Trial Outcomes & Findings for Down Syndrome Metabolic Health Study (NCT NCT01821300)
NCT ID: NCT01821300
Last Updated: 2019-07-31
Results Overview
Non-HDL cholesterol measured via fasting blood draw
Recruitment status
COMPLETED
Target enrollment
257 participants
Primary outcome timeframe
Study Visit 1
Results posted on
2019-07-31
Participant Flow
Participant milestones
| Measure |
Down Syndrome
154 participants ages 10-20 years old.
No intervention occurred as this is a cross-sectional observational study.
|
Control
103 age-, sex-, race-, ethnicity-, and BMI percentile-matched control subjects.
No intervention occurred as this is a cross-sectional observational study.
|
|---|---|---|
|
Overall Study
STARTED
|
154
|
103
|
|
Overall Study
COMPLETED
|
154
|
103
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Down Syndrome Metabolic Health Study
Baseline characteristics by cohort
| Measure |
Down Syndrome
n=154 Participants
Our goal is to enroll 155 subjects with Down syndrome, and to compare their data to our control group.
|
Control
n=103 Participants
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.4 years
STANDARD_DEVIATION 0.3 • n=93 Participants
|
14.7 years
STANDARD_DEVIATION 0.3 • n=4 Participants
|
14.7 years
STANDARD_DEVIATION 0.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=93 Participants
|
61 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
109 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
141 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
238 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
117 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
191 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
154 participants
n=93 Participants
|
103 participants
n=4 Participants
|
257 participants
n=27 Participants
|
|
BMI Percentile
|
81.4 percentile
STANDARD_DEVIATION 1.8 • n=93 Participants
|
79.3 percentile
STANDARD_DEVIATION 2.5 • n=4 Participants
|
80.5 percentile
STANDARD_DEVIATION 1.4 • n=27 Participants
|
PRIMARY outcome
Timeframe: Study Visit 1Population: Participants excluded from lipid analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=7, Controls=0
Non-HDL cholesterol measured via fasting blood draw
Outcome measures
| Measure |
Down Syndrome
n=147 Participants
Down syndrome participants in observational study.
|
Control
n=103 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Non-HDL Cholesterol
|
128 mg/dl
Interval 104.0 to 153.0
|
107 mg/dl
Interval 92.0 to 123.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Visit 1Population: Participants excluded from lipid analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=7, Controls=0.
Lipoprotein subclass particle analysis run on samples from fasting blood drawn Study Visit 1.
Outcome measures
| Measure |
Down Syndrome
n=147 Participants
Down syndrome participants in observational study.
|
Control
n=103 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Lipid Subparticles
Small LDL-P (nmol/L)
|
518 nmol/L
Interval 401.0 to 639.0
|
420 nmol/L
Interval 315.0 to 529.0
|
—
|
—
|
|
Lipid Subparticles
Total LDL-P (nmol/L)
|
977 nmol/L
Interval 806.0 to 1193.0
|
850 nmol/L
Interval 693.0 to 997.0
|
—
|
—
|
|
Lipid Subparticles
Small HDL-P (nmol/L)
|
9.8 nmol/L
Interval 5.3 to 14.0
|
11.7 nmol/L
Interval 8.9 to 14.9
|
—
|
—
|
|
Lipid Subparticles
Large VLDL-P (nmol/L)
|
3.9 nmol/L
Interval 2.3 to 5.7
|
2.4 nmol/L
Interval 1.5 to 4.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Visit 1Population: Participants excluded from lipid analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=7, Controls=0.
Lipoprotein subclass particle analysis run on samples from fasting blood drawn Study Visit 1.
Outcome measures
| Measure |
Down Syndrome
n=147 Participants
Down syndrome participants in observational study.
|
Control
n=103 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Lipid Subparticles (Size)
HDL-P size (nm)
|
9.6 nm
Interval 9.2 to 9.9
|
9.6 nm
Interval 9.1 to 9.9
|
—
|
—
|
|
Lipid Subparticles (Size)
VLDL-P size (nm)
|
49.2 nm
Interval 45.8 to 53.6
|
47.1 nm
Interval 44.2 to 50.7
|
—
|
—
|
|
Lipid Subparticles (Size)
LDL-P size (nm)
|
20.7 nm
Interval 20.3 to 21.2
|
20.7 nm
Interval 20.2 to 21.1
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Visit 1Population: Participants excluded from insulin resistance analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=147, Controls=103.
Insulin Resistance (HOMA-IR) was calculated as \[fasting insulin (uIU/mL) x fasting glycemia (mmol/L)\]/22.5
Outcome measures
| Measure |
Down Syndrome
n=147 Participants
Down syndrome participants in observational study.
|
Control
n=103 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Insulin Resistance
|
1.8 HOMA-IR
Interval 1.0 to 2.7
|
1.95 HOMA-IR
Interval 0.92 to 3.4
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Visit 1Population: Participants excluded from analysis if they failed to complete blood draw or were diagnosed with Type 1 Diabetes: DS=7, Controls=0.
hs-CRP, PAI-1, and IL-6 run on samples from fasting blood drawn Study Visit 1.
Outcome measures
| Measure |
Down Syndrome
n=147 Participants
Down syndrome participants in observational study.
|
Control
n=103 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Cardiometabolic Risk Biomarker Proteins
IL-6
|
2.3 ng/dL
Interval 1.4 to 3.5
|
1.5 ng/dL
Interval 1.4 to 2.9
|
—
|
—
|
|
Cardiometabolic Risk Biomarker Proteins
PAI-1
|
0.0204 ng/dL
Interval 0.0132 to 0.0327
|
0.0254 ng/dL
Interval 0.0147 to 0.0385
|
—
|
—
|
|
Cardiometabolic Risk Biomarker Proteins
hs-CRP
|
2.5 ng/dL
Interval 0.64 to 6.9
|
1.0 ng/dL
Interval 0.32 to 4.5
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Visit 1Population: Participants completed an oral glucose tolerance test if they were in the overweight or obese categories: DS n=96, Control n=64.
Impaired fasting glucose (IFG) was defined as fasting glucose ≥ 100 mg/dl. Impaired glucose tolerance (IGT) was defined as 2-hour glucose 140-199 mg/dl measured as part of an oral glucose tolerance test.
Outcome measures
| Measure |
Down Syndrome
n=96 Participants
Down syndrome participants in observational study.
|
Control
n=64 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Abnormal Glucose Tolerance
Impaired Fasting Glucose
|
12 Participants
|
3 Participants
|
—
|
—
|
|
Abnormal Glucose Tolerance
Abnormal Glucose Tolerance
|
10 Participants
|
3 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Visit 1Adiposity measured by Dual-energy X-ray absorptiometry
Outcome measures
| Measure |
Down Syndrome
n=154 Participants
Down syndrome participants in observational study.
|
Control
n=103 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Visceral Fat
|
54.5 cm^2
Interval 39.9 to 81.9
|
55.9 cm^2
Interval 40.6 to 95.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Visit 1Adiposity measured by Dual-energy X-ray absorptiometry
Outcome measures
| Measure |
Down Syndrome
n=154 Participants
Down syndrome participants in observational study.
|
Control
n=103 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Body Mass Measures
Whole Body Fat Mass
|
18607.5 g
Interval 12034.8 to 27557.7
|
22372.1 g
Interval 16143.0 to 39723.8
|
—
|
—
|
|
Body Mass Measures
Whole Body Lean Mass
|
34927.16 g
Interval 27527.39 to 42383.86
|
44108.3 g
Interval 32439.9 to 52181.3
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Visit 1Population: LVM was available in 136 adolescents with DS (60M/76F) and 101nonDS controls (41M/60F).
Cardiac end organ injury assessed by echocardiography. Left Ventricular Mass (LVM) was measured by area/length method using the apical four-chamber and parasternal short-axis views. LVM was calculated as LV area × LV length × 1.05 × 5/6.
Outcome measures
| Measure |
Down Syndrome
n=136 Participants
Down syndrome participants in observational study.
|
Control
n=101 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Left Ventricular Mass
|
68.3 g
Interval 32.1 to 135.0
|
64 g
Interval 53.0 to 77.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Study Visit 1Population: PWV was available in 129 adolescents with DS and 97 controls
Cardiac end organ injury assessed by Pulse Wave Velocity (PWV)
Outcome measures
| Measure |
Down Syndrome
n=129 Participants
Down syndrome participants in observational study.
|
Control
n=97 Participants
Control participants in observational study.
|
Control, Obese
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Pulse Wave Velocity
|
5 m/s
Interval 4.5 to 5.6
|
4.9 m/s
Interval 4.5 to 5.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Study Visit 1Caregiver-perception of his/her child's health-related QOL was assessed with the use of the parent-proxy report of the Pediatric Quality of Life Inventory (PedsQL) Version 4.0. Sub-scale scores are converted to a 0-100 scale so that greater scores indicate better QOL. Scale scores are computed as the sum of the items divided by the number of items answered (this accounts for missing data). If more than 50% of the items in the scale are missing, the scale score is not computed. The Physical Health Summary Score (8 items) is the same as the Physical Functioning Scale. To create the Psychosocial Health Summary Score (15 items), the mean is computed as the sum of the items divided by the number of items answered in the Emotional, Social, and School Functioning Scales.
Outcome measures
| Measure |
Down Syndrome
n=63 Participants
Down syndrome participants in observational study.
|
Control
n=87 Participants
Control participants in observational study.
|
Control, Obese
n=24 Participants
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
n=34 Participants
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Health Related Quality of Life - PedsQL
Social (PedsQL)
|
60.7 score on a scale
Standard Deviation 20.9
|
63.3 score on a scale
Standard Deviation 19.2
|
80.4 score on a scale
Standard Deviation 16.4
|
85.0 score on a scale
Standard Deviation 22.3
|
|
Health Related Quality of Life - PedsQL
School (PedsQL)
|
65.1 score on a scale
Standard Deviation 18.2
|
64.0 score on a scale
Standard Deviation 17.2
|
75.6 score on a scale
Standard Deviation 18.5
|
80.0 score on a scale
Standard Deviation 24.0
|
|
Health Related Quality of Life - PedsQL
Psychosocial (PedsQL)
|
65.1 score on a scale
Standard Deviation 14.3
|
67.8 score on a scale
Standard Deviation 13.8
|
77.2 score on a scale
Standard Deviation 15.4
|
80.7 score on a scale
Standard Deviation 22.4
|
|
Health Related Quality of Life - PedsQL
Emotional (PedsQL)
|
73.3 score on a scale
Standard Deviation 76.0
|
76.0 score on a scale
Standard Deviation 14.9
|
75.6 score on a scale
Standard Deviation 19.5
|
77.2 score on a scale
Standard Deviation 25.1
|
|
Health Related Quality of Life - PedsQL
Total Score (PedsQL)
|
66.2 score on a scale
Standard Deviation 13.2
|
69.6 score on a scale
Standard Deviation 14.2
|
77.8 score on a scale
Standard Deviation 14.0
|
83.9 score on a scale
Standard Deviation 21.0
|
|
Health Related Quality of Life - PedsQL
Physical Functioning (PedsQL)
|
68.3 score on a scale
Standard Deviation 18.5
|
73.2 score on a scale
Standard Deviation 21.4
|
78.9 score on a scale
Standard Deviation 18.8
|
89.7 score on a scale
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Study Visit 1Parent perception of the effects of weight on his/her child's QOL was assessed with a caregiver-proxy version of the Impact of Weight on Quality of Life - Kids (IWQOL-Kids) questionnaire. The IWQOL-Kids is a validated, 27-item, self-report measure of weight-related QOL for youth ages 11-19 years. It yields 4 subscales (Physical Comfort, Body Esteem, Social Life, and Family Relations) and a Total score, which have strong psychometric properties, discriminate among weight status groups, and are responsive to weight change. Scaled scores are standardized and range from 0 to 100, with greater scores representing better weight-related QOL.
