Trial Outcomes & Findings for The Effect of Growth Hormone Replacement on Liver Fat (NCT NCT00774579)
NCT ID: NCT00774579
Last Updated: 2019-07-12
Results Overview
IHCL content determined by proton magnetic resonance spectroscopy (1H MRS).
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
6 months
Results posted on
2019-07-12
Participant Flow
Between April 2008 and April 2009 adult hypopituitary patients with untreated GHD were identified and recruited at the endocrine clinics of Imperial College Healthcare NHS Trust.
Participant milestones
| Measure |
GH Replacement
Patients with growth hormone (GH) deficiency starting GH replacement.
|
Control
Patients with growth hormone (GH) deficiency not starting GH replacement.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Growth Hormone Replacement on Liver Fat
Baseline characteristics by cohort
| Measure |
GH Replacement
n=9 Participants
Patients with growth hormone (GH) deficiency starting GH replacement.
|
Control
n=9 Participants
Patients with growth hormone (GH) deficiency not starting GH replacement.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 8 • n=99 Participants
|
52 years
STANDARD_DEVIATION 9 • n=107 Participants
|
52 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsIHCL content determined by proton magnetic resonance spectroscopy (1H MRS).
Outcome measures
| Measure |
GH Replacement
n=9 Participants
Patients with growth hormone (GH) deficiency starting GH replacement.
|
Control
n=9 Participants
Patients with growth hormone (GH) deficiency not starting GH replacement.
|
|---|---|---|
|
Intrahepatocellular Lipid (IHCL) Content
|
-0.63 % change from baseline
Standard Deviation 4.53
|
0.11 % change from baseline
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: 6 monthstotal adipose tissue assessed by MRI scan
Outcome measures
| Measure |
GH Replacement
n=9 Participants
Patients with growth hormone (GH) deficiency starting GH replacement.
|
Control
n=9 Participants
Patients with growth hormone (GH) deficiency not starting GH replacement.
|
|---|---|---|
|
Total Adipose Tissue
|
-1.8 kg
Standard Deviation 3.2
|
0.24 kg
Standard Deviation 2.28
|
Adverse Events
GH Replacement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Prof. Desmond Johnston
Imperial College Healthcare London
Phone: 020 3312 1253
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place