Efficacy of Semaglutide in Glycemic Control, Weight Loss, and Improving Lipidogram- Role of Baseline Vitamin D Levels

NCT07043361 | Completed FDA Drug

• 2 other identifiers: 0034-23-LEUNon applicable
• Study Type: observational
• Target: 5,300
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Semaglutide, a glucagon-like peptide-1 receptor agonist, is an established therapy for type 2 diabetes (T2D), offering robust glycemic control and weight reduction. Vitamin D has been implicated in metabolic regulation, yet its influence on semaglutide-induced outcomes remains unclear. Research Design and Methods: the investigators conducted a cross-sectional analysis of 5,300 adults with T2D, enrolled in Leumit Health Services, who initiated semaglutide therapy between February 1, 2019, and December 31, 2022. All patients had documented serum 25-hydroxyvitamin D \[25(OH)D\] levels prior to treatment initiation. Metabolic outcomes- including glycemic control (HbA1c), body mass index (BMI), and lipid profile- were assessed at 12 months. Associations between baseline 25(OH)D levels and metabolic changes were evaluated using multivariable regression models, adjusted for demographic and clinical covariates.

Conditions

Metabolic Disease

Outcome Measures

Primary Outcomes (3)

• relative weight loss measured by BMI

  testing semaglutide induced weight loss as a function of baseline vitamin D levels

  12 months from semaglutide initiation

• glycemic control using Hgb1C

  testing semaglutide induced glycemic control as a function of baseline vitamin D levels

  12 months from semaglutide initiation

• lipid control using LDL and TG

  testing semaglutide induced lipid control as a function of baseline vitamin D levels

  12 months from semaglutide initiation

Study Arms (1)

diabetic patients on semaglutide

we tested the relation between baseline vitamin D levels and metabolic amplification of semaglutide metabolic effects

Drug: semaglutide

Interventions

semaglutide DRUG

testing the effect of baseline vitamin D on metabolic effects of semaglutide

diabetic patients on semaglutide

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

diabetic patients on semaglutide treatment and with available baseline vitamin D levels

You may qualify if:

• Diabetes type II treated with semaglutide
• Available baseline vitamin D levels

You may not qualify if:

• Missing serum 25-hydroxyvitamin D (25\[OH\]D) data
• Pregnant or lactating females

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Leumit Health ccare system

Hadera, 333300, Israel

Location

Related Publications (17)

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MeSH Terms

Conditions

Metabolic Diseases

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• rami abo fanne, MD PhD

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: June 29, 2025
• Study Start: December 18, 2023
• Primary Completion: December 21, 2024
• Study Completion: April 30, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)