Trial Outcomes & Findings for Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism (NCT NCT02411461)
NCT ID: NCT02411461
Last Updated: 2019-11-13
Results Overview
Intelligence quotient as measured by Kaufman Brief Intelligence Test, 2nd Edition. This scale yields standard scores where the mean is 100 and one standard deviation is 15. Higher scores indicate better function.
Recruitment status
COMPLETED
Target enrollment
39 participants
Primary outcome timeframe
one day
Results posted on
2019-11-13
Participant Flow
Participant milestones
| Measure |
Pseudohypoparathyroidism Type 1a
Study group
|
Healthy Siblings
Control group
|
Obese Patients
Control group
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
15
|
|
Overall Study
COMPLETED
|
16
|
8
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early-onset Obesity and Cognitive Impairment in Children With Pseudohypoparathyroidism
Baseline characteristics by cohort
| Measure |
Pseudohypoparathyroidism Type 1a
n=16 Participants
Study group
|
Healthy Siblings
n=8 Participants
Control group
|
Obese Patients
n=15 Participants
Control group
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
26 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: one dayIntelligence quotient as measured by Kaufman Brief Intelligence Test, 2nd Edition. This scale yields standard scores where the mean is 100 and one standard deviation is 15. Higher scores indicate better function.
Outcome measures
| Measure |
Pseudohypoparathyroidism Type 1a
n=16 Participants
Study group
|
Healthy Siblings
n=8 Participants
Control group
|
Obese Patients
n=15 Participants
Control group
|
|---|---|---|---|
|
Intelligence Quotient
|
85.9 units on a scale
Standard Deviation 17.2
|
104.3 units on a scale
Standard Deviation 8.9
|
103.2 units on a scale
Standard Deviation 11.5
|
Adverse Events
Pseudohypoparathyroidism Type 1a
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Siblings
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese Patients
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
Ashley Shoemaker, Principal Investigator
Vanderbilt University Medical Center
Phone: 6153438116
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place