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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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Teenagers and adults who are overweight or obese have an increase in fat in the abdomen, which increases their risk for diabetes and heart disease. Reducing abdominal fat is important to reduce risk for diabetes and for heart disease. Overweight teenagers also have low levels of growth hormone compared to normal weight teenagers, and teenagers with the lowest growth hormone levels also have the greatest abdominal fat. In children who are unable to make growth hormone for other reasons, giving back growth hormone leads to a decrease in abdominal fat. We are studying whether giving growth hormone in small doses to overweight teenagers can change body composition. We hypothesize that growth hormone will cause abdominal fat to decrease and reduce the risk markers for diabetes and heart disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recombinant human growth hormone | Experimental | Forty subjects will be randomized to receive either recombinant human growth hormone or placebo. |
|
| Placebo | Placebo Comparator | Forty subjects will be randomized to receive either recombinant human growth hormone or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human growth hormone (rhGH) | Drug | Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months | Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI) | Baseline and 6 months |
| Changes in Lipid Panel | Lipid profile will be obtained using established methods. Total Cholesterol, Triglycerides, LDL and HDL measurements will be obtained at baseline, and then at the six-month visits to determine the rate at which lipid measures change with rhGH therapy | Baseline and 6 months |
| Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months | As a marker of cardiovascular risk, hs-CRP will be assessed at baseline and 6 months to assess the rate at which hs-CRP levels change with rhGH therapy. | Baseline and 6 months |
| Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months | Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score | Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. A 2-hour Oral Glucose Tolerance Test (OGTT) using 1.75 gram/kilogram of oral glucose (maximum 75 gram) will be performed at baseline and six months after administration of rhGH/placebo/ no therapy. Fasting insulin and glucose will be used to determine HOMA-IR: [fasting glucose (mmol/l) x fasting insulin (µU/ml)]/22.5] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhusmita Misra, 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 |
|---|---|---|---|
| 25435886 | Derived | Slattery M, Bredella MA, Stanley T, Torriani M, Misra M. Effects of recombinant human growth hormone (rhGH) administration on body composition and cardiovascular risk factors in obese adolescent girls. Int J Pediatr Endocrinol. 2014;2014(1):22. doi: 10.1186/1687-9856-2014-22. Epub 2014 Nov 15. | |
| 24251951 | Derived |
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Of the 32 subjects who were screened, 22 were eligible & randomized. 5 subjects were ineligible due to Insulin Like Growth Factor levels above the eligibility limit for pubertal stage or age. 2 were excluded due to planned initiation of medications that were on the exclusion criteria list and 3 voluntarily withdrew consent prior to randomization.
Participants were recruited at Massachusetts General Hospital between September 2010 and October 2012 through area pediatric and obesity clinics and advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Recombinant Human Growth Hormone | Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment. recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks. |
| FG001 | Placebo/no Treatment | Forty subjects will be randomized to receive either recombinant human growth hormone or placebo. Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Recombinant Human Growth Hormone | Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment. recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks. |
| 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 | Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months | Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI) | Due to scheduling difficulties one no treatment subject did not perform the MRI portion of the study at either the baseline or the 6 month visit. | Posted | Mean | Standard Deviation | mm^2 | Baseline and 6 months |
|
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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 | Recombinant Human Growth Hormone | Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment. recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impaired Glucose Tolerance | Endocrine disorders | Systematic Assessment | Impaired Glucose Tolerance (IGT) on 75 Gram 2 Hour Oral Glucose Tolerance Test (OGTT). IGT determined by fasting glucose level > 100 mg/dL or > 140 mg/dL at 2 hours post glucose load |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madhusmita Misra | Massachusetts General Hospital | 617-724-5602 | mmisra@partners.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Placebo | Drug | Placebo will be administered by daily subcutaneous injections. Sham increases will be used. |
|
| Baseline and 6 months |
| Slattery MJ, Bredella MA, Thakur H, Torriani M, Misra M. Insulin resistance and impaired mitochondrial function in obese adolescent girls. Metab Syndr Relat Disord. 2014 Feb;12(1):56-61. doi: 10.1089/met.2013.0100. Epub 2013 Nov 19. |
| BG001 |
| Placebo/no Treatment |
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo. Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment. |
| BG002 | 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 |
|
| Placebo/no Treatment |
Forty subjects will be randomized to receive either recombinant human growth hormone or placebo. Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment. |
|
|
|
| Secondary | Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score | Homeostasis model assessment of insulin resistance (HOMA-IR) was used as a validated measure of insulin resistance. A 2-hour Oral Glucose Tolerance Test (OGTT) using 1.75 gram/kilogram of oral glucose (maximum 75 gram) will be performed at baseline and six months after administration of rhGH/placebo/ no therapy. Fasting insulin and glucose will be used to determine HOMA-IR: [fasting glucose (mmol/l) x fasting insulin (µU/ml)]/22.5] | Posted | Mean | Standard Deviation | HOMA-IR score | Baseline and 6 months |
|
|
|
|
| Primary | Changes in Lipid Panel | Lipid profile will be obtained using established methods. Total Cholesterol, Triglycerides, LDL and HDL measurements will be obtained at baseline, and then at the six-month visits to determine the rate at which lipid measures change with rhGH therapy | Posted | Mean | Standard Deviation | mg/dL | Baseline and 6 months |
|
|
|
|
| Primary | Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months | As a marker of cardiovascular risk, hs-CRP will be assessed at baseline and 6 months to assess the rate at which hs-CRP levels change with rhGH therapy. | Posted | Mean | Standard Deviation | mg/L | Baseline and 6 months |
|
|
|
|
| Primary | Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months | Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk | Posted | Mean | Standard Deviation | ng/mL | Baseline and 6 months |
|
|
|
|
| 0 |
| 11 |
| 10 |
| 11 |
| EG001 | Placebo/no Treatment | Forty subjects will be randomized to receive either recombinant human growth hormone or placebo. Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment. | 0 | 11 | 7 | 11 |
|
| Polyuria/Polydipsia | Endocrine disorders | Systematic Assessment |
|
| HbA1c > 6.4% | Endocrine disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Nausea with vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea without vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness without Headace | General disorders | Systematic Assessment |
|
| Blurry Vision | Eye disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Change in Menstrual Flow | Endocrine disorders | Systematic Assessment |
|
| Fatigue | Endocrine disorders | Systematic Assessment |
|
| Bruising/Irritation at Injection Site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Bruising/Irritation at Blood Sampling Site | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| ED visit for wheezing with URI | General disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Nasal Congestion | Infections and infestations | Systematic Assessment |
|
| Eczema | General disorders | Systematic Assessment |
|
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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 |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Change in LDL |
|
| Change in HDL |
|
| 0.57 |
| Superiority or Other (legacy) |
| Change in Low-density lipoprotein p-value | t-test, 2 sided | 0.062 | Superiority or Other (legacy) |
| Change in High-density lipoprotein p-value | t-test, 2 sided | 0.0396 | Superiority or Other (legacy) |