Dyslipidemia, Obesity, Type 2 Diabetes Mellitus, Vitamin D Deficiency
Conditions
Keywords
Type 2 Diabetes Mellitus, Obesity; Vitamin D Deficiency; Dyslipidemia; Lipid Metabolism, Cardiometabolic Risk
Brief summary
This prospective, single-center, cross-sectional observational study aims to evaluate the association between serum 25-hydroxyvitamin D concentrations and lipid profile parameters among adults with obesity and established type 2 diabetes mellitus. A total of 160 participants will be recruited from an outpatient diabetes clinic in Cairo, Egypt. Each participant will undergo a single clinical, anthropometric, and laboratory assessment. No intervention or treatment will be assigned by the investigators.
Detailed description
\*\*Detailed Description\*\* This prospective, single-center, cross-sectional observational study is designed to investigate the association between serum 25-hydroxyvitamin D \[25(OH)D\] status and lipid profile parameters among obese adults with established type 2 diabetes mellitus (T2DM). The study will recruit adult participants with obesity and T2DM attending an outpatient diabetes clinic in Cairo, Egypt. Eligible participants will undergo a baseline clinical and laboratory assessment after providing written informed consent. The primary objective of this study is to evaluate whether serum 25(OH)D concentrations are associated with lipid profile parameters, including total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). Secondary objectives include evaluating the association between serum vitamin D status and glycemic characteristics, including fasting blood glucose, postprandial blood glucose, glycated hemoglobin (HbA1c), and serum insulin levels. During the study visit, demographic and clinical data will be collected, including age, sex, diabetes duration, body mass index (BMI), and relevant medical history. Anthropometric measurements and blood pressure assessment will be performed. Fasting blood samples will be collected for biochemical analyses, including serum 25(OH)D concentration, glucose parameters, insulin, and lipid profile measurements. Participants will be categorized according to their serum 25(OH)D status based on predefined criteria. Statistical analyses will be performed to assess differences between vitamin D status groups and to evaluate correlations between serum 25(OH)D concentrations and cardiometabolic parameters. No intervention, medication assignment, or vitamin D supplementation will be administered as part of this study. The study is observational in nature and aims to identify associations between vitamin D status and metabolic characteristics among obese adults with T2DM. All procedures will be conducted according to the approved study protocol and ethical principles for research involving human participants. Written informed consent will be obtained from all participants before enrollment.
Interventions
None listed
Sponsors
Sinai University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Established diagnosis of type 2 diabetes mellitus (T2DM) according to standard diagnostic criteria. * Obesity based on body mass index (BMI) criteria. * Availability of serum 25-hydroxyvitamin D \[25(OH)D\] measurement. * Availability of lipid profile and glycemic laboratory parameters. * Ability and willingness to provide written informed consent.
Exclusion criteria
* Type 1 diabetes mellitus. * Pregnancy. * Known chronic kidney disease. * Chronic liver disease. * Active malignancy. * Acute infection or inflammatory disease. * Conditions affecting gastrointestinal absorption. * Use of medications or supplements that substantially alter vitamin D metabolism (when applicable).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lipid Profile According to Serum 25-Hydroxyvitamin D Status | At the baseline study visit (single assessment) | Measurement of serum lipid parameters including: Total cholesterol (mg/dL) Triglycerides (mg/dL) High-density lipoprotein cholesterol (HDL-C, mg/dL) Low-density lipoprotein cholesterol (LDL-C, mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood Glucose | At the baseline study visit (single assessment) | Measurement (mg/dL) at baseline visit to assess glycemic control in relation to vitamin D status. |
| Postprandial Blood Glucose | At the baseline study visit (single assessment) | Measurement (mg/dL) at baseline visit |
| Glycated Hemoglobin (HbA1c) | At the baseline study visit (single assessment) | Measurement (%) at baseline visit. |
| Serum Insulin | At the baseline study visit (single assessment) | Measurement (µIU/mL) at baseline visit. |
Outcome results
None listed