Diabetes Mellitus RiskNCT02977598
Relations Between Atherogenic Index of Plasma-Glucose Metabolism
An observational study of Diabetes Mellitus Risk, run by Erzincan University at 2 sites in Turkey (Türkiye).
Trial summary
In this study, the investigators aimed to find out whether there is any association between the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the well-known diabetic risk factors, the investigators purposed to reveal new ones. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Risk
- Type of treatment
- Pill or oral medicine
- How many people
- 448 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- Feb 2014to Feb 2015
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 448 healthy individuals who were at risk for diabetes. According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association.
Who may be able to join
- All the participants were previously healthy, aged between 18 and 80 years, and were at risk for diabetes according to new criteria provided by the American Diabetes Association.
Who cannot join
- Individuals with a history of chronic medical diseases and those who reported current use of any medication were excluded from the study
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Erzincan Mengucekgazi Research and Training Hospital
Erzincan, 00024
Erzincan Mengücekgazi Training and Research Hospital
Erzincan, 00024
About this study
Official title: Association Between Atherogenic Index of Plasma, Blood Pressure and Impaired Glucose Metabolism
In this study, the investigators aimed to find out whether there is any association between the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the well-known diabetic risk factors, the investigators purposed to reveal new ones.
Read the detailed description
Atherogenic index of plasma (AIP) is a relatively new index and a predictor of cardiovascular risk. AIP has been shown to be associated with impaired glucose metabolism. This study aimed to evaluate the relationship between AIP and parameters of glucose metabolism.
Methods: This observational study involved 448 healthy individuals who were at risk for diabetes. They were sent to hospital for diabetes check. According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association (ADA). The association between the diabetes group, AIP and parameters of glucose metabolism was analyzed.
The accuracy of registry data compatible with medical records. Statistical analyses were carried out using the Statistical Package for Social Sciences, Windows version 15.0 (SPSS, Chicago, Illinois, USA). Descriptive statistics for each variable were determined. Normality of the data distribution was assessed with the Kolmogorov-Smirnov test. For continuous variables, non-parametric statistics (Mann-Whitney or Kruskal-Wallis), and parametric statistics (t-test, ANOVA analysis) were used as appropriate. Statistically significant differences between the groups were determined by the chi-square test for categorical variables. Associations between the variables were explored using the Pearson correlation and Spearman's rho (for data that was not normally distributed). Linear regression analysis with backward elimination was also performed to define variables associated with AIP.
- Conditions
- Diabetes Mellitus Risk
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 |
|---|---|---|
| non-diabetic | According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association. | |
| prediabetic | According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association. | |
| diabetic | According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atherogenic index of plasma (AIP) values compared with glucose metabolism parameters like HbA1c, Fasting Plasma Glucose and 2-hour plasma glucose levels.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus RiskStudies 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
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HILAL ALPCAN, Erzincan University
- Investigators
- EMIN MURAT AKBAS, Assoc. Prof., Principal investigator, ERZINCAN MENGUCEKGAZI TRAINING AND RESEARCH HOSPİTAL DEPARTMENT OF ENDOCRINOLOGY AND METABOLIC DISEASES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977598
- Sponsor's protocol ID
- 44495147/1-202
- Status last verified
- Nov 2016
- First submitted
- 20 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Atherogenic Index of Plasma, Blood Pressure and Impaired Glucose Metabolism
- ClinicalTrials.gov ID
- NCT02977598
- Acronym / sponsor ID
- 44495147/1-202
- Conditions
- Diabetes Mellitus Risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Nov 2016 (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.
In this study, the investigators aimed to find out whether there is any association between the atherogenic index of plasma with the glucose metabolism.In this respect, apart from the well-known diabetic risk factors, the investigators purposed to reveal new ones.
Detailed description
Atherogenic index of plasma (AIP) is a relatively new index and a predictor of cardiovascular risk. AIP has been shown to be associated with impaired glucose metabolism. This study aimed to evaluate the relationship between AIP and parameters of glucose metabolism.
Methods: This observational study involved 448 healthy individuals who were at risk for diabetes. They were sent to hospital for diabetes check. According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association (ADA). The association between the diabetes group, AIP and parameters of glucose metabolism was analyzed.
The accuracy of registry data compatible with medical records. Statistical analyses were carried out using the Statistical Package for Social Sciences, Windows version 15.0 (SPSS, Chicago, Illinois, USA). Descriptive statistics for each variable were determined. Normality of the data distribution was assessed with the Kolmogorov-Smirnov test. For continuous variables, non-parametric statistics (Mann-Whitney or Kruskal-Wallis), and parametric statistics (t-test, ANOVA analysis) were used as appropriate. Statistically significant differences between the groups were determined by the chi-square test for categorical variables. Associations between the variables were explored using the Pearson correlation and Spearman's rho (for data that was not normally distributed). Linear regression analysis with backward elimination was also performed to define variables associated with AIP.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non-diabetic | – | –According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association. |
| prediabetic | – | –According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association. |
| diabetic | – | –According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 448 healthy individuals who were at risk for diabetes. According to the 75 g oral glucose tolerance test participants were categorized into the three groups; non-diabetic, prediabetic, and diabetic based on the criteria of the American Diabetes Association.
Key inclusion criteria (1 listed)
- All the participants were previously healthy, aged between 18 and 80 years, and were at risk for diabetes according to new criteria provided by the American Diabetes Association.
Key exclusion criteria (1 listed)
- Individuals with a history of chronic medical diseases and those who reported current use of any medication were excluded from the study
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
Atherogenic index of plasma (AIP) values compared with glucose metabolism parameters like HbA1c, Fasting Plasma Glucose and 2-hour plasma glucose levels.
Time frame: 6 months
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 30 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus Risk
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
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.
EMIN MURAT AKBAS, Assoc. Prof. principal investigator
ERZINCAN MENGUCEKGAZI TRAINING AND RESEARCH HOSPİTAL DEPARTMENT OF ENDOCRINOLOGY AND METABOLIC DISEASES
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Risk, run by Erzincan University at 2 sites 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 1 inclusion and 1 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 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Atherogenic index of plasma (AIP) values compared with glucose metabolism parameters like HbA1c, Fasting Plasma Glucose and 2-hour plasma glucose levels. (time frame: 6 months). 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 30 Nov 2016.