Type 2 Diabetes MellitusNCT01467674
The Effect Of Glycemic Control On Malondialdehyde, Glutathione Peroxidase, Glutathione And Paraoxonase
An observational study of Type 2 Diabetes Mellitus and Chronic Periodontitis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the impact of glycemic control on clinical periodontal status, levels of malondialdehyde (MDA), glutathione peroxidase (GSH-Px), reduced glutathione (GSH) and paraoxonase (PON) activity in gingival crevicular fluid (GCF) and blood samples of type 2 diabetes mellitus (T2DM)… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Chronic Periodontitis
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2008to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with T2DM were recruited among those attending Suleyman Demirel University (SDU) Faculty of Medicine, Department of Endocrinology and non-diabetic individuals were recruited among those attending SDU Faculty of Dentistry, Department of Periodontology.
Who may be able to join
- to present T2DM diagnosis by an endocrinologist for at least the past 5 years
- diagnosis of CP was based on the clinical and radiographic criteria proposed by the 1999 World Workshop for Classification of Periodontal Diseases and Conditions
Who cannot join
- pregnancy
- lactation
- current smoking or smoking within the past 2 years, periodontal therapy in the previous 6 months
- antibiotic and/or antimicrobial therapies in the previous 3 months
- existence of serious diabetic complications or any pathology such as haemoglobinopathy which would affect haemoglobin profile
- diagnosis of another major medical pathology, middle or upper-level obesity according to WHO classification
- current anti-hyperlipidemic therapy
- non-T2DM patients with abnormal values of glucose and lipid metabolism parameters, major medical pathology and family history of DM
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Malondialdehyde And Antioxidant Levels In Chronic Periodontitis Patients With Type 2 Diabetes Mellitus Under Different Stages Of Metabolic Control
The aim of this study was to investigate the impact of glycemic control on clinical periodontal status, levels of malondialdehyde (MDA), glutathione peroxidase (GSH-Px), reduced glutathione (GSH) and paraoxonase (PON) activity in gingival crevicular fluid (GCF) and blood samples of type 2 diabetes mellitus (T2DM) patients with chronic periodontitis (CP).
Read the detailed description
Reactive oxygen species (ROS) are products of normal cellular metabolism and play beneficial role in physiological functions. Overproduction of ROS and/or deficiency of enzymatic or non-enzymatic antioxidants, termed as oxidative stress, is involved in many pathological conditions such as Diabetes mellitus (DM) and chronic periodontitis (CP).
Several researches revealed that DM, with many determinants such as level of glycemic control, stands as a strong risk factor for periodontal diseases. On the other side, periodontal diseases induce an elevated chronic inflammatory state and exacerbated insulin resistance.
In the present study, the investigators examined the effect of glycemic control level on clinical periodontal status, levels of MDA, GSH-Px, GSH and PON activity in gingival crevicular fluid and blood samples of CP patients with T2DM.
- Conditions
- Type 2 Diabetes Mellitus, Chronic Periodontitis
- Keywords
- Diabetes mellitus, Chronic periodontitis, Malondialdehyde, Glutathione peroxidase, Paraoxonase
- Medical subject headings
- Diabetes Mellitus, Type 2, Chronic Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Not described | |
| Chronic Periodontitis | Not described | |
| Better Controlled T2DM | Not described | |
| Poor Controlled T2DM | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Level of Metabolic Control
Measured: One Year
Secondary outcomes (1)
Clinical Periodontal Status
Periodontal indices evaluating clinical periodontal health status
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJan 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Yener ÖZAT, Suleyman Demirel University
- Investigators
- F. Yeşim Kırzıoğlu, 1, Study director, Professor, Periodontology DeptMustafa Nazıroğlu, 1, Study director, Professor, Biophysics DeptM. Numan Tamer, 1, Study director, Professor, Internal Diseases Dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467674
- Sponsor's protocol ID
- 1721-D-08
- Status last verified
- Nov 2011
- First submitted
- 1 Nov 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malondialdehyde And Antioxidant Levels In Chronic Periodontitis Patients With Type 2 Diabetes Mellitus Under Different Stages Of Metabolic Control
- ClinicalTrials.gov ID
- NCT01467674
- Acronym / sponsor ID
- 1721-D-08
- Conditions
- Type 2 Diabetes Mellitus, Chronic Periodontitis
- Keywords
- Diabetes mellitus, Chronic periodontitis, Malondialdehyde, Glutathione peroxidase, Paraoxonase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was to investigate the impact of glycemic control on clinical periodontal status, levels of malondialdehyde (MDA), glutathione peroxidase (GSH-Px), reduced glutathione (GSH) and paraoxonase (PON) activity in gingival crevicular fluid (GCF) and blood samples of type 2 diabetes mellitus (T2DM) patients with chronic periodontitis (CP).
Detailed description
Reactive oxygen species (ROS) are products of normal cellular metabolism and play beneficial role in physiological functions. Overproduction of ROS and/or deficiency of enzymatic or non-enzymatic antioxidants, termed as oxidative stress, is involved in many pathological conditions such as Diabetes mellitus (DM) and chronic periodontitis (CP).
Several researches revealed that DM, with many determinants such as level of glycemic control, stands as a strong risk factor for periodontal diseases. On the other side, periodontal diseases induce an elevated chronic inflammatory state and exacerbated insulin resistance.
In the present study, the investigators examined the effect of glycemic control level on clinical periodontal status, levels of MDA, GSH-Px, GSH and PON activity in gingival crevicular fluid and blood samples of CP patients with T2DM.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | – |
| Chronic Periodontitis | – | – |
| Better Controlled T2DM | – | – |
| Poor Controlled T2DM | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with T2DM were recruited among those attending Suleyman Demirel University (SDU) Faculty of Medicine, Department of Endocrinology and non-diabetic individuals were recruited among those attending SDU Faculty of Dentistry, Department of Periodontology.
Key inclusion criteria (2 listed)
- to present T2DM diagnosis by an endocrinologist for at least the past 5 years
- diagnosis of CP was based on the clinical and radiographic criteria proposed by the 1999 World Workshop for Classification of Periodontal Diseases and Conditions
Key exclusion criteria (8 listed)
- pregnancy
- lactation
- current smoking or smoking within the past 2 years, periodontal therapy in the previous 6 months
- antibiotic and/or antimicrobial therapies in the previous 3 months
- existence of serious diabetic complications or any pathology such as haemoglobinopathy which would affect haemoglobin profile
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c
Time frame: One Year
Level of Metabolic Control
1 secondary outcome
Clinical Periodontal Status
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F. Yeşim Kırzıoğlu, 1 study director
Professor, Periodontology Dept
Mustafa Nazıroğlu, 1 study director
Professor, Biophysics Dept
M. Numan Tamer, 1 study director
Professor, Internal Diseases Dept.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Chronic Periodontitis, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: One Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2011; AzTrials last refreshed its copy on 8 Nov 2026.