Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2025-12-30 @ 12:12 PM
Study NCT ID:
NCT01169103
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2010-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013006', 'term': 'Growth Hormone'}], 'ancestors': [{'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mmisra@partners.org', 'phone': '617-724-5602', 'title': 'Madhusmita Misra', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Recombinant Human Growth Hormone', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.\n\nrecombinant 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.', 'otherNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo/no Treatment', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.\n\nPlacebo : 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.', 'otherNumAtRisk': 11, 'otherNumAffected': 7, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Impaired Glucose Tolerance', 'notes': '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', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Polyuria/Polydipsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'HbA1c > 6.4%', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea with vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea without vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness without Headace', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurry Vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Change in Menstrual Flow', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising/Irritation at Injection Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bruising/Irritation at Blood Sampling Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ED visit for wheezing with URI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Human Growth Hormone', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.\n\nrecombinant 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.'}, {'id': 'OG001', 'title': 'Placebo/no Treatment', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.\n\nPlacebo : 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.'}], 'classes': [{'title': 'Change in VAT', 'categories': [{'measurements': [{'value': '57', 'spread': '2993', 'groupId': 'OG000'}, {'value': '799', 'spread': '3184', 'groupId': 'OG001'}]}]}, {'title': 'Change in SAT', 'categories': [{'measurements': [{'value': '-111', 'spread': '6078', 'groupId': 'OG000'}, {'value': '3634', 'spread': '5161', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'We assumed that mean decrease in visceral fat in our population would be 0.85\\*standard deviation score (SDS). Therefore, 18 subjects in each group would be required in order for us to have an 81.7% chance of detecting a significant difference in the mean 6-month changes in visceral adiposity between the groups at a 5% significance level by rejecting the null hypothesis that there is no difference in change in visceral fat following administration of rhGH or placebo in obese adolescent girls.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in SAT p-value', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)', 'unitOfMeasure': 'mm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Human Growth Hormone', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.\n\nrecombinant 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.'}, {'id': 'OG001', 'title': 'Placebo/no Treatment', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.\n\nPlacebo : 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.52', 'spread': '2.63', 'groupId': 'OG000'}, {'value': '-2.92', 'spread': '8.23', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': '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\\]', 'unitOfMeasure': 'HOMA-IR score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in Lipid Panel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Human Growth Hormone', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.\n\nrecombinant 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.'}, {'id': 'OG001', 'title': 'Placebo/no Treatment', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.\n\nPlacebo : 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.'}], 'classes': [{'title': 'Change in Total Cholesterol', 'categories': [{'measurements': [{'value': '-37.8', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '-8.6', 'spread': '15.5', 'groupId': 'OG001'}]}]}, {'title': 'Change in Triglycerides', 'categories': [{'measurements': [{'value': '-27.8', 'spread': '46.8', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '58.4', 'groupId': 'OG001'}]}]}, {'title': 'Change in LDL', 'categories': [{'measurements': [{'value': '-25.8', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '-10.7', 'spread': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Change in HDL', 'categories': [{'measurements': [{'value': '-6.6', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '1', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Change in Total Cholesterol p-value', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Triglyceride p-value', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in Low-density lipoprotein p-value', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0396', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Change in High-density lipoprotein p-value', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': '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', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Human Growth Hormone', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.\n\nrecombinant 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.'}, {'id': 'OG001', 'title': 'Placebo/no Treatment', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.\n\nPlacebo : 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.77', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.58', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': '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.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Human Growth Hormone', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.\n\nrecombinant 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.'}, {'id': 'OG001', 'title': 'Placebo/no Treatment', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.\n\nPlacebo : 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-22.2', 'spread': '30.3', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '33.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Recombinant Human Growth Hormone', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.\n\nrecombinant 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.'}, {'id': 'FG001', 'title': 'Placebo/no Treatment', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.\n\nPlacebo : 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were recruited at Massachusetts General Hospital between September 2010 and October 2012 through area pediatric and obesity clinics and advertisements.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Recombinant Human Growth Hormone', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.\n\nrecombinant 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.'}, {'id': 'BG001', 'title': 'Placebo/no Treatment', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.\n\nPlacebo : 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.2', 'spread': '2.6', 'groupId': 'BG000'}, {'value': '16.9', 'spread': '2.1', 'groupId': 'BG001'}, {'value': '16.6', 'spread': '2.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-22', 'studyFirstSubmitDate': '2010-07-22', 'resultsFirstSubmitDate': '2013-12-10', 'studyFirstSubmitQcDate': '2010-07-22', 'lastUpdatePostDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-18', 'studyFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visceral and Subcutaneous Abdominal Adipose Tissue Over 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'Visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAT) were assessed using single slice MR imaging (MRI)'}, {'measure': 'Changes in Lipid Panel', 'timeFrame': 'Baseline and 6 months', 'description': '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'}, {'measure': 'Change in High-sensitivity C-reactive Protein (Hs-CRP) Over 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': '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.'}, {'measure': 'Change in Soluble Intercellular Adhesion Molecule-1 (sICAM) Over 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'Soluble intercellular adhesion molecule-1 (sICAM) was used as a surrogate marker of cardiovascular risk'}], 'secondaryOutcomes': [{'measure': 'Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) Score', 'timeFrame': 'Baseline and 6 months', 'description': '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\\]'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Adolescent', 'Insulin resistance', 'Growth hormone', 'Visceral fat', 'Adolescent obesity'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '25435886', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '24251951', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescent girls 13-21 years old with bone age ≥ 14 years\n* Overweight girls: Body Mass Index (BMI) greater than the 95th percentile for age\n* Waist/Hip ratio ≥ 0.85\n* Insulin Like Growth Factor -1 (IGF-1) below -0.5 standard deviations (SD) for pubertal stage or age\n\nExclusion Criteria:\n\n* Pregnancy (positive pregnancy test) prior to enrollment in the study\n* Significant weight gain or loss within 3 months of study (more than 5 kg)\n* Use of medications that affect GH or cortisol levels (such as estrogen including oral contraceptive pills, oral glucocorticoids)\n* Use of medications such as Meridian and Orlistat\n* Presence of diabetes mellitus\n* Uncontrolled Thyroid disorders\n* Chronic renal insufficiency\n* Participation in another simultaneous medical investigation or trial\n* Active neoplasm or history of cancer\n* Prader-Willi syndrome\n* History of scoliosis if bone age is \\<15 years\n* Hypersensitivity to rhGH or constituents of the injections'}, 'identificationModule': {'nctId': 'NCT01169103', 'briefTitle': 'Effect of Recombinant Human Growth Hormone (rhGH) on Abdominal Fat and Cardiovascular Risk in Obese Girls', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Effect of rhGH Administration on Visceral Adiposity and Markers of Cardiovascular Risk in Obese Adolescent Girls: Phase 2', 'orgStudyIdInfo': {'id': '2009P000861'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'recombinant human growth hormone', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.', 'interventionNames': ['Drug: recombinant human growth hormone (rhGH)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'recombinant human growth hormone (rhGH)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['recombinant human growth hormone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered by daily subcutaneous injections. Sham increases will be used.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Madhusmita Misra, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Madhusmita Misra', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}