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Trial Outcomes & Findings for Growth Hormone Treatment on Phosphocreatine Recovery in Obesity (NCT NCT01421589)

NCT ID: NCT01421589

Last Updated: 2014-07-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

12-weeks

Results posted on

2014-07-01

Participant Flow

Participant milestones

Participant milestones
Measure
Growth Hormone Treatment
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Overall Study
STARTED
15
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Growth Hormone Treatment on Phosphocreatine Recovery in Obesity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Growth Hormone
n=15 Participants
Growth hormone treatment: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Age, Continuous
47.9 years
STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
15 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 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
4 Participants
n=5 Participants
Race (NIH/OMB)
White
10 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
15 participants
n=5 Participants

PRIMARY outcome

Timeframe: 12-weeks

Population: 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.

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.

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=10 Participants
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Phosphocreatine Recovery
0.74 correlation coefficient
5.4

SECONDARY outcome

Timeframe: Baseline and 12-weeks

Change in circulating IGF-1 from Baseline to 12-weeks is reported.

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=15 Participants
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Change in Circulating IGF-1 Concentration
218 ug/l
Standard Error 29

SECONDARY outcome

Timeframe: Baseline and 12-weeks

Population: Paired analyses (both Baseline and 12-weeks) from only 10 subjects are available for gene expression

Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported.

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=10 Participants
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Change in Skeletal Muscle IGF-1 Gene Expression
2.1 fold change
Standard Error 0.3

SECONDARY outcome

Timeframe: Baseline and 12-weeks

Change in waist circumference from Baseline to 12-weeks is reported.

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=15 Participants
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Change in Body Composition
-3 cm
Standard Error 1

SECONDARY outcome

Timeframe: Baseline and 12-weeks

Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported.

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=15 Participants
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Change in Inflammatory Marker
-1.78 mg/l
Standard Error 0.57

SECONDARY outcome

Timeframe: Baseline and 12-weeks

Change in fasting glucose from Baseline to 12-weeks is reported.

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=15 Participants
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Change in Insulin Sensitivity
6 mg/dl
Standard Error 3

SECONDARY outcome

Timeframe: Baseline and 12-weeks

Population: 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.

Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported.

Outcome measures

Outcome measures
Measure
Growth Hormone Treatment
n=13 Participants
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Change in Phosphocreatine Recovery
-10.2 mM/min
Standard Error 7.5

Adverse Events

Growth Hormone Treatment

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Growth Hormone Treatment
n=15 participants at risk
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
Musculoskeletal and connective tissue disorders
Arthralgia
26.7%
4/15 • 12 weeks
Musculoskeletal and connective tissue disorders
Carpal tunnel syndrome
0.00%
0/15 • 12 weeks
Nervous system disorders
Head ache
13.3%
2/15 • 12 weeks
Immune system disorders
Hypersensitivity reaction
0.00%
0/15 • 12 weeks
Skin and subcutaneous tissue disorders
Injection site bleeding
6.7%
1/15 • 12 weeks
Skin and subcutaneous tissue disorders
Injection site bruising
33.3%
5/15 • 12 weeks
Skin and subcutaneous tissue disorders
Injection site pain, pruritis, erythema, induration
0.00%
0/15 • 12 weeks
Musculoskeletal and connective tissue disorders
Myalgias
33.3%
5/15 • 12 weeks
Nervous system disorders
Paresthesias
6.7%
1/15 • 12 weeks
Cardiac disorders
Peripheral edema
26.7%
4/15 • 12 weeks
Metabolism and nutrition disorders
Diabetes
0.00%
0/15 • 12 weeks

Additional Information

Hideo Makimura, MD, PhD

Massachusetts General Hospital

Phone: 617-726-8277

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60