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Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

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ClinicalTrials.gov Identifier: NCT01421589
Recruitment Status : Completed
First Posted : August 23, 2011
Results First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Hideo Makimura, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Obese
Growth Hormone Secretion Abnormality
Intervention Drug: Growth hormone treatment
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Growth Hormone Treatment
Hide Arm/Group Description Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Growth Hormone
Hide Arm/Group Description Growth hormone treatment: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
Obese male subjects with reduced growth hormone secretion
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
47.9  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
0
   0.0%
Male
15
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  26.7%
White
10
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
   6.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
1
   6.7%
Not Hispanic or Latino
14
  93.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
Title Phosphocreatine Recovery
Hide Description The primary objective of this study is to determine the effects of growth hormone on mitochondrial function as assessed by 31P-MRS in obese subjects with reduced GH secretion. Mitochondrial function was represented by ViPCr, a measure of phosphocreatine recovery after sub-maximal exercise. Univariate regression analyses was performed to assess the relationship between the change in skeletal muscle IGF-1 mRNA after 12 weeks treatment with rhGH to change in ViPCr.
Time Frame 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties. In addition, paired analyses (both Baseline and 12-weeks) from only 10 subjects were available for gene expression analyses. Therefore univariate regression analyses between IGF-1 mRNA and PCr recovery could only be performed in 10 subjects.
Arm/Group Title Growth Hormone Treatment
Hide Arm/Group Description:
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: correlation coefficient
0.74
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone Treatment
Comments Univariate regression analyses was performed to assess the relationship between change in skeletal muscle IGF-1 mRNA expression after 12 weeks treatment with rhGH and change in ViPCr.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
2.Secondary Outcome
Title Change in Circulating IGF-1 Concentration
Hide Description Change in circulating IGF-1 from Baseline to 12-weeks is reported.
Time Frame Baseline and 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Treatment
Hide Arm/Group Description:
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Error)
Unit of Measure: ug/l
218  (29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Change in Skeletal Muscle IGF-1 Gene Expression
Hide Description Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.
Time Frame Baseline and 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Paired analyses (both Baseline and 12-weeks) from only 10 subjects are available for gene expression
Arm/Group Title Growth Hormone Treatment
Hide Arm/Group Description:
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Overall Number of Participants Analyzed 10
Mean (Standard Error)
Unit of Measure: fold change
2.1  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Change in Body Composition
Hide Description Change in waist circumference from Baseline to 12-weeks is reported.
Time Frame Baseline and 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Treatment
Hide Arm/Group Description:
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Error)
Unit of Measure: cm
-3  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Change in Inflammatory Marker
Hide Description Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.
Time Frame Baseline and 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Treatment
Hide Arm/Group Description:
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Error)
Unit of Measure: mg/l
-1.78  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Change in Insulin Sensitivity
Hide Description Change in fasting glucose from Baseline to 12-weeks is reported.
Time Frame Baseline and 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Growth Hormone Treatment
Hide Arm/Group Description:
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Overall Number of Participants Analyzed 15
Mean (Standard Error)
Unit of Measure: mg/dl
6  (3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Change in Phosphocreatine Recovery
Hide Description Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.
Time Frame Baseline and 12-weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Obese men with reduced GH secretion were treated with rhGH for 12 weeks. All 15 subjects underwent 31P-MRS, however, two scans were not evaluable due to technical difficulties.
Arm/Group Title Growth Hormone
Hide Arm/Group Description:
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Error)
Unit of Measure: mM/min
-10.2  (7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Growth Hormone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Growth Hormone Treatment
Hide Arm/Group Description Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
All-Cause Mortality
Growth Hormone Treatment
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Growth Hormone Treatment
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Growth Hormone Treatment
Affected / at Risk (%)
Total   11/15 (73.33%) 
Cardiac disorders   
Peripheral edema   4/15 (26.67%) 
Immune system disorders   
Hypersensitivity reaction   0/15 (0.00%) 
Metabolism and nutrition disorders   
Diabetes   0/15 (0.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia   4/15 (26.67%) 
Carpal tunnel syndrome   0/15 (0.00%) 
Myalgias   5/15 (33.33%) 
Nervous system disorders   
Head ache   2/15 (13.33%) 
Paresthesias   1/15 (6.67%) 
Skin and subcutaneous tissue disorders   
Injection site bleeding   1/15 (6.67%) 
Injection site bruising   5/15 (33.33%) 
Injection site pain, pruritis, erythema, induration   0/15 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Hideo Makimura, MD, PhD
Organization: Massachusetts General Hospital
Phone: 617-726-8277
Responsible Party: Hideo Makimura, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01421589     History of Changes
Other Study ID Numbers: 2011-P-000770
First Submitted: August 19, 2011
First Posted: August 23, 2011
Results First Submitted: March 31, 2014
Results First Posted: July 1, 2014
Last Update Posted: July 1, 2014