NCT02977598

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

November 20, 2016

Last Update Submit

November 26, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Atherogenic index of plasma (AIP) values compared with glucose metabolism parameters like HbA1c, Fasting Plasma Glucose and 2-hour plasma glucose levels.

    6 months

Study Arms (3)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erzincan Mengucekgazi Research and Training Hospital

Erzincan, 00024, Turkey (Türkiye)

Location

Erzincan Mengücekgazi Training and Research Hospital

Erzincan, 00024, Turkey (Türkiye)

Location

Study Officials

  • EMIN MURAT AKBAS, Assoc. Prof.

    ERZINCAN MENGUCEKGAZI TRAINING AND RESEARCH HOSPİTAL DEPARTMENT OF ENDOCRINOLOGY AND METABOLIC DISEASES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal medicine, medical doctor

Study Record Dates

First Submitted

November 20, 2016

First Posted

November 30, 2016

Study Start

February 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

November 30, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations