Chromogranin-A-Derived Peptides and Periodontitis in Diab... | NCT00399620

Studies
Chromogranin-A-Derived Peptides and Periodontitis in Diabetic Patients

NCT00399620

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jan 12, 2009Estimated

Enrollment

90Estimated

Phase

Not Applicable

Conditions

Periodontitis and Diabetitis

Interventions

Gingival crevicular fluid samples (this procedure is added to the subject usual medical follow-up).

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 14, 2006

First Submission Date that Met QC Criteria

Nov 14, 2006

First Posted Date

Nov 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2009

Last Update Posted Date

Jan 12, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Periodontitis is a chronic disease of the supporting tissue of the teeth, characterized by bleeding and inflamed gingival, resorption of alveolar bone. This disease has a significant impact of the quality of life as the teeth become progressively mobile and may fall out spontaneously if no treatment is provided. Periodontal disease has been cited as the sixth complication of diabetes mellitus.Chromogranins / secretogranins are a family of proteins present in nervous endocrine and immune cells, released with catecholamines during stress situations. Chromogranin A (CGA) is the major member of this family.The aim of this study is to determine the level of CGA and its derived peptides in the gingival crevicular fluid (GCF) of health or diabetic patients with and without periodontitis.Then, we want to determine the antimicrobial activity of these peptides.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Name	Type	Description	Arm Group Labels	Other Names
Gingival crevicular fluid samples (this procedure is added to the subject usual medical follow-up).	Procedure

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients from 20 to 80 years old
A minimum of 10 teeth
Healthy volunteers or diabetic patients with or without periodontitis

Exclusion criteria:

a course of antibiotics
a fungicidal therapy
a corticotherapy
a hormone therapy
a pregnancy
persons under guardianship

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martine Soell, MD	Contact	33 6 74 86 67 36		martine.soell@chru-strasbourg.fr

Overall Officials

Name	Affiliation	Role
Martine Soell, MD	Hôpitaux Universitaires de Strasbourg	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Département de Parodontologie - Hôpital Civil	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D010518	Periodontitis
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided