Type 2 DiabetesDMNCT07467161
Relationship Between Insulin Resistance and Vitamin D in Type 2 Diabetes Mellitus (DM)
An observational study of Type 2 Diabetes, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with type 2 DM
Who may be able to join
- Patients with type 2 DM diagnosed based on American Diabetes Association criteria.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Vitamin D Deficiency on Insulin Resistance Assessed by Triglyceride Glucose Index in Type 2 Diabetic Patients
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.
Read the detailed description
All eligible patients will be asked to participate in the study after counseling and written consent. The following data will be collected.
- 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
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of vitamin D level on insulin resistance
Evaluation of the association between vitamin D levels and triglyceride-glucose index as a marker of insulin resistance in patients with type 2 DM
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Magdy Ahmed Mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467161
- Sponsor's protocol ID
- Type 2 Diabetes mellitus (DM)
- Acronym
- DM
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34965646Hill 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.
PubMed 33766485
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Deficiency on Insulin Resistance Assessed by Triglyceride Glucose Index in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT07467161
- Acronym / sponsor ID
- DM / Type 2 Diabetes mellitus (DM)
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with type 2 DM
Key inclusion criteria (1 listed)
- Patients with type 2 DM diagnosed based on American Diabetes Association criteria.
Key exclusion criteria (8 listed)
- Patients with type 1 DM or other types of diabetes.
- Patients with complications of acute DM.
- Pregnant females.
- Malignancy.
- BMI > 35 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 34965646Lee 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.
- Background: PubMed 33766485Hill 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Magdy Ahmed Mohammed, MD (+201098777997, dr.sara54.sm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of vitamin D level on insulin resistance (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07467161, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.