Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-01-03 @ 8:23 PM
Study NCT ID:
NCT01795235
Status:
UNKNOWN
Last Update Posted:
2013-02-20
First Post:
2013-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018761', 'term': 'Multiple Endocrine Neoplasia Type 1'}], 'ancestors': [{'id': 'D009377', 'term': 'Multiple Endocrine Neoplasia'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009378', 'term': 'Neoplasms, Multiple Primary'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D005934', 'term': 'Glucagon'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D001262', 'term': 'Atenolol'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D010187', 'term': 'Pancreatic 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'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-02-19', 'studyFirstSubmitDate': '2013-02-12', 'studyFirstSubmitQcDate': '2013-02-19', 'lastUpdatePostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Circulating acyl-ghrelin concentration after glucagon stimulation with and without beta-adrenergic blockade', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Association between circulating acyl-ghrelin concentration and GH and cortisol after glucagon administration with and without beta-adrenergic blockade', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['men'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Glucagon has been used for decades as a test of growth hormone (GH) reserve. The pathway by which GH is stimulated by glucagon is not established. Acyl ghrelin has been shown to increase GH levels and to be stimulated by an increase in adrenergic activity. The proposed study will test the concept that with the fall in blood glucose it is likely that there is a sympathetic discharge which contributes to the increase in acyl ghrelin and indirectly leads to the increase in GH and cortisol.', 'detailedDescription': 'Glucagon given to healthy adults in doses of 1-1.5 mg i.m. has been shown to result in a peak glucagon level in the circulation after 30 min, followed by an increase in glucose and insulin levels. The subsequent decline in glucose, insulin and glucagon was followed by an increase in cortisol and GH. Ghrelin is a 28 amino acid peptide which is released from the fundus of the stomach, within the oxyntic glands and the small intestine. It circulates in two major forms, acylated and des-acylated ghrelin. Acylated ghrelin has strong GH-releasing effects which are mediated via the G-protein coupled ghrelin receptor. The proposed study will test the concept that with the fall in blood glucose during a glucagon test it is likely that there is a sympathetic discharge which contributes to the increase in acyl ghrelin and indirectly leads to the increase in GH and cortisol.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy normal men\n2. Age 18-30 yrs\n3. BMI 18-27 kg/m2\n\nExclusion Criteria:\n\n1. Medication or previous surgery known to affect ghrelin secretion.\n2. Medications known to have an impact on body weight (Seroquel, tricyclic antidepressants).\n3. Medications known to have an impact on the beta adrenergic system.\n4. Coronary artery disease, congestive heart failure, peripheral vascular disease, diabetes mellitus, significant hypertension (BP \\>180 systolic or \\>100 diastolic at rest); renal, hepatic, pulmonary disease; untreated hypothyroidism, untreated hyperthyroidism; history of seizure disorder; history of malignancy (other than some skin cancers), history of active chronic infections (e.g., HIV, tuberculosis).\n5. Endocrine disorders, i.e., pheochromocytoma, adrenal insufficiency\n6. Hematocrit \\< 41% men\n7. History of daily tobacco use within past 3 months\n8. Chronic alcohol abuse by history\n9. Weight not stable (more than 10% weight change or more over past 6 months)\n10. Strenuous exercise for average of more than 60 min/day\n11. Investigational drug within past 6 weeks\n12. Psychiatric history especially eating disorders\n13. Transmeridian travel within 2 weeks prior to or during study\n14. Known hypersensitivity to beta-blockers\n15. Estimated Glomerular Filtration Rate below 60 mL/min/1.73m2.\n16. Known cardiac dysrhythmia, especially first degree heart block. -'}, 'identificationModule': {'nctId': 'NCT01795235', 'briefTitle': 'Study of Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones', 'organization': {'class': 'OTHER', 'fullName': 'University of Virginia'}, 'officialTitle': 'Glucagon, Ghrelin and Growth Hormone as Counterregulatory Hormones', 'orgStudyIdInfo': {'id': '16391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Saline s.c. injection and placebo tablet', 'description': 'Saline s.c. injection and one placebo tablet (preceded by one placebo tablet per day at 0900h for two days before admission).', 'interventionNames': ['Drug: Saline', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'glucagon s.c. injection and placebo tablet', 'description': '1 mg glucagon s.c. injection and one placebo tablet (preceded by one placebo tablet per day at 0900h for two days before admission).', 'interventionNames': ['Drug: Glucagon', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Saline s.c. injection and atenolol tablet', 'description': 'Saline s.c. injection and 100 mg atenolol tablet', 'interventionNames': ['Drug: Saline', 'Drug: Atenolol']}, {'type': 'OTHER', 'label': 'glucagon s.c. injection and atenolol tablet', 'description': '1 mg glucagon s.c. injection and 100 mg atenolol tablet', 'interventionNames': ['Drug: Glucagon', 'Drug: Atenolol']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'otherNames': ['NormalSaline', '0.9% Sodium Chloride Solution'], 'description': 'Saline s.c.', 'armGroupLabels': ['Saline s.c. injection and atenolol tablet', 'Saline s.c. injection and placebo tablet']}, {'name': 'Glucagon', 'type': 'DRUG', 'otherNames': ['Glucagon for injection'], 'description': 'Glucagon s.c.', 'armGroupLabels': ['glucagon s.c. injection and atenolol tablet', 'glucagon s.c. injection and placebo tablet']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar Pill', 'armGroupLabels': ['Saline s.c. injection and placebo tablet', 'glucagon s.c. injection and placebo tablet']}, {'name': 'Atenolol', 'type': 'DRUG', 'otherNames': ['Tenormin'], 'description': 'Beta-1 receptor antagonist', 'armGroupLabels': ['Saline s.c. injection and atenolol tablet', 'glucagon s.c. injection and atenolol tablet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ralf Nass, MD', 'role': 'CONTACT', 'email': 'rmn9a@virginia.edu'}, {'name': 'Michael O Thorner', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Ralf Nass, MD', 'role': 'CONTACT', 'email': 'rmn9a@virginia.edu'}], 'overallOfficials': [{'name': 'Michael O Thorner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Virginia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Virginia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Michael Thorner, MD', 'investigatorAffiliation': 'University of Virginia'}}}}