Outcome measures
| Measure |
Down Syndrome
n=63 Participants
Down syndrome participants in observational study.
|
Control
n=87 Participants
Control participants in observational study.
|
Control, Obese
n=24 Participants
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
Control, Not Obese
n=34 Participants
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
For the Psychosocial risk factors secondary analysis Down Syndrome and Control Groups were further divided into Obese and Not Obese sub groups for analysis.
|
|---|---|---|---|---|
|
Health Related Quality of Life - IWQOL
Physical Comfort (IWQOL-Kids)
|
83.3 score on a scale
Standard Deviation 18.6
|
97.1 score on a scale
Standard Deviation 7.5
|
86.0 score on a scale
Standard Deviation 16.6
|
98.2 score on a scale
Standard Deviation 7.9
|
|
Health Related Quality of Life - IWQOL
Family Relationships (IWQOL-Kids)
|
93.8 score on a scale
Standard Deviation 13.5
|
98.6 score on a scale
Standard Deviation 5.3
|
93.2 score on a scale
Standard Deviation 11.2
|
97.5 score on a scale
Standard Deviation 8.9
|
|
Health Related Quality of Life - IWQOL
Total (IWQOL-Kids)
|
89.8 score on a scale
Standard Deviation 11.7
|
98.0 score on a scale
Standard Deviation 5.1
|
82.4 score on a scale
Standard Deviation 16.7
|
95.9 score on a scale
Standard Deviation 10.5
|
|
Health Related Quality of Life - IWQOL
Body Esteem (IWQOL-Kids)
|
91.4 score on a scale
Standard Deviation 11.1
|
98.0 score on a scale
Standard Deviation 5.4
|
73.9 score on a scale
Standard Deviation 25.7
|
93.9 score on a scale
Standard Deviation 12.8
|
|
Health Related Quality of Life - IWQOL
Social Life (IWQOL-Kids)
|
89.7 score on a scale
Standard Deviation 17.6
|
98.4 score on a scale
Standard Deviation 5.9
|
80.7 score on a scale
Standard Deviation 21.0
|
95.0 score on a scale
Standard Deviation 14.0
|
Adverse Events
Down Syndrome
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Down Syndrome
n=154 participants at risk
Our goal is to enroll 155 subjects with Down syndrome, and to compare their data to our control group.
|
Control
n=103 participants at risk
Our goal is to enroll 105 typically developing controls, who are matched to the Down syndrome group by age, sex, race, ethnicity, and BMI-z score.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
3.2%
5/154 • Number of events 5 • Adverse Events are monitored throughout participants' roughly 6 hour study visit, and for the 2 weeks following study visit while participants are wearing accelerator armbands and completing dietary recalls at home.
|
1.9%
2/103 • Number of events 2 • Adverse Events are monitored throughout participants' roughly 6 hour study visit, and for the 2 weeks following study visit while participants are wearing accelerator armbands and completing dietary recalls at home.
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
1/154 • Number of events 1 • Adverse Events are monitored throughout participants' roughly 6 hour study visit, and for the 2 weeks following study visit while participants are wearing accelerator armbands and completing dietary recalls at home.
|
0.00%
0/103 • Adverse Events are monitored throughout participants' roughly 6 hour study visit, and for the 2 weeks following study visit while participants are wearing accelerator armbands and completing dietary recalls at home.
|
|
General disorders
Fainting
|
0.00%
0/154 • Adverse Events are monitored throughout participants' roughly 6 hour study visit, and for the 2 weeks following study visit while participants are wearing accelerator armbands and completing dietary recalls at home.
|
0.97%
1/103 • Number of events 1 • Adverse Events are monitored throughout participants' roughly 6 hour study visit, and for the 2 weeks following study visit while participants are wearing accelerator armbands and completing dietary recalls at home.
|
|
Endocrine disorders
Hypoglycemia
|
0.65%
1/154 • Number of events 1 • Adverse Events are monitored throughout participants' roughly 6 hour study visit, and for the 2 weeks following study visit while participants are wearing accelerator armbands and completing dietary recalls at home.
|
0.00%
0/103 • Adverse Events are monitored throughout participants' roughly 6 hour study visit, and for the 2 weeks following study visit while participants are wearing accelerator armbands and completing dietary recalls at home.
|
Additional Information
Dr. Andrea Kelly
The Children's Hopsital of Philadelphia
Phone: 215590-3174
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place