Hospital will be included in this study. Healthy individuals without any chronic diseases will be included in this study.
Who may be able to join
- -
- Type 2 diabetes mellitus will be diagnosed based on the presence of any of the following criteria:
- Fasting plasma glucose ≥126 mg/dL (7.0 mmol/L)
- Hemoglobin A1c ≥6.5% (48 mmol/mol)
- Random plasma glucose ≥200 mg/dL (11.1 mmol/L) in the presence of classic symptoms of hyperglycemia, such as excessive thirst, frequent urination, and unexplained weight loss
Who cannot join
- Pregnant or lactating women,
- Individuals diagnosed with known nephrolithiasis, glomerulonephritis or lupus nephritis, primary nephrotic syndrome, or other diagnosed kidney diseases,
- Individuals with parathyroid disease,
- Individuals with autoimmune diseases,
- Individuals with an acute infection,
- Individuals with chronic obstructive pulmonary disease,
Show all 18Show fewer
- Individuals with cardiovascular or cerebrovascular disease,
- Individuals with type 1 diabetes mellitus or forms of diabetes other than type 2 diabetes mellitus,
- Individuals with cancer,
- Individuals using any nutrient supplements or other dietary supplements,
- Individuals using sleep medications and/or experiencing severe sleep problems,
- Individuals using medications that may affect metabolism or sleep quality, such as corticosteroids, statins, or antipsychotics,
- Individuals who are unwilling to participate in the study.
- Individuals with any metabolic health disorder,
- Individuals who use sleep medications and/or have severe sleep problems,
- Individuals who use any nutrient supplements or other dietary supplements,
- Pregnant or breastfeeding women,
- Individuals who are unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
İzmir City Hospital
Izmir, 35310
Sibel DEMİRAL SEZER, PhD, +90 232 955 05 00, drdemiralsibel@yahoo.com
About this study
Official title: Association of Sleep Quality With Visceral Adiposity, Cardiovascular Disease Risk, and Diet Quality in Individuals With Type 2 Diabetes
The aim of this study is to evaluate the effects of sleep quality on cardiovascular disease risk and food and nutrient intakes. Within the scope of this study, several parameters associated with cardiovascular disease risk will be assessed, including waist circumference, hip circumference, waist-to-hip ratio, waist-to-height ratio, triceps skinfold thickness, mid-upper arm circumference, and serum levels of glucose, HbA1c, insulin, LDL cholesterol, HDL cholesterol, total cholesterol, homocysteine, and lipoprotein(a). Cardiovascular disease risk will be evaluated using the Framingham Risk Score, SCORE2, and A Body Shape Index (ABSI).
To assess visceral adiposity, a formula incorporating waist circumference and serum triglyceride and HDL cholesterol levels will be used. In addition, participants' body fat and muscle percentages will be determined. Carbohydrate, fat, protein, vitamin, mineral, and fluid intakes will also be compared between individuals with poor and good sleep quality, and the effects of sleep quality on nutrient intake will be evaluated.
Read more
Previous studies investigating the effects of sleep quality on diabetes or cardiovascular diseases have predominantly been conducted among middle-aged adults aged 50 years and older, a population with a higher prevalence of dysglycemia, dyslipidemia, and hypertension. In the present project, all eligible adults aged 18 years and older will be evaluated. Furthermore, to our knowledge, no previous study has comprehensively evaluated the effects of sleep quality on cardiovascular disease risk together with nutrient intakes among individuals with type 2 diabetes.
This study is expected to contribute to the literature by evaluating the effects of sleep quality on cardiovascular disease risk among individuals with type 2 diabetes. In addition, the extent to which sleep quality is associated with dietary habits will be examined at the level of nutrient intake. The findings of this study may provide a basis for educational interventions aimed at emphasizing the importance of sleep quality and improving sleep quality, as well as for future public health initiatives. Improving sleep quality may also contribute to strategies aimed at preventing the development of type 2 diabetes and improving the management of its complications.
Read the detailed description
The aim of this study is to evaluate the effects of sleep quality on cardiovascular disease risk and food and nutrient intakes. Within the scope of this study, several parameters associated with cardiovascular disease risk will be assessed, including waist circumference, hip circumference, waist-to-hip ratio, waist-to-height ratio, triceps skinfold thickness, mid-upper arm circumference, and serum levels of glucose, HbA1c, insulin, LDL cholesterol, HDL cholesterol, total cholesterol, homocysteine, and lipoprotein(a). Cardiovascular disease risk will be evaluated using the Framingham Risk Score, SCORE2, and A Body Shape Index (ABSI).
