Trial Outcomes & Findings for Endothelial Dysfunction in Obese Children (NCT NCT01461226)

Results Overview

Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

61 participants

Primary outcome timeframe

Baseline - 5 months - 10 months

Results posted on

2023-05-15

Participant Flow

Participant milestones

Participant milestones
Measure	Exercise Training Exercise training: Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance	Usual Care Usual care: Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
Overall Study STARTED	33	28
Overall Study COMPLETED	27	21
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Training n=33 Participants Exercise training: Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance	Usual Care n=28 Participants Usual care: Nutritional assessment and dietary advice by general practitioner, promotion of sports activities	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	33 Participants n=33 Participants	28 Participants n=28 Participants	61 Participants n=61 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=33 Participants	0 Participants n=28 Participants	0 Participants n=61 Participants
Age, Categorical >=65 years	0 Participants n=33 Participants	0 Participants n=28 Participants	0 Participants n=61 Participants
Age, Continuous	15 years STANDARD_DEVIATION 1.5 • n=33 Participants	15 years STANDARD_DEVIATION 1.2 • n=28 Participants	15 years STANDARD_DEVIATION 1.3 • n=61 Participants
Sex: Female, Male Female	24 Participants n=33 Participants	22 Participants n=28 Participants	46 Participants n=61 Participants
Sex: Female, Male Male	9 Participants n=33 Participants	6 Participants n=28 Participants	15 Participants n=61 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	36.44 kg/m² STANDARD_DEVIATION 4.82 • n=33 Participants	36.72 kg/m² STANDARD_DEVIATION 5.83 • n=28 Participants	36.58 kg/m² STANDARD_DEVIATION 5.33 • n=61 Participants

PRIMARY outcome

Timeframe: Baseline - 5 months - 10 months

Population: this was an intention to treat analysis. Some participants ended the treatment.

Reactive Hyperemia Index as assessed using endoPAT (R) is used as a marker for endothelial function

Outcome measures

Outcome measures
Measure	Exercise Training n=33 Participants Exercise training: Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance	Usual Care n=28 Participants Usual care: Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months 10 months	1.9 arbitrary units Interval 1.5 to 3.0	1.5 arbitrary units Interval 1.3 to 1.7
Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months 5 months	2.01 arbitrary units Interval 1.58 to 2.5	1.55 arbitrary units Interval 1.4 to 2.19
Change From Baseline in Reactive Hyperemia Index at 5 and 10 Months baseline	1.48 arbitrary units Interval 1.26 to 2.01	1.42 arbitrary units Interval 1.24 to 1.84

SECONDARY outcome

Timeframe: Baseline - 5 months - 10 months

Population: this an intention to treat analysis. Some participants ended the treatment

Exercise capacity will be assessed using bicycle ergometry at baseline and at 5 and 10 Months

Outcome measures

Outcome measures
Measure	Exercise Training n=33 Participants Exercise training: Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance	Usual Care n=28 Participants Usual care: Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
Change From Baseline in Exercise Capacity at 5 and 10 Months baseline	150 watt Interval 130.0 to 170.0	150 watt Interval 130.0 to 170.0
Change From Baseline in Exercise Capacity at 5 and 10 Months 5 months	170 watt Interval 130.0 to 210.0	150 watt Interval 130.0 to 170.0
Change From Baseline in Exercise Capacity at 5 and 10 Months 10 months	170 watt Interval 150.0 to 210.0	130 watt Interval 130.0 to 170.0

SECONDARY outcome

Timeframe: Baseline - 5 months - 10 months

Population: this is an intention to treat analysis. Some participants ended treatment

Weight and Length will be assessed to calculate Body Mass Index(BMI) at baseline and after 5 and 10 months

Outcome measures

Outcome measures
Measure	Exercise Training n=33 Participants Exercise training: Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance	Usual Care n=28 Participants Usual care: Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months baseline	36.44 kg/m² Standard Deviation 4.82	36.72 kg/m² Standard Deviation 5.83
Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months 5 months	30.07 kg/m² Standard Deviation 3.85	38.40 kg/m² Standard Deviation 5.62
Change From Baseline in Body Mass Index and Body Composition at 5 and 10 Months 10 months	27.39 kg/m² Standard Deviation 3.57	39.10 kg/m² Standard Deviation 5.26

Adverse Events

Exercise Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

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

dr. Luc bruyndonckx

University of Antwerp/Antwerp University Hospital

Phone: 003238213000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place