Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-02-26 @ 4:19 PM
Study NCT ID:
NCT03651661
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2018-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pupillography as Screening Tool for Brain Insulin Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2018-07-02', 'studyFirstSubmitQcDate': '2018-08-27', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurements of autonomic nervous system activity by pupillography', 'timeFrame': 'Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application', 'description': 'There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The primary variable is the pupil width change in pupillography before compared to after intranasal insulin/placebo administration in 30 lean subjects. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). In this case, the pupil width is recorded for 6 minutes continuously before and after nasal insulin (also 16 strokes of 10 E) or placebo doses with an infrared camera permanently mounted in a video goggle. Additionally, a possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameters are latency, amplitude and re-dilatation behavior.'}, {'measure': 'Measurements of latency of pupil response to light stimulation.', 'timeFrame': 'Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application', 'description': 'There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). A possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameter is latency. The responses before and after nasal spray administration will be compared.'}, {'measure': 'Measurements of amplitude of pupil response to light stimulation.', 'timeFrame': 'Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application', 'description': 'There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). A possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameter is amplitude . The responses before and after nasal spray administration will be compared.'}, {'measure': 'Measurements of re-dilation behaviour of pupil response to light stimulation.', 'timeFrame': 'Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application', 'description': 'There will be measurements of autonomic nervous system activity by pupillography in order to identify central insulin action. The investigation takes place in a darkened room with low backlight of about 5-10lx. The pupillographic recording is carried out with a commercially available device, F2D2 (Amtech Germany). A possible change of the pupillary light reflection to monochromatic light is measured. Evaluation parameter is re-dilatation behavior. The responses before and after nasal spray administration will be compared.'}], 'secondaryOutcomes': [{'measure': 'Autonomic nervous system', 'timeFrame': 'Measurements baseline and change to baseline 15 minutes and 30 minutes after spray application', 'description': 'effect of nasal insulin or placebo spray on autonomic nervous system tone measured by heart rate variability.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Cerebral insulin action is important in the regulation of whole body glucose metabolism. However, the cerebral insulin action differs between individuals - there is a so called cerebral insulin resistance. The influence of central insulin action on peripheral metabolism seems at least partially mediated via the autonomous nervous system. A noninvasive method to measure autonomic function is the pupillography. The aim of the study is to find out whether pupillography can be used to assess central insulin activity. Thus, pupillography will be performed in 30 normal weight and 30 overweight subjects before and after application insulin intranasally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* voluntary adults\n* HbA1c \\<5.8%\n* Age between 18 and 60 years\n* written consent\n\nExclusion Criteria:\n\n* There is a pregnancy or pregnancy can not be excluded\n* lactating women\n* Minors or non-consenting subjects are also excluded\n* Acute illness or infection within the last 4 weeks\n* Neurological and psychiatric disorders\n* intake of centrally acting drugs\n* Subjects with hemoglobin levels Hb \\<12g / dl (in females), Hb \\<14g / dl (males)\n* Allergic diseases against one of the substances used'}, 'identificationModule': {'nctId': 'NCT03651661', 'briefTitle': 'Pupillography as Screening Tool for Brain Insulin Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Pupillographie Als Screeningtest für Cerebrale Insulinresistenz', 'orgStudyIdInfo': {'id': '567/20168O2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nasal insulin', 'description': '160 U of human insulin as nasal spray', 'interventionNames': ['Drug: human insulin', 'Diagnostic Test: Pupillography']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'nasal placebo', 'description': 'placebo as nasal spray', 'interventionNames': ['Drug: placebo', 'Diagnostic Test: Pupillography']}], 'interventions': [{'name': 'human insulin', 'type': 'DRUG', 'description': 'human insulin administered as nasal spray', 'armGroupLabels': ['nasal insulin']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo administered as nasal spray', 'armGroupLabels': ['nasal placebo']}, {'name': 'Pupillography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Autonomic tone will be adressed by pupillography using the F2D2 (Amtech Germany) device.', 'armGroupLabels': ['nasal insulin', 'nasal placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University of Tuebingen, Department of Internal Medicine IV', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}