To assess visceral adiposity, a formula incorporating waist circumference and serum triglyceride and HDL cholesterol levels will be used. In addition, participants' body fat and muscle percentages will be determined. Carbohydrate, fat, protein, vitamin, mineral, and fluid intakes will also be compared between individuals with poor and good sleep quality, and the effects of sleep quality on nutrient intake will be evaluated.
- Conditions
- Type 2 Diabetes Mellitus, Health Adult Subjects
- Keywords
- Type 2 Diabetes Mellitus, Sleep quality, Diet Quality, Visseral Adiposity
- Medical subject headings
- Diabetes Mellitus, Type 2, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Type 2 Diabetes | Individuals with type 2 diabetes mellitus who present to the Internal Medicine Outpatient Clinic of Izmir City Hospital will be included in this study. | |
| Healthy Individuals | Healthy individuals without any chronic diseases will be included in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lipoprotein a levels
Participants' serum lipoprotein(a) [Lp(a)] levels will be analyzed using an ELISA kit.
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (29)
Body Weight
Body weight will be measured in the fasting state using a portable bathroom scale with a precision of 1 kg, while participants are wearing light clothing and no shoes, in accordance with standard measurement procedures.
Measured: From enrollment to the end of treatment at 2 years
Height
Height will be measured without shoes, with the feet together and the heels, back, shoulders, and back of the head touching the wall. Participants will stand upright with the head positioned in the Frankfurt plane (with the lower margin of the orbit and the upper margin of the external auditory meatus aligned horizontally and parallel to the floor). The distance from the highest point of the head to the floor will be measured in centimeters (cm) using a non-stretchable measuring tape.
Measured: From enrollment to the end of treatment at 2 years
Body Mass Index
Body mass index will be calculated in kg/m² using the formula: body weight/ height².
Measured: From enrollment to the end of treatment at 2 years
Waist Circumference
Waist circumference will be measured with the participant standing with the arms at the sides and the feet together. The midpoint between the lowest rib and the iliac crest will be identified at the waist level, and the measurement will be taken using a non-stretchable measuring tape positioned parallel to the floor.
Measured: From enrollment to the end of treatment at 2 years
Hip Circumference
Hip circumference will be measured at the widest point, with the researcher standing beside the participant, using a non-stretchable measuring tape positioned parallel to the floor.
Measured: From enrollment to the end of treatment at 2 years
Waist to Hip Ratio
The waist-to-hip ratio will be calculated by dividing waist circumference by hip circumference
Measured: From enrollment to the end of treatment at 2 years
Waist to Height Ratio
The waist-to-height ratio (WHtR) will be calculated by dividing waist circumference by height.
Measured: From enrollment to the end of treatment at 2 years
Mid-upper arm circumference
For the measurement of mid-upper arm circumference, participants will stand with the arm flexed at the elbow at a 90° angle. The midpoint between the acromion process of the shoulder and the olecranon process of the elbow will be identified and marked by the researcher. The arm will then be allowed to hang freely, and mid-upper arm circumference will be measured at the marked midpoint using a non-stretchable measuring tape.
Measured: From enrollment to the end of treatment at 2 years
Triceps skinfold thickness
Participants' triceps skinfold thickness will be measured.
Measured: From enrollment to the end of treatment at 2 years
Fat-free mass
Fat-free mass (FFM) will be measured using bioelectrical impedance analysis
Measured: From enrollment to the end of treatment at 2 years
Fat-free mass ratio
Fat-free mass ratio will be measured using bioelectrical impedance analysis
Measured: From enrollment to the end of treatment at 2 years
Body Fat Mass
Body fat mass will be measured using bioelectrical impedance analysis
Measured: From enrollment to the end of treatment at 2 years
Body Fat Ratio
Body fat ratio will be measured using bioelectrical impedance analysis
Measured: From enrollment to the end of treatment at 2 years
Total body water
Total body water will be measured using bioelectrical impedance analysis
Measured: From enrollment to the end of treatment at 2 years
Total body water percentage
Total body water percentage will be measured using bioelectrical impedance analysis
Measured: From enrollment to the end of treatment at 2 years
Physical activity level
The International Physical Activity Questionnaire-Short Form will be used to assess participants' physical activity levels
Measured: From enrollment to the end of treatment at 2 years
Glucose
Participants' blood glucose levels will be assessed.
