300 Participants Needed

Investigational Procedure for Type 2 Diabetes and Gum Disease

Recruiting at 5 trial locations
TT
Overseen ByTrial Transparency email recommended (Toll free for US & Canada)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on anticoagulants, systemic antibiotics, immunomodulators, or long-term corticosteroids, you may need to stop them before joining the study.

What data supports the effectiveness of the treatment for Type 2 Diabetes and Gum Disease?

Research shows that treating gum disease in people with type 2 diabetes can help reduce inflammation and improve blood sugar control. Studies have found that non-surgical periodontal therapy can lead to better management of diabetes and improve overall health.12345

Is the investigational procedure for type 2 diabetes and gum disease safe for humans?

The studies reviewed focus on non-surgical periodontal treatments for people with type 2 diabetes and gum disease, which are generally considered safe. These treatments have been evaluated for their effects on gum health and blood sugar control, but no specific safety concerns were reported in the studies.12467

How is the investigational treatment for type 2 diabetes and gum disease different from other treatments?

The investigational treatment is unique because it focuses on the relationship between type 2 diabetes and gum disease, potentially addressing both conditions simultaneously. Unlike standard treatments that may target only one condition, this approach could improve oral health and help manage diabetes by reducing inflammation and improving metabolic control.14789

What is the purpose of this trial?

The purpose of this study is to learn about the interactions of markers of type 2 diabetes (T2DM) and periodontitis (PD). Study VPE00001 is a multi-center cross-sectional study. Participants will be categorized based on point-of-care hemoglobin A1c (HbA1c) and periodontal disease (PD) staging into 9 subgroups. The key objectives of the study are:* To evaluate immune signatures in well-characterized populations with or without PD and/or T2DM* To evaluate baseline clinical biomarkers of T2DM and PD in well-characterized populations* To evaluate the influence of clinical, immunological, and microbiological biomarkers on the bidirectional relationship between T2DM and PD

Eligibility Criteria

This study is for men and women aged 30-70 with a BMI under 40. It's open to those without diabetes or pre-diabetes, as well as those who've had type 2 diabetes for at least six months. Participants can also have varying stages of gum disease but must meet specific criteria based on their hemoglobin A1c levels.

Inclusion Criteria

Body mass index < 40 kg/m2
I am between 30 and 70 years old.
I either have healthy gums, mild/moderate gum disease, or severe gum disease diagnosed recently.
See 1 more

Exclusion Criteria

I have not received any blood products or immune globulins in the last 3 months.
I have had cancer or leukemia in the past year.
I have had a deep dental cleaning in the last 3 months.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 30 days
1 visit (in-person)

Specimen Collection

Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) are collected from participants

Single visit
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after specimen collection

4 weeks

Treatment Details

Interventions

  • Investigational Procedure
Trial Overview The trial is investigating how certain biomarkers in the blood and gums interact in people with type 2 diabetes and periodontitis (gum disease). Participants will be divided into nine groups based on their diabetes control and gum disease severity to study these interactions.
Participant Groups
9Treatment groups
Experimental Treatment
Group I: Participant with Stage III/Stage IV Periodontal Disease with no Type 2 Diabetes MellitusExperimental Treatment1 Intervention
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Group II: Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 8.0-10.0Experimental Treatment1 Intervention
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Group III: Participant with Stage III/Stage IV Periodontal Disease with Hemoglobin A1c level 6.5-7.8Experimental Treatment1 Intervention
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Group IV: Participant with Stage I/Stage II Periodontal Disease with no Type 2 Diabetes MellitusExperimental Treatment1 Intervention
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Group V: Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 8.0-10.0Experimental Treatment1 Intervention
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Group VI: Participant with Stage I/Stage II Periodontal Disease with Hemoglobin A1c level 6.5-7.8Experimental Treatment1 Intervention
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Group VII: Healthy Participant or Participant with Gingivitis with no Type 2 Diabetes MellitusExperimental Treatment1 Intervention
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Group VIII: Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 8.0-10.0Experimental Treatment1 Intervention
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected
Group IX: Healthy Participant or Participant with Gingivitis with Hemoglobin A1c level 6.5-7.8Experimental Treatment1 Intervention
Participants will be screened via periodontal exam for periodontal disease staging and point-of-care hemoglobin A1c (HbA1c) testing for type 2 diabetes (T2DM) status. Blood, saliva, subgingival plaque, and gingival crevicular fluid (GCF) will be collected

