Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-15 @ 1:11 PM
Study NCT ID:
NCT02440061
Status:
WITHDRAWN
Last Update Posted:
2018-04-02
First Post:
2015-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ghrelin and Beta Cell Function in Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'This protocol was replaced with a different one and therefore discontinued.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-29', 'studyFirstSubmitDate': '2015-05-07', 'studyFirstSubmitQcDate': '2015-05-08', 'lastUpdatePostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postprandial insulin secretion (ISR-meal)', 'timeFrame': 'approximately 8 weeks', 'description': 'Postprandial insulin secretion (ISR-meal) will be derived from plasma C-peptide concentrations during MTT (0-240 min) using deconvolution with population estimates of C-peptide clearance.'}, {'measure': 'Index of β-cell sensitivity to glucose', 'timeFrame': 'approximately 8 weeks', 'description': 'Index of β-cell sensitivity to glucose will be calculated as incremental insulin/glucose (I/G) AUC (ΔAUCI/G).'}, {'measure': 'Whole body insulin sensitivity using the Matsuda Index', 'timeFrame': 'approximately 8 weeks', 'description': 'The Matsuda Index is a well-known index of insulin sensitivity derived from several glucose and insulin values obtained during a mixed meal'}, {'measure': 'β-cell function (DI-meal)', 'timeFrame': 'approximately 8 weeks', 'description': 'β-cell function (DI-meal) will be calculated as ΔAUCI/G x Matsuda Index'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ghrelin', 'age, BMI, and gender matched controls'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Ghrelin is a hormone naturally produced in the stomach and the gut. The purpose of this research study is to determine the role of this gut hormone in the regulation of insulin secretion from the pancreas and glucose disposal after we eat. The investigators hypothesize that ghrelin has an effect on the pancreas and on how our body handles glucose after we eat. The investigators will compare insulin secretion and glucose changes during meal ingestion while either acyl ghrelin (AG) or saline (salt solution) is being infused through your vein on separate study days. AG is a form of the ghrelin hormone that has a small modification to it that allows it to bind to a specific receptor. The investigators hypothesize that AG has an effect on how the body handles glucose after a meal. AG has been approved by the U.S. Food and Drug Administration (FDA) for human research only. This study will also involve the use of a medicine called arginine, which is a naturally occurring product and found in many nutritional supplements. Its use in this study is investigational. The use of arginine helps maximize insulin release from the pancreas so the investigators can better examine whether AG affects insulin secretion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nT2DM study subjects to be considered for the study must meet the following inclusion criteria:\n\n1. Established T2DM with good to moderate glycemic control\n2. HbA1c \\< 8.5%\n3. Diabetes treatment with metformin, sulfonylurea, thiazolidinediones or combination of these medications; with no use of insulin during the study period\n4. BMI ≤ 45.0 kg/m2\n\nControl study subjects will be matched for age- (± 2 years), BMI (± 1.5 kg/m2) and gender and must meet the following inclusion criteria:\n\n1. HbA1c ≤ 5.7%\n2. Fasting plasma glucose ≤ 95 mg/dL\n3. BMI ≤ 45.0 kg/m2\n\nExclusion Criteria:\n\nAll subjects will be excluded for the following reasons:\n\n1. History of myocardial infarction or arrhythmia within the past year, abnormal electrocardiogram (ECG) with evidence of ischemia or arrhythmia, history or symptoms of congestive heart failure\n2. Uncontrolled hypertension\n3. History or active liver or renal disease (AST or ALT \\>2x upper limits of normal, calculated glomerular filtration rate \\[eGFR\\] \\<60 at screening)\n4. History of pituitary or adrenal disorders or neuroendocrine tumor\n5. Anemia defined as hematocrit \\<33% at screening\n6. Active cancer diagnosis or currently undergoing cancer treatment\n7. History of anorexia nervosa or previous gastrointestinal tract surgery\n8. Pregnancy or lactation\n\nControl subjects will be excluded for the following reasons:\n\n1. History or clinical evidence of impaired fasting glucose or impaired glucose tolerance on a 75 g OGTT, established diabetes mellitus, or taking medications prescribed for diabetes\n2. Use of medications that alter insulin sensitivity (i.e. niacin, glucocorticoids, metformin)'}, 'identificationModule': {'nctId': 'NCT02440061', 'briefTitle': 'Ghrelin and Beta Cell Function in Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Ghrelin Effect on Beta Cell Function in Health and Disease #2', 'orgStudyIdInfo': {'id': 'Pro00060865'}, 'secondaryIdInfos': [{'id': 'R01DK097550', 'link': 'https://reporter.nih.gov/quickSearch/R01DK097550', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study Group: Type 2 Diabetes Mellitus (T2DM)', 'description': 'Subjects with Type 2 Diabetes Mellitus (T2DM). Subjects will receive AG and saline infusions, but the order of which they receive will be random and they will not be told which one they are receiving on each given visit. Arginine will be used at both study visits.', 'interventionNames': ['Drug: Synthetic human AG', 'Drug: Arginine', 'Drug: 0.9% saline solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Control group of healthy subjects. Subjects will receive AG and saline, but the order of which they receive will be random and they will not be told which one they are receiving on each given visit. Arginine will be used at both study visits.', 'interventionNames': ['Drug: Synthetic human AG', 'Drug: Arginine', 'Drug: 0.9% saline solution']}], 'interventions': [{'name': 'Synthetic human AG', 'type': 'DRUG', 'description': 'Synthetic human AG (0.28 μg/kg) bolus over 1 minute followed by 2 μg/kg/hr continuous infusion for 4.5 hours.', 'armGroupLabels': ['Control Group', 'Study Group: Type 2 Diabetes Mellitus (T2DM)']}, {'name': 'Arginine', 'type': 'DRUG', 'description': 'Arginine hydrochloride (5 g) intravenously over 45 seconds.', 'armGroupLabels': ['Control Group', 'Study Group: Type 2 Diabetes Mellitus (T2DM)']}, {'name': '0.9% saline solution', 'type': 'DRUG', 'description': 'A continuous infusion of 0.9% saline solution (control) for 4.5 hours.', 'armGroupLabels': ['Control Group', 'Study Group: Type 2 Diabetes Mellitus (T2DM)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Center For Living', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Jenny Tong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jenny Tong, MD, MPH', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jenny Tong, MD, MPH', 'investigatorAffiliation': 'Duke University'}}}}