Vitamin D Status and Lipid Profile in Obese Adults With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Mellitus, Obesity, Dyslipidemia, Vitamin D Deficiency. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association Between Serum 25-Hydroxyvitamin D Status and Lipid Profile Among Obese Adults With Type 2 Diabetes Mellitus: A Cross-Sectional Study
Overview
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.
Primary outcome measures
- Lipid Profile According to Serum 25-Hydroxyvitamin D Status [Time frame: At the baseline study visit (single assessment)]
Secondary outcome measures (4)
- Fasting Blood Glucose [Time frame: At the baseline study visit (single assessment)]
- Postprandial Blood Glucose [Time frame: At the baseline study visit (single assessment)]
- Glycated Hemoglobin (HbA1c) [Time frame: At the baseline study visit (single assessment)]
- Serum Insulin [Time frame: At the baseline study visit (single assessment)]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07729553 · IRB00014233-37