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sanofi Pasteur, a Sanofi Company

Lead Sponsor

Trials
429
Recruited
6,140,000+
Paul Hudson profile image

Paul Hudson

Sanofi Pasteur, a Sanofi Company

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Dr. Thomas Triomphe profile image

Dr. Thomas Triomphe

Sanofi Pasteur, a Sanofi Company

Chief Medical Officer since 2020

MD from Tehran University of Medical Sciences

Findings from Research

In a study of 15 type 2 diabetes patients with periodontitis, periodontal initial therapy significantly reduced levels of glycosylated hemoglobin (HbA1C) and circulating tumor necrosis factor-alpha (TNF-alpha) after 4-6 weeks, indicating improved diabetes control.
The therapy effectively lowered inflammation and blood sugar levels, suggesting that treating periodontal disease may have beneficial effects on managing type 2 diabetes, although it did not significantly change body mass index (BMI) or cholesterol levels.
[The effect of periodontal initial therapy on circulating TNF-alpha and HbA1C in type 2 diabetes patients with periodontitis].Yang, PS., Wang, Y., Qi, XM., et al.[2022]
In a study of 88 patients with chronic periodontitis and uncontrolled type 2 diabetes, immediate non-surgical periodontal therapy led to significantly better clinical and metabolic outcomes after 3 months compared to delayed therapy.
The treatment, which included scaling, root planning, and a combination of antibiotics (amoxicillin and metronidazole), not only improved periodontal health but also positively impacted metabolic markers like glycated hemoglobin (HbA1c).
The effects of non-surgical periodontal therapy on glycemic control in diabetic patients: A randomized controlled trial.El-Makaky, Y., Shalaby, HK.[2022]
In a study of 83 adults with type 2 diabetes and 75 controls, periodontal treatment significantly reduced systemic inflammation markers after 12 months, particularly in those with diabetes and periodontitis.
Individuals with diabetes and periodontitis had higher systemic inflammation levels compared to non-diabetic controls, but after treatment, they experienced a greater reduction in inflammation, highlighting the importance of periodontal care in managing diabetes-related inflammation.
Treatment of periodontitis reduces systemic inflammation in type 2 diabetes.Preshaw, PM., Taylor, JJ., Jaedicke, KM., et al.[2022]

References

[The effect of periodontal initial therapy on circulating TNF-alpha and HbA1C in type 2 diabetes patients with periodontitis]. [2022]
The effects of non-surgical periodontal therapy on glycemic control in diabetic patients: A randomized controlled trial. [2022]
Treatment of periodontitis reduces systemic inflammation in type 2 diabetes. [2022]
Evaluation of periodontal status and effectiveness of non-surgical treatment in patients with type 2 diabetes mellitus in Taiwan for a 1-year period. [2022]
The effects of periodontal treatment on diabetic patients: The DIAPERIO randomized controlled trial. [2022]
Metformin and risk of gingival/periodontal diseases in diabetes patients: A retrospective cohort study. [2022]
Microbiological changes after periodontal therapy in diabetic patients with inadequate metabolic control. [2019]
Oral microbiota in periodontitis patients with and without type 2 diabetes mellitus and their shifts after the nonsurgical periodontal therapy. [2023]
Evaluation of clinical and metabolic changes after non surgical periodontal treatment of type 2 diabetes mellitus patients: A clinico biochemical study. [2021]
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