Trial Outcomes & Findings for Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ) (NCT NCT01121172)

Results Overview

Apelin levels were measured in serum of participants, in fasting state

Recruitment status

COMPLETED

Target enrollment

180 participants

Primary outcome timeframe

First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning

Results posted on

2016-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Obese obese children and adolescents according to International Obesity Task Force criteria	Lean lean children and adolescents matched for age and gender to the obese group
Overall Study STARTED	90	90
Overall Study COMPLETED	90	90
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Apelin Levels and G212A Polymorphism of Apelin Receptor (APJ)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obese n=90 Participants obese children and adolescents according to International Obesity Task Force criteria	Lean n=90 Participants lean children and adolescents matched for age and gender to the obese group	Total n=180 Participants Total of all reporting groups
Age, Continuous	11.6 years n=5 Participants	11.7 years n=7 Participants	11.6 years n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	47 Participants n=7 Participants	103 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	43 Participants n=7 Participants	77 Participants n=5 Participants
Region of Enrollment Greece	90 participants n=5 Participants	90 participants n=7 Participants	180 participants n=5 Participants

PRIMARY outcome

Timeframe: First day after enrollment and after 8-hours of night fasting, at approximately 8:00 pm in the morning

Apelin levels were measured in serum of participants, in fasting state

Outcome measures

Outcome measures
Measure	Obese n=90 Participants obese children and adolescents according to International Obesity Task Force criteria	Lean n=90 Participants lean children and adolescents matched for age and gender to the obese group
Serum Apelin Levels	1.45 ng/ml Interval 0.63 to 4.54	1.91 ng/ml Interval 0.55 to 4.71

SECONDARY outcome

Timeframe: First day after enrollment

Population: Data were collected only from the Obese participants. Data regarding the genetic polymorphism were not collected from participants forming the Lean Arm/Group.

Number of participants with Apelin Receptor Gene G212A polymorphism by genotype group

Outcome measures

Outcome measures
Measure	Obese n=90 Participants obese children and adolescents according to International Obesity Task Force criteria	Lean lean children and adolescents matched for age and gender to the obese group
Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents GG	48 participants	—
Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents AA	7 participants	—
Frequency of G212A Polymorphism of Apelin Receptor in Obese Children and Adolescents GA	35 participants	—

Adverse Events

Obese

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lean

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assimina Galli-Tsinopoulou, As.Professor of Pediatric Endocrinology

4th Department of Pediatrics, School of Medicine, Aristotle University of Thessaloniki

Phone: 00302310991537

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place