An observational study in Type 2 Diabetes Mellitus and Health Adult Subjects, sponsored by Izmir Democracy University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Izmir Democracy University · Observational
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.
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 209 is below the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Izmir Democracy University is the lead sponsor of 76 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Inclusion Criteria:
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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
Exclusion Criteria:
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,
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.
Exclusion criteria for healthy individuals:
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.
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 without any chronic diseases will be included in this study.
Lipoprotein a levels
Participants' serum lipoprotein(a) \[Lp(a)\] levels will be analyzed using an ELISA kit.
Time frame: From enrollment to the end of treatment at 2 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 2 years
Triceps skinfold thickness
Participants' triceps skinfold thickness will be measured.
Time frame: From enrollment to the end of treatment at 2 years
Fat-free mass
Fat-free mass (FFM) will be measured using bioelectrical impedance analysis
Time frame: 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
Time frame: From enrollment to the end of treatment at 2 years
Body Fat Mass
Body fat mass will be measured using bioelectrical impedance analysis
Time frame: From enrollment to the end of treatment at 2 years
Body Fat Ratio
Body fat ratio will be measured using bioelectrical impedance analysis
Time frame: From enrollment to the end of treatment at 2 years
Total body water
Total body water will be measured using bioelectrical impedance analysis
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment at 2 years
Glucose
Participants' blood glucose levels will be assessed.
Time frame: From enrollment to the end of treatment at 2 years
HbA1c
Participants' blood HbA1c levels will be assessed.
Time frame: From enrollment to the end of treatment at 2 years
Triglyceride
Participants' blood triglyceride levels will be assessed.
Time frame: From enrollment to the end of treatment at 2 years
Total cholesterol
Participants' blood total cholesterol levels will be assessed
Time frame: From enrollment to the end of treatment at 2 years
Low Density Lipoprotein
Participants' blood low density lipoprotein levels will be assessed
Time frame: From enrollment to the end of treatment at 2 years
High Density Lipoprotein
Participants' blood high density lipoprotein levels will be assessed
Time frame: From enrollment to the end of treatment at 2 years
Homocysteine
Serum homocysteine levels will be determined using ELISA kits.
Time frame: From enrollment to the end of treatment at 8 weeks
Visseral Obesity
Participants' visceral obesity levels will be assessed using the Visceral Adiposity Index
Time frame: From enrollment to the end of treatment at 2 years
Insulin Resistance
Participants' insulin resistance will be assessed using the triglyceride-glucose index.
Time frame: 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)).
Time frame: From enrollment to the end of treatment at 2 years
Framingham Risk Score
Cardiovascular disease risk will be assessed using the Framingham Risk Score.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 2 years
Diet Quality
Diet quality will be assessed using the Healthy Eating Index
Time frame: From enrollment to the end of treatment at 2 years
Plan to share: No — Individual participant data will not be shared due to participant confidentiality and data privacy considerations.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Izmir Democracy University