Vitamin D Status and Lipid Profile in Obese Adults With Type 2 Diabetes

NCT07729553 | Not Yet Recruiting DMC

• 1 other identifier: IRB00014233-37
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus; Obesity; Dyslipidemia; Vitamin D Deficiency

Keywords

Type 2 Diabetes Mellitus; Obesity; Vitamin D Deficiency; Dyslipidemia; Lipid Metabolism; Cardiometabolic Risk

Outcome Measures

Primary Outcomes (1)

• 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)

  At the baseline study visit (single assessment)

Secondary Outcomes (4)

• Fasting Blood Glucose

  At the baseline study visit (single assessment)

• Postprandial Blood Glucose

  At the baseline study visit (single assessment)

• Glycated Hemoglobin (HbA1c)

  At the baseline study visit (single assessment)

• Serum Insulin

  At the baseline study visit (single assessment)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with obesity and established type 2 diabetes mellitus attending an outpatient diabetes clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sinai University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Dyslipidemias; Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lipid Metabolism Disorders; Avitaminosis; Deficiency Diseases; Malnutrition

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: July 25, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share