Vitamin D Status and Lipid Profile in Obese Adults With Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSinai University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Type 1 diabetes mellitus.
Pregnancy.
Known chronic kidney disease.
Chronic liver disease.
Trial population
Adults with obesity and established type 2 diabetes mellitus attending an outpatient diabetes clinic.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 2 trial groupsGroup A: Lower Vitamin D Status Group
Group B: Higher Vitamin D Status Group
Trial outcomes
Primary outcomes
1
Lipid Profile According to Serum 25-Hydroxyvitamin D Status
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)
Time frame
At the baseline study visit (single assessment)Secondary outcomes
1
Fasting Blood Glucose
Measurement (mg/dL) at baseline visit to assess glycemic control in relation to vitamin D status.
Time frame
At the baseline study visit (single assessment)2
Postprandial Blood Glucose
Measurement (mg/dL) at baseline visit
Time frame
At the baseline study visit (single assessment)3
Glycated Hemoglobin (HbA1c)
Measurement (%) at baseline visit.
Time frame
At the baseline study visit (single assessment)4
Serum Insulin
Measurement (µIU/mL) at baseline visit.
Time frame
At the baseline study visit (single assessment)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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