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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02977598
Other study ID # 44495147/1-202
Secondary ID
Status Completed
Phase N/A
First received November 20, 2016
Last updated November 26, 2016
Start date February 2014
Est. completion date February 2015

Study information

Verified date November 2016
Source Erzincan University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 448
Est. completion date February 2015
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Individuals with a history of chronic medical diseases and those who reported current use of any medication were excluded from the study

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Erzincan Mengucekgazi Research and Training Hospital Erzincan
Turkey Erzincan Mengücekgazi Training and Research Hospital Erzincan

Sponsors (1)

Lead Sponsor Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Atherogenic index of plasma (AIP) values compared with glucose metabolism parameters like HbA1c, Fasting Plasma Glucose and 2-hour plasma glucose levels. 6 months No
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