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Not Yet RecruitingNCT07467161

Relationship Between Insulin Resistance and Vitamin D in Type 2 Diabetes Mellitus (DM)

Impact of Vitamin D Deficiency on Insulin Resistance Assessed by Triglyceride Glucose Index in Type 2 Diabetic Patients

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
165 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
Healthy volunteers

Summary

The primary aim of the study is to evaluate the association between vitamin D levels and triglyceride-glucose index as a marker of insulin resistance in patients with type 2 DM.

Detailed description

All eligible patients will be asked to participate in the study after counseling and written consent. The following data will be collected. I) Demographic \& baseline data of the participants: * Gender, age, residence (rural or urban), weight and height. * Smoking or alcohol consumption. II) Medical History of the participants: * Regarding Type 2 DM: onset of diagnosis, current medications, dosage of medications, adherence to treatment, complications of DM. * Other medical disorders: hypertension, thyroid disease. III) Clinical and laboratory assessment of the participants: * Vital signs: Pulse, blood pressure (systolic \& diastolic), temperature and respiratory rate. * Body mass index (BMI): calculated as weight in kilograms divided by the square of height in meters (kg/ m²). * Waist circumference of the participants. * All participants will be fasting overnight (12 hours), and the blood samples will be drawn in the next morning. All blood biomarkers will be tested in the same laboratory. We will measure the following: Fasting blood glucose (FBG), glycosylated hemoglobin (HbA1c), 25-hydroxyvitamin D, albumin, total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL), low-density lipoprotein cholesterol (LDL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), urea nitrogen (BUN), creatinine (S.cr) and uric acid (UA). * The serum concentration of 25(OH)D will be measured using electro-chemi-luminescence immunoassay. * Triglyceride-glucose index (TyG) will be calculated as (fasting triglyceride (mg/dL) x fasting glucose (mg/dL)/2). * Vitamin D deficiency (VDD) is defined as plasma 25(OH)D \< 20 ng/mL; values 20-30 ng/mL are considered insufficiency; and values \> 30 ng/mL are considered sufficiency. * For those with vitamin D deficiency (25(OH)D \< 20 ng/mL); vitamin D supplementation will be added for correction. * Follow up of the participants after 3 months: vitamin D level (25-hydroxyvitamin D), Triglyceride-glucose index (TyG), waist circumference and glycemic control reflected by glycosylated hemoglobin (HbA1c).

Conditions

Timeline

Start date
2026-03-01
Primary completion
2028-01-01
Completion
2028-03-01
First posted
2026-03-12
Last updated
2026-03-13

Source: ClinicalTrials.gov record NCT07467161. Inclusion in this directory is not an endorsement.