Measured: From enrollment to the end of treatment at 2 years
HbA1c
Participants' blood HbA1c levels will be assessed.
Measured: From enrollment to the end of treatment at 2 years
Triglyceride
Participants' blood triglyceride levels will be assessed.
Measured: From enrollment to the end of treatment at 2 years
Total cholesterol
Participants' blood total cholesterol levels will be assessed
Measured: From enrollment to the end of treatment at 2 years
Low Density Lipoprotein
Participants' blood low density lipoprotein levels will be assessed
Measured: From enrollment to the end of treatment at 2 years
High Density Lipoprotein
Participants' blood high density lipoprotein levels will be assessed
Measured: From enrollment to the end of treatment at 2 years
Homocysteine
Serum homocysteine levels will be determined using ELISA kits.
Measured: From enrollment to the end of treatment at 8 weeks
Visseral Obesity
Participants' visceral obesity levels will be assessed using the Visceral Adiposity Index
Measured: From enrollment to the end of treatment at 2 years
Insulin Resistance
Participants' insulin resistance will be assessed using the triglyceride-glucose index.
Measured: From enrollment to the end of treatment at 2 years
A Body Shape Index
A Body Shape Index was developed in 2012 and is calculated based on waist circumference (in meters), body weight (in kilograms), and height (in meters). It is defined using the following formula: waist circumference / (body mass index^(2/3) × height^(1/2)).
Measured: From enrollment to the end of treatment at 2 years
Framingham Risk Score
Cardiovascular disease risk will be assessed using the Framingham Risk Score.
Measured: From enrollment to the end of treatment at 2 years
Systematic Coronary Risk Evaluation
This system estimates an individual's 10-year risk of death from coronary heart disease and stroke as a percentage and categorizes the risk as low, moderate, high, or very high.
Measured: From enrollment to the end of treatment at 2 years
Diet Quality
Diet quality will be assessed using the Healthy Eating Index
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Nov 2028 (estimated)
- Study completion15 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 209 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerim Kaan Göküstün, Izmir Democracy University
- Investigators
- Sibel D SEZER, PhD, Study chair, Izmir City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870122
- Sponsor's protocol ID
- Type 2 Diabetes
- Other IDs
- 2026/427
- Acronym
- Obesity
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to participant confidentiality and data privacy considerations.
Publications
Clarke R, Peden JF, Hopewell JC, Kyriakou T, Goel A, Heath SC, Parish S, Barlera S, Franzosi MG, Rust S, Bennett D, Silveira A, Malarstig A, Green FR, Lathrop M, Gigante B, Leander K, de Faire U, Seedorf U, Hamsten A, Collins R, Watkins H, Farrall M; PROCARDIS Consortium. Genetic variants associated with Lp(a) lipoprotein level and coronary disease. N Engl J Med. 2009 Dec 24;361(26):2518-28. doi: 10.1056/NEJMoa0902604.
PubMed 20032323Tsimikas S. A Test in Context: Lipoprotein(a): Diagnosis, Prognosis, Controversies, and Emerging Therapies. J Am Coll Cardiol. 2017 Feb 14;69(6):692-711. doi: 10.1016/j.jacc.2016.11.042.
PubMed 28183512Caldeira-Araujo H, Ramos R, Florindo C, Rivera I, Castro R, Tavares de Almeida I. Homocysteine Metabolism in Children and Adolescents: Influence of Age on Plasma Biomarkers and Correspondent Genotype Interactions. Nutrients. 2019 Mar 16;11(3):646. doi: 10.3390/nu11030646.
PubMed 30884849
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Sleep Quality With Visceral Adiposity, Cardiovascular Disease Risk, and Diet Quality in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07870122
- Acronym / sponsor ID
- Obesity / Type 2 Diabetes
- Conditions
- Type 2 Diabetes Mellitus, Health Adult Subjects
- Keywords
- Type 2 Diabetes Mellitus, Sleep quality, Diet Quality, Visseral Adiposity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Nov 2028 (estimated)
- Study completion
- 15 Nov 2028 (estimated)
- First posted
- 13 Oct 2026 (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.
