PPAR, RXR, and VDR Expressions in Diabetes

NCT04245982 | Completed DMC

• 1 other identifier: TOGU
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: Diabetes and periodontitis are two chronic inflammatory diseases sharing specific etiopathogenetic mechanisms, and both cause severe inflammation and destruction. The aim of the present study was to determine the receptor expressions of Peroxisome proliferative-activated receptor (PPAR)-γ, Retinoid X receptor (RXR)-α, Vitamin D receptor (VDR), and nuclear factor kappa B (NF-κB) expressions in healthy gingiva and diseased gingival samples with diabetes. Methods: 45 participants as 1; healthy controls (C), 2; periodontitis group (P), and 3; diabetes and periodontitis group (DP) were enrolled. Plaque index (PI), gingival index (GI) and clinical attachment levels (CAL) were recorded in all participants. Two gingival biopsies from each participant were obtained, and one underwent histological tissue processing while the other underwent RT-PCR analysis of nuclear receptors. Inflammatory and fibroblast cell counts, PPAR-γ, RXR-α, and VDR were evaluated. Results: Fibroblast cells were lowest in the DP group and highest in the healthy group. PPAR-γ, VDR, RXR, and NF-κB expressions were higher in the healthy controls in the RT-PCR analysis and similar in the other groups. Immunohistochemistry analysis also showed similar results. Conclusion: Results concluded that healthy gingival samples had higher PPAR-γ, RXR, VDR, and NF-κB expressions, and the immunohistochemistry results also supported this finding. The healthy gingiva contained higher fibroblast cells and lower inflammatory cells.

Conditions

Diabete Mellitus; Periodontitis

Keywords

Diabetes Mellitus; NF-κB; PPAR-γ; Periodontitis; RXR; VDR

Outcome Measures

Primary Outcomes (1)

• histological tissue evaluation

  Inflammatory and fibroblast cell counts, PPAR-γ, RXR-α, and VDR were evaluated.

  1 month.

Study Arms (3)

group (C)

healthy controls group

Procedure: Gingival biopsy

group (P)

periodontitis group

Procedure: Gingival biopsy

group (DP)

diabetes and periodontitis group

Procedure: Gingival biopsy

Interventions

Gingival biopsy PROCEDURE

Two gingival biopsies from each participant were collected.

group (C); group (DP); group (P)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Forty-two participants, 14 participants in each group, were enrolled in the study. The study groups were as follows. Healthy controls (C, mean age 41.05±1.80, seven men, seven women) Periodontitis patients with stage 3 grade B, (P, mean age 42.35±1.92, seven men, seven women) Patients with diabetes and periodontitis with stage 3 grade C, (DP, mean age 41.09±1.28, seven men, seven women)

You may qualify if:

• Periodontally healthy

You may not qualify if:

• Smokers
• Inflammatory state
• The existence of less than ten or over missing teeth
• drug use

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus; Periodontitis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Mehmet M Taskan, Phd,DDS

  TOGU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: January 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: December 31, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)