Trial Outcomes & Findings for Circadian Brown Adipose Tissue Metabolism (NCT NCT02285270)
NCT ID: NCT02285270
Last Updated: 2016-12-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
~12-hours
Results posted on
2016-12-07
Participant Flow
Participant milestones
| Measure |
Single Group Assignment
Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Single Group Assignment
Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Determined to be ineligible
|
1
|
Baseline Characteristics
Circadian Brown Adipose Tissue Metabolism
Baseline characteristics by cohort
| Measure |
Single Group Assignment
n=10 Participants
Diagnostic test/procedure - FDG PET/CT
FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Gender
Female
|
0 Participants
n=5 Participants
|
|
Gender
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ~12-hoursPopulation: No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: ~12-hoursPopulation: No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: ~12-hoursPopulation: No patients were analyzed since no patient showed uptake of FDG in brown adipose tissue.
Outcome measures
Outcome data not reported
Adverse Events
Single Group Assignment
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place