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NCT Number: NCT07467161

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

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.

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Key information

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with type 2 DM diagnosed based on American Diabetes Association criteria.

Exclusion criteria

  • Patients with type 1 DM or other types of diabetes.
  • Patients with complications of acute DM.
  • Pregnant females.
  • Malignancy.
  • BMI > 35 kg/m²
  • Major co-morbidities as end-stage renal disease or liver cell failure.
  • Patients on lipid lowering therapy.
  • Patients on vitamin D supplementation.

Treatment and study plan

Primary outcomes

  1. Impact of vitamin D level on insulin resistance

    Time frame: baseline

    Evaluation of the association between vitamin D levels and triglyceride-glucose index as a marker of insulin resistance in patients with type 2 DM

Study contacts

Contact information is provided by the study sponsor or research team.

Hanaa Mohamed Riad, MD

CONTACT

[email protected]

+201094608083

Sara Magdy Ahmed Mohammed, MD

CONTACT

[email protected]

+201098777997

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: DM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 12, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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