The aim of this study is to evaluate the effects of sleep quality on cardiovascular disease risk and food and nutrient intakes. Within the scope of this study, several parameters associated with cardiovascular disease risk will be assessed, including waist circumference, hip circumference, waist-to-hip ratio, waist-to-height ratio, triceps skinfold thickness, mid-upper arm circumference, and serum levels of glucose, HbA1c, insulin, LDL cholesterol, HDL cholesterol, total cholesterol, homocysteine, and lipoprotein(a). Cardiovascular disease risk will be evaluated using the Framingham Risk Score, SCORE2, and A Body Shape Index (ABSI).
To assess visceral adiposity, a formula incorporating waist circumference and serum triglyceride and HDL cholesterol levels will be used. In addition, participants' body fat and muscle percentages will be determined. Carbohydrate, fat, protein, vitamin, mineral, and fluid intakes will also be compared between individuals with poor and good sleep quality, and the effects of sleep quality on nutrient intake will be evaluated.
Previous studies investigating the effects of sleep quality on diabetes or cardiovascular diseases have predominantly been conducted among middle-aged adults aged 50 years and older, a population with a higher prevalence of dysglycemia, dyslipidemia, and hypertension. In the present project, all eligible adults aged 18 years and older will be evaluated. Furthermore, to our knowledge, no previous study has comprehensively evaluated the effects of sleep quality on cardiovascular disease risk together with nutrient intakes among individuals with type 2 diabetes.
This study is expected to contribute to the literature by evaluating the effects of sleep quality on cardiovascular disease risk among individuals with type 2 diabetes. In addition, the extent to which sleep quality is associated with dietary habits will be examined at the level of nutrient intake. The findings of this study may provide a basis for educational interventions aimed at emphasizing the importance of sleep quality and improving sleep quality, as well as for future public health initiatives. Improving sleep quality may also contribute to strategies aimed at preventing the development of type 2 diabetes and improving the management of its complications.
Detailed description
The aim of this study is to evaluate the effects of sleep quality on cardiovascular disease risk and food and nutrient intakes. Within the scope of this study, several parameters associated with cardiovascular disease risk will be assessed, including waist circumference, hip circumference, waist-to-hip ratio, waist-to-height ratio, triceps skinfold thickness, mid-upper arm circumference, and serum levels of glucose, HbA1c, insulin, LDL cholesterol, HDL cholesterol, total cholesterol, homocysteine, and lipoprotein(a). Cardiovascular disease risk will be evaluated using the Framingham Risk Score, SCORE2, and A Body Shape Index (ABSI).
To assess visceral adiposity, a formula incorporating waist circumference and serum triglyceride and HDL cholesterol levels will be used. In addition, participants' body fat and muscle percentages will be determined. Carbohydrate, fat, protein, vitamin, mineral, and fluid intakes will also be compared between individuals with poor and good sleep quality, and the effects of sleep quality on nutrient intake will be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Type 2 Diabetes | – | –Individuals with type 2 diabetes mellitus who present to the Internal Medicine Outpatient Clinic of Izmir City Hospital will be included in this study. |
| Healthy Individuals | – | –Healthy individuals without any chronic diseases will be included in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with type 2 diabetes mellitus who present to the Internal Medicine Outpatient Clinic of İzmir City Hospital will be included in this study. Healthy individuals without any chronic diseases will be included in this study.
Key inclusion criteria (5 listed)
- -
- Type 2 diabetes mellitus will be diagnosed based on the presence of any of the following criteria:
- Fasting plasma glucose ≥126 mg/dL (7.0 mmol/L)
- Hemoglobin A1c ≥6.5% (48 mmol/mol)
- Random plasma glucose ≥200 mg/dL (11.1 mmol/L) in the presence of classic symptoms of hyperglycemia, such as excessive thirst, frequent urination, and unexplained weight loss
Key exclusion criteria (18 listed)
- Pregnant or lactating women,
- Individuals diagnosed with known nephrolithiasis, glomerulonephritis or lupus nephritis, primary nephrotic syndrome, or other diagnosed kidney diseases,
- Individuals with parathyroid disease,
- Individuals with autoimmune diseases,
- Individuals with an acute infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lipoprotein a levels
Time frame: From enrollment to the end of treatment at 2 years
Participants' serum lipoprotein(a) [Lp(a)] levels will be analyzed using an ELISA kit.
