Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT06115304
Status:
UNKNOWN
Last Update Posted:
2023-11-03
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-30', 'lastUpdatePostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 1 hour'}, {'measure': 'Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 2 hours'}, {'measure': 'Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 3 hours'}, {'measure': 'Metabolomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 4 hours'}, {'measure': 'Proteomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 1 hour'}, {'measure': 'Proteomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 2 hours'}, {'measure': 'Proteomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 3 hours'}, {'measure': 'Proteomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 4 hours'}, {'measure': 'Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 1 hour'}, {'measure': 'Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 2 hour'}, {'measure': 'Peptidomics measured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 3 hours'}, {'measure': 'Peptidomicsmeasured in blood and cerebrospinalfluid using mass spectrometry', 'timeFrame': 'After 4 hours'}], 'primaryOutcomes': [{'measure': 'Appetite regulating hormones measured by specific immunoassays', 'timeFrame': 'After 1 hour'}, {'measure': 'Appetite regulating hormones measured by specific immunoassays', 'timeFrame': 'After 2 hour'}, {'measure': 'Appetite regulating hormones measured by specific immunoassays', 'timeFrame': 'After 3 hours'}, {'measure': 'Appetite regulating hormones measured by specific immunoassays', 'timeFrame': 'After 4 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Overweight and obesity are rising in prevalence and becoming a growing threat to public health. Obesity is associated with an increased all-cause mortality, impaired quality of life, and numerous of disorders. Therapeutic strategies against obesity - which include an abundance of dietary and physical training programmes and pharmaceutical drugs to increase energy expenditure or limit appetite or gastro-intestinal fat absorption - have shown limited success on long term weight loss. Thus, overweight and associated conditions is becoming the new normal and there is a need for better understanding gut-to-brain signalling, hormonal and metabolic disturbances in overweight individuals.\n\nThe purpose of this health science research project is to describe the coinciding plasma and cerebrospinal fluid (CSF) profiles of selected biomarkers after co-ingestion of a meal and model pharmaceuticals in patients with overweight and/or type 2 diabetes compared to healthy control individuals.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10 male patients with obesity (BMI \\>30) and type 2 diabetes\n* 10 male volunteers with normal weight (BMI 20-24) matched by age\n* 10 male volunteers with obesity (BMI \\>30) matched by age\n\nExclusion Criteria:\n\n1. Unwillingness to participate or wish to withdraw from ongoing protocol\n2. Hepatic disease or hemorrhagic diatheses (including abnormal International Normalized Ratio (INR), bilirubin, blood levels of thrombocytes, alanine-aminotransferase (ALAT))\n3. Anticoagulant treatment (e.g. treatment with warfarin, apixaban or another oral anticoagulant)\n4. Anaemia (p-hemoglobin below normal range)\n5. Nephropathy (se-creatinine \\>130 μM and/or albuminuria)\n6. Suspected difficult access to the spinal canal (e.g. pronounced scoliosis, spinal stenosis, osteoporotic coincidence in the lower back, spina bifida, meningocele after surgical intervention)\n7. Lumbar skin infection (e.g. herpes zoster, pustules or ulcers)\n8. Medical history with headaches - both in connection with dura puncture and frequent headaches of other types\n9. Central nervous system disease (including dementia, previous stroke, multiple sclerosis, epilepsy, etc.)\n10. Clinical suspicion of increased intracranial pressure (headaches, visual disturbances etc.)\n11. Patients with type 2 diabetes: Treatment with DPP-4 inhibitor or GLP-1 receptor agonist. Late diabetic complications including proliferative diabetic retinopathy (anamnestic), arteriosclerotic cardiovascular disease (heart failure or previous ischemic event/myocardial infarction)'}, 'identificationModule': {'nctId': 'NCT06115304', 'briefTitle': 'Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Postprandial Profiles of Metabolites and Appetite-regulating Hormones in Plasma and Cerebrospinal Fluid', 'orgStudyIdInfo': {'id': 'CSF-meal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention arm', 'interventionNames': ['Other: Large liquid meal, spinal catheter and venous line']}], 'interventions': [{'name': 'Large liquid meal, spinal catheter and venous line', 'type': 'OTHER', 'description': 'Large liquid meal (e.g. Nutricia® Energy 500 ml (750 kcal) admixed paracetamol 1000 mg (for estimation of gastric emptying).\n\nSpinal catheter for 4 hours, with samples taken at one hour interval.\n\n2 venous lines, one for saline and one for venous sampling every half hour', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Mikkel B Christensen, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Deparrtment of clinical pharmacology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Mikkel B Christensen, MD, PhD', 'role': 'CONTACT', 'email': 'Mikkel.bring.christensen@regionh.dk', 'phone': '+4538635102'}], 'overallOfficials': [{'name': 'Mikkel.bring.christensen@regionh.dk B Christensen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of clinical pharmacology, Bispebjerg Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mikkel Bring Christensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Chief consultent at the department of Clinical Pharmacology', 'investigatorFullName': 'Mikkel Bring Christensen', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}