Relationship Between Insulin Resistance and Vitamin D in Type 2 Diabetes Mellitus (DM)
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. Basic parameters: No limits · 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 →
Unsure about the terms? Read our patient guide →
Official title
Impact of Vitamin D Deficiency on Insulin Resistance Assessed by Triglyceride Glucose Index in Type 2 Diabetic Patients
Overview
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).
Primary outcome measures
- Impact of vitamin D level on insulin resistance [Time frame: baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Lee SH, Park SY, Choi CS. Insulin Resistance: From Mechanisms to Therapeutic Strategies. Diabetes Metab J. 2022 Jan;46(1):15-37. doi: 10.4093/dmj.2021.0280. Epub 2021 Dec 30. PMID 34965646
- Hill MA, Yang Y, Zhang L, Sun Z, Jia G, Parrish AR, Sowers JR. Insulin resistance, cardiovascular stiffening and cardiovascular disease. Metabolism. 2021 Jun;119:154766. doi: 10.1016/j.metabol.2021.154766. Epub 2021 Mar 22. PMID 33766485
Identifiers
NCT: NCT07467161 · Type 2 Diabetes mellitus (DM)