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| ID | Type | Description | Link |
|---|---|---|---|
| MGH GCRC 678 | |||
| 2004-P-000013 | |||
| R01HL077674 | U.S. NIH Grant/Contract | View source |
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This study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women and men. In women and men with increased abdominal weight, growth hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin resistance and body composition will be measured.
The purpose of this study is to measure growth hormone levels in women and men who are normal weight, overweight, and obese. Growth hormone levels will be correlated with body weight, body composition, and markers of cardiovascular risk. In overweight or obese women and men with increased visceral adiposity and below average IGF-1 levels, growth hormone versus placebo will be given for 6 months. Effects of growth hormone treatment on weight, body composition, insulin resistance, lipids, and cardiovascular risk markers will then be assessed. Study subjects will be followed for an additional six months for these endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male on GH | Experimental | Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. |
|
| Male on Placebo | Placebo Comparator | Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. |
|
| Female on GH | Experimental | Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. |
|
| Female on Placebo | Placebo Comparator | Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutropin AQ growth hormone | Drug | Participants will give themselves injections of growth hormone every night for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| HsCRP | 6 month change in HsCRP (primary cardiovascular risk endpoint) | Measured at baseline and month 6 |
| Total Abdominal Fat | 6 month change in total abdominal fat (primary body composition endpoint) | Measured at baseline and month 6 |
| Abdominal Fat | 6 month change in visceral abdominal fat (primary body composition endpoint) | Measured at baseline and month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Insulin Resistance | 6 month change in 2-hour glucose (primary insulin resistance endpoint) | Measured at baseline and month 6 |
| Insulin-like Growth Factor-1 (IGF-1) Levels | 6-month change in IGF-1 levels |
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Inclusion Criteria:
For growth hormone measurement part (for men and women):
For growth hormone treatment part (for men and women):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen K. Miller, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29679919 | Derived | Dichtel LE, Bjerre M, Schorr M, Bredella MA, Gerweck AV, Russell BM, Frystyk J, Miller KK. The effect of growth hormone on bioactive IGF in overweight/obese women. Growth Horm IGF Res. 2018 Jun;40:20-27. doi: 10.1016/j.ghir.2018.03.003. Epub 2018 Mar 10. | |
| 28628810 | Derived | Bredella MA, Karastergiou K, Bos SA, Gerweck AV, Torriani M, Fried SK, Miller KK. GH administration decreases subcutaneous abdominal adipocyte size in men with abdominal obesity. Growth Horm IGF Res. 2017 Aug;35:17-20. doi: 10.1016/j.ghir.2017.06.001. Epub 2017 Jun 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Female on GH | Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. |
| FG001 | Female on Placebo | Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. |
| FG002 | Male on GH | Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. |
| FG003 | Male on Placebo | Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Female on GH | Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | HsCRP | 6 month change in HsCRP (primary cardiovascular risk endpoint) | ITT | Posted | Mean | Standard Error | mg/L | Measured at baseline and month 6 |
|
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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 | Female on GH | Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | General disorders | Development of breast cancer in a subject on placebo. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Glucose Measurements | Endocrine disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen K. Miller | Massachusetts General Hospital | 617-726-3870 | kkmiller@partners.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D056128 | Obesity, Abdominal |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo Growth Hormone | Drug | Participants will give themselves injections of placebo growth hormone every night for 6 months. |
|
| Measured at baseline and month 6 |
| 26663235 | Derived | Bove RM, White CC, Gerweck AV, Mancuso SM, Bredella MA, Sherman JC, Miller KK. Effect of growth hormone on cognitive function in young women with abdominal obesity. Clin Endocrinol (Oxf). 2016 Apr;84(4):635-7. doi: 10.1111/cen.12996. Epub 2016 Feb 2. No abstract available. |
| 25210883 | Derived | Dichtel LE, Yuen KC, Bredella MA, Gerweck AV, Russell BM, Riccio AD, Gurel MH, Sluss PM, Biller BM, Miller KK. Overweight/Obese adults with pituitary disorders require lower peak growth hormone cutoff values on glucagon stimulation testing to avoid overdiagnosis of growth hormone deficiency. J Clin Endocrinol Metab. 2014 Dec;99(12):4712-9. doi: 10.1210/jc.2014-2830. |
| 24508386 | Derived | Bredella MA, Gerweck AV, Barber LA, Breggia A, Rosen CJ, Torriani M, Miller KK. Effects of growth hormone administration for 6 months on bone turnover and bone marrow fat in obese premenopausal women. Bone. 2014 May;62:29-35. doi: 10.1016/j.bone.2014.01.022. Epub 2014 Feb 5. |
| 23146135 | Derived | Lin E, Bredella MA, Gerweck AV, Landa M, Schoenfeld D, Utz AL, Miller KK. Effects of growth hormone withdrawal in obese premenopausal women. Clin Endocrinol (Oxf). 2013 Jun;78(6):914-9. doi: 10.1111/cen.12102. |
| 22275471 | Derived | Bredella MA, Lin E, Brick DJ, Gerweck AV, Harrington LM, Torriani M, Thomas BJ, Schoenfeld DA, Breggia A, Rosen CJ, Hemphill LC, Wu Z, Rifai N, Utz AL, Miller KK. Effects of GH in women with abdominal adiposity: a 6-month randomized, double-blind, placebo-controlled trial. Eur J Endocrinol. 2012 Apr;166(4):601-11. doi: 10.1530/EJE-11-1068. Epub 2012 Jan 24. |
| Female on Placebo |
Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. |
| BG002 | Male on GH | Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. |
| BG003 | Male on Placebo | Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Female on GH | Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. |
| OG003 | Female on Placebo | Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. |
|
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| Secondary | Measure of Insulin Resistance | 6 month change in 2-hour glucose (primary insulin resistance endpoint) | Posted | Mean | Standard Error | mg/dL | Measured at baseline and month 6 |
|
|
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| Secondary | Insulin-like Growth Factor-1 (IGF-1) Levels | 6-month change in IGF-1 levels | Posted | Mean | Standard Error | ng/mL | Measured at baseline and month 6 |
|
|
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| Primary | Total Abdominal Fat | 6 month change in total abdominal fat (primary body composition endpoint) | Posted | Mean | Standard Error | cm^2 | Measured at baseline and month 6 |
|
|
|
| Primary | Abdominal Fat | 6 month change in visceral abdominal fat (primary body composition endpoint) | Posted | Mean | Standard Error | cm^2 | Measured at baseline and month 6 |
|
|
|
| 0 |
| 40 |
| 4 |
| 40 |
| EG001 | Female on Placebo | Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. | 1 | 40 | 3 | 40 |
| EG002 | Male on GH | Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels. Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. | 0 | 32 | 7 | 32 |
| EG003 | Male on Placebo | Participants received placebo. Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. | 1 | 30 | 3 | 30 |
| MVA - motor vehicle accident | Injury, poisoning and procedural complications | Motor vehicle accident in a male subject on placebo. |
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| Carpel Tunnel Symptoms | Musculoskeletal and connective tissue disorders |
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| Breast Calcification on Mammogram | General disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
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| Cervical HPV | Reproductive system and breast disorders |
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| Goiter | Endocrine disorders |
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| Breast Lump | Reproductive system and breast disorders |
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| New onset atrial fibrillation | Cardiac disorders |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |