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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Obesity is associated with reduced growth hormone (GH) secretion. Reduced GH secretion in obesity is associated with increased cardiovascular disease risk. However, it is not yet known how reduced GH increases cardiovascular disease risk in obesity. The investigators hypothesize that reduced GH contributes to dysfunction of the mitochondria. Therefore, the investigators hypothesize that treatment of obese subjects with reduced GH secretion with GH will improve mitochondrial function and that this improvement in mitochondrial function will contribute, in part, to the effects of GH to improve metabolic parameters in obesity. The investigators propose to study skeletal muscle mitochondria in obese subjects with reduced GH secretion using magnetic resonance spectroscopy and muscle biopsies before and after treatment with GH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Growth Hormone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Growth hormone treatment | Drug | Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phosphocreatine Recovery | 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. | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Circulating IGF-1 Concentration | Change in circulating IGF-1 from Baseline to 12-weeks is reported. | Baseline and 12-weeks |
| Change in Skeletal Muscle IGF-1 Gene Expression | Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hideo Makimura, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Obese male subjects with reduced growth hormone secretion
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| ID | Title | Description |
|---|---|---|
| BG000 | Growth Hormone | Growth hormone treatment: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phosphocreatine Recovery | 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. | 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. | Posted | Number | correlation coefficient | 12-weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hideo Makimura, MD, PhD | Massachusetts General Hospital | 617-726-8277 | hmakimura@partners.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline and 12-weeks |
| Change in Body Composition | Change in waist circumference from Baseline to 12-weeks is reported. | Baseline and 12-weeks |
| Change in Inflammatory Marker | Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported. | Baseline and 12-weeks |
| Change in Insulin Sensitivity | Change in fasting glucose from Baseline to 12-weeks is reported. | Baseline and 12-weeks |
| Change in Phosphocreatine Recovery | Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported. | Baseline and 12-weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
|
|
|
| Secondary | Change in Circulating IGF-1 Concentration | Change in circulating IGF-1 from Baseline to 12-weeks is reported. | Posted | Mean | Standard Error | ug/l | Baseline and 12-weeks |
|
|
|
|
| Secondary | Change in Skeletal Muscle IGF-1 Gene Expression | Change in skeletal muscle IGF-1 gene mRNA expression from Baseline to 12-weeks is reported. | Paired analyses (both Baseline and 12-weeks) from only 10 subjects are available for gene expression | Posted | Mean | Standard Error | fold change | Baseline and 12-weeks |
|
|
|
|
| Secondary | Change in Body Composition | Change in waist circumference from Baseline to 12-weeks is reported. | Posted | Mean | Standard Error | cm | Baseline and 12-weeks |
|
|
|
|
| Secondary | Change in Inflammatory Marker | Change in high sensitivity C-reactive protein (hsCRP) from Baseline to 12-weeks is reported. | Posted | Mean | Standard Error | mg/l | Baseline and 12-weeks |
|
|
|
|
| Secondary | Change in Insulin Sensitivity | Change in fasting glucose from Baseline to 12-weeks is reported. | Posted | Mean | Standard Error | mg/dl | Baseline and 12-weeks |
|
|
|
|
| Secondary | Change in Phosphocreatine Recovery | Change in phosphocreatine recovery, represented by ViPCr, from Baseline to 12-weeks is reported. | 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. | Posted | Mean | Standard Error | mM/min | Baseline and 12-weeks |
|
|
|
|
| 0 |
| 15 |
| 11 |
| 15 |
| Carpal tunnel syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Head ache | Nervous system disorders | Systematic Assessment |
|
| Hypersensitivity reaction | Immune system disorders | Systematic Assessment |
|
| Injection site bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Injection site bruising | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Injection site pain, pruritis, erythema, induration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Myalgias | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Paresthesias | Nervous system disorders | Systematic Assessment |
|
| Peripheral edema | Cardiac disorders | Systematic Assessment |
|
| Diabetes | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |