Type 2 Diabetes MellitusVILD-T2DNCT07729553
Vitamin D Status and Lipid Profile in Obese Adults With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus and Obesity, run by Sinai University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Obesity, Dyslipidemia
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2026to 28 Feb 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with obesity and established type 2 diabetes mellitus attending an outpatient diabetes clinic.
Who may be able to join
- 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.
- Availability of lipid profile and glycemic laboratory parameters.
- Ability and willingness to provide written informed consent.
Who cannot join
- Type 1 diabetes mellitus.
- Pregnancy.
- Known chronic kidney disease.
- Chronic liver disease.
- Active malignancy.
- Acute infection or inflammatory disease.
- Conditions affecting gastrointestinal absorption.
- Use of medications or supplements that substantially alter vitamin D metabolism (when applicable).
About this study
Official title: Association Between Serum 25-Hydroxyvitamin D Status and Lipid Profile Among Obese Adults With Type 2 Diabetes Mellitus: A Cross-Sectional Study
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.
Read the detailed description
Detailed Description
This prospective, single-center, cross-sectional observational study is designed to investigate the association between serum 25-hydroxyvitamin D [25(OH)D] status and lipid profile parameters among obese adults with established type 2 diabetes mellitus (T2DM).
The study will recruit adult participants with obesity and T2DM attending an outpatient diabetes clinic in Cairo, Egypt. Eligible participants will undergo a baseline clinical and laboratory assessment after providing written informed consent.
The primary objective of this study is to evaluate whether serum 25(OH)D concentrations are associated with lipid profile parameters, including total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).
Secondary objectives include evaluating the association between serum vitamin D status and glycemic characteristics, including fasting blood glucose, postprandial blood glucose, glycated hemoglobin (HbA1c), and serum insulin levels.
During the study visit, demographic and clinical data will be collected, including age, sex, diabetes duration, body mass index (BMI), and relevant medical history. Anthropometric measurements and blood pressure assessment will be performed. Fasting blood samples will be collected for biochemical analyses, including serum 25(OH)D concentration, glucose parameters, insulin, and lipid profile measurements.
Participants will be categorized according to their serum 25(OH)D status based on predefined criteria. Statistical analyses will be performed to assess differences between vitamin D status groups and to evaluate correlations between serum 25(OH)D concentrations and cardiometabolic parameters.
No intervention, medication assignment, or vitamin D supplementation will be administered as part of this study. The study is observational in nature and aims to identify associations between vitamin D status and metabolic characteristics among obese adults with T2DM.
All procedures will be conducted according to the approved study protocol and ethical principles for research involving human participants. Written informed consent will be obtained from all participants before enrollment.
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Dyslipidemia, Vitamin D Deficiency
- Keywords
- Type 2 Diabetes Mellitus, Obesity; Vitamin D Deficiency; Dyslipidemia; Lipid Metabolism, Cardiometabolic Risk
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Dyslipidemias, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lower Vitamin D Status Group | Participants with obesity and established type 2 diabetes mellitus who have lower serum 25-hydroxyvitamin D [25(OH)D] concentrations according to the predefined study criteria. Vitamin D deficiency is defined as serum 25(OH)D concentration below 20 ng/mL. Participants in this group will undergo clinical and laboratory assessments, including lipid profile and glycemic measurements, to evaluate metabolic characteristics associated with lower vitamin D status. | |
| Higher Vitamin D Status Group | Participants with obesity and established type 2 diabetes mellitus who have higher serum 25-hydroxyvitamin D [25(OH)D] concentrations according to the predefined study criteria. Participants in this group will undergo the same clinical and laboratory assessments, including lipid profile and glycemic measurements, for comparison with the lower vitamin D status group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At the baseline study visit (single assessment)
Secondary outcomes (4)
Fasting Blood Glucose
Measurement (mg/dL) at baseline visit to assess glycemic control in relation to vitamin D status.
Measured: At the baseline study visit (single assessment)
Postprandial Blood Glucose
Measurement (mg/dL) at baseline visit
Measured: At the baseline study visit (single assessment)
Glycated Hemoglobin (HbA1c)
Measurement (%) at baseline visit.
Measured: At the baseline study visit (single assessment)
Serum Insulin
Measurement (µIU/mL) at baseline visit.