29 secondary outcomes
Body Weight
Time frame: From enrollment to the end of treatment at 2 years
Height
Time frame: From enrollment to the end of treatment at 2 years
Body Mass Index
Time frame: From enrollment to the end of treatment at 2 years
Waist Circumference
Time frame: From enrollment to the end of treatment at 2 years
Hip Circumference
Time frame: From enrollment to the end of treatment at 2 years
Waist to Hip Ratio
Time frame: From enrollment to the end of treatment at 2 years
Waist to Height Ratio
Time frame: From enrollment to the end of treatment at 2 years
Mid-upper arm circumference
Time frame: From enrollment to the end of treatment at 2 years
Triceps skinfold thickness
Time frame: From enrollment to the end of treatment at 2 years
Fat-free mass
Time frame: From enrollment to the end of treatment at 2 years
Fat-free mass ratio
Time frame: From enrollment to the end of treatment at 2 years
Body Fat Mass
Time frame: From enrollment to the end of treatment at 2 years
Body Fat Ratio
Time frame: From enrollment to the end of treatment at 2 years
Total body water
Time frame: From enrollment to the end of treatment at 2 years
Total body water percentage
Time frame: From enrollment to the end of treatment at 2 years
Physical activity level
Time frame: From enrollment to the end of treatment at 2 years
Glucose
Time frame: From enrollment to the end of treatment at 2 years
HbA1c
Time frame: From enrollment to the end of treatment at 2 years
Triglyceride
Time frame: From enrollment to the end of treatment at 2 years
Total cholesterol
Time frame: From enrollment to the end of treatment at 2 years
Low Density Lipoprotein
Time frame: From enrollment to the end of treatment at 2 years
High Density Lipoprotein
Time frame: From enrollment to the end of treatment at 2 years
Homocysteine
Time frame: From enrollment to the end of treatment at 8 weeks
Visseral Obesity
Time frame: From enrollment to the end of treatment at 2 years
Insulin Resistance
Time frame: From enrollment to the end of treatment at 2 years
A Body Shape Index
Time frame: From enrollment to the end of treatment at 2 years
Framingham Risk Score
Time frame: From enrollment to the end of treatment at 2 years
Systematic Coronary Risk Evaluation
Time frame: From enrollment to the end of treatment at 2 years
Diet Quality
Time frame: From enrollment to the end of treatment at 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 20032323Clarke R, Peden JF, Hopewell JC, Kyriakou T, Goel A, Heath SC, Parish S, Barlera S, Franzosi MG, Rust S, Bennett D, Silveira A, Malarstig A, Green FR, Lathrop M, Gigante B, Leander K, de Faire U, Seedorf U, Hamsten A, Collins R, Watkins H, Farrall M; PROCARDIS Consortium. Genetic variants associated with Lp(a) lipoprotein level and coronary disease. N Engl J Med. 2009 Dec 24;361(26):2518-28. doi: 10.1056/NEJMoa0902604.
- Background: PubMed 28183512Tsimikas S. A Test in Context: Lipoprotein(a): Diagnosis, Prognosis, Controversies, and Emerging Therapies. J Am Coll Cardiol. 2017 Feb 14;69(6):692-711. doi: 10.1016/j.jacc.2016.11.042.
- Background: PubMed 30884849Caldeira-Araujo H, Ramos R, Florindo C, Rivera I, Castro R, Tavares de Almeida I. Homocysteine Metabolism in Children and Adolescents: Influence of Age on Plasma Biomarkers and Correspondent Genotype Interactions. Nutrients. 2019 Mar 16;11(3):646. doi: 10.3390/nu11030646.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to participant confidentiality and data privacy considerations.
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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.
Sibel D SEZER, PhD study chair
Izmir City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Health Adult Subjects, run by Izmir Democracy 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 5 inclusion and 18 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: opening soon, as of the sponsor's last update on 13 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerim K GÖKÜSTÜN, PhD (+905058699031, kerimkaangokustun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipoprotein a levels (time frame: From enrollment to the end of treatment at 2 years). 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 NCT07870122, which also lists 3 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 13 Oct 2026.