Measured: At the baseline study visit (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start25 Jul 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Gomaa Atiaa, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729553
- Sponsor's protocol ID
- IRB00014233-37
- Acronym
- VILD-T2D
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. The study data contain potentially identifiable health information, and participant consent and institutional ethical approval did not include unrestricted public release of individual-level data. Requests for data access may be considered by the corresponding author upon reasonable request and subject to institutional and ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Serum 25-Hydroxyvitamin D Status and Lipid Profile Among Obese Adults With Type 2 Diabetes Mellitus: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07729553
- Acronym / sponsor ID
- VILD-T2D / IRB00014233-37
- Conditions
- Type 2 Diabetes Mellitus, Obesity, Dyslipidemia, Vitamin D Deficiency
- Keywords
- Type 2 Diabetes Mellitus, Obesity; Vitamin D Deficiency; Dyslipidemia; Lipid Metabolism, Cardiometabolic Risk
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 25 Jul 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 27 Jul 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.
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.
Detailed description
Detailed Description
This prospective, single-center, cross-sectional observational study is designed to investigate the association between serum 25-hydroxyvitamin D [25(OH)D] status and lipid profile parameters among obese adults with established type 2 diabetes mellitus (T2DM).
The study will recruit adult participants with obesity and T2DM attending an outpatient diabetes clinic in Cairo, Egypt. Eligible participants will undergo a baseline clinical and laboratory assessment after providing written informed consent.
The primary objective of this study is to evaluate whether serum 25(OH)D concentrations are associated with lipid profile parameters, including total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).
Secondary objectives include evaluating the association between serum vitamin D status and glycemic characteristics, including fasting blood glucose, postprandial blood glucose, glycated hemoglobin (HbA1c), and serum insulin levels.
During the study visit, demographic and clinical data will be collected, including age, sex, diabetes duration, body mass index (BMI), and relevant medical history. Anthropometric measurements and blood pressure assessment will be performed. Fasting blood samples will be collected for biochemical analyses, including serum 25(OH)D concentration, glucose parameters, insulin, and lipid profile measurements.
Participants will be categorized according to their serum 25(OH)D status based on predefined criteria. Statistical analyses will be performed to assess differences between vitamin D status groups and to evaluate correlations between serum 25(OH)D concentrations and cardiometabolic parameters.
No intervention, medication assignment, or vitamin D supplementation will be administered as part of this study. The study is observational in nature and aims to identify associations between vitamin D status and metabolic characteristics among obese adults with T2DM.
All procedures will be conducted according to the approved study protocol and ethical principles for research involving human participants. Written informed consent will be obtained from all participants before enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Vitamin D Status Group | – | –Participants with obesity and established type 2 diabetes mellitus who have lower serum 25-hydroxyvitamin D [25(OH)D] concentrations according to the predefined study criteria. Vitamin D deficiency is defined as serum 25(OH)D concentration below 20 ng/mL. Participants in this group will undergo clinical and laboratory assessments, including lipid profile and glycemic measurements, to evaluate metabolic characteristics associated with lower vitamin D status. |
| Higher Vitamin D Status Group | – | –Participants with obesity and established type 2 diabetes mellitus who have higher serum 25-hydroxyvitamin D [25(OH)D] concentrations according to the predefined study criteria. Participants in this group will undergo the same clinical and laboratory assessments, including lipid profile and glycemic measurements, for comparison with the lower vitamin D status group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with obesity and established type 2 diabetes mellitus attending an outpatient diabetes clinic.
Key inclusion criteria (6 listed)
- 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.
- Availability of lipid profile and glycemic laboratory parameters.
Key exclusion criteria (8 listed)
- Type 1 diabetes mellitus.
- Pregnancy.
- Known chronic kidney disease.
- Chronic liver disease.
- Active malignancy.
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
Lipid Profile According to Serum 25-Hydroxyvitamin D Status
Time frame: At the baseline study visit (single assessment)
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)
4 secondary outcomes
Fasting Blood Glucose
Time frame: At the baseline study visit (single assessment)
Postprandial Blood Glucose
Time frame: At the baseline study visit (single assessment)
Glycated Hemoglobin (HbA1c)
Time frame: At the baseline study visit (single assessment)
Serum Insulin
Time frame: At the baseline study visit (single assessment)
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 27 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. The study data contain potentially identifiable health information, and participant consent and institutional ethical approval did not include unrestricted public release of individual-level data. Requests for data access may be considered by the corresponding author upon reasonable request and subject to institutional and ethical approval.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Obesity, run by Sinai 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 6 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 27 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipid Profile According to Serum 25-Hydroxyvitamin D Status (time frame: At the baseline study visit (single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2026.