Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT02791867
Status:
TERMINATED
Last Update Posted:
2018-11-27
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Laboratory Changes, Food Intake and Metabolic Profile in Patients With Obesity and Type2 Diabetes Mellitus: Before, During and After Taking AphoelineBrake
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'The study drug was not provided resulting in termination for unacceptable delays', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-26', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-06-01', 'lastUpdatePostDateStruct': {'date': '2018-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Insulin Resistance measured by HOMA-IR', 'timeFrame': '12 months from intervention', 'description': 'Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin levels.'}, {'measure': 'Reduction in glycated Haemoglobin measured: HBA1c', 'timeFrame': '12 months from intervention', 'description': 'HbA1c refers to glycated haemoglobin. It develops when haemoglobin, joins with glucose in the blood.'}], 'secondaryOutcomes': [{'measure': 'Reduction in serum triglyceride level (mmol/l)', 'timeFrame': '12 months from intervention'}]}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine if subjects taking the natural product AphoelineBrake™ in addition to their standard treatment experience differences in metabolic disease control, gastrointestinal hormones and inflammatory markers diet, hunger, satiety, weight, compared to patients taking a placebo in addition to their standard treatment. The secondary objective is to study the effect of Aphoeline Brake on oxidative and inflammatory stress markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥21 years\n* Diagnosis of T2DM\n* Metformin as first line treatment\n* HbA1c ≥7\n* Calculated HOMA-IR ≥3.0,\n* BMI 25-45\n* Triglyceride level ≥ 2.26 mmol/L\n\nExclusion Criteria:\n\n* Age \\<21 years of age\n* BMI ≤ 25\n* Pregnant\n* Subjects on chronic nonsteroidal anti-inflammatory drugs or systemic corticosteroids.\n* Subjects treated with Liraglutide (Victoza®).\n* Renal, hepatic or cardiac failure.\n* Subjects with a significant clinical illness within a month before the first administration of Aphoeline Brake™\n* Subjects diagnosed with Irritable Bowel Syndrome.\n* Subjects diagnosed with Ulcerative Colitis or Crohn's disease.\n* History of significant gastrointestinal disease.\n* Poor venous access.\n* Poor likelihood to adhere with study procedures, as documented during the MyFitnessPal procedures prior to use of Aphoeline Brake™"}, 'identificationModule': {'nctId': 'NCT02791867', 'briefTitle': 'Comparison of Laboratory Changes, Food Intake and Metabolic Profile in Patients With Obesity and Type2 Diabetes Mellitus: Before, During and After Taking AphoelineBrake', 'organization': {'class': 'OTHER', 'fullName': 'Dasman Diabetes Institute'}, 'orgStudyIdInfo': {'id': 'RA 2014-019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'AphoelineBrake administration', 'interventionNames': ['Drug: AphoelineBrake']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Administration', 'interventionNames': ['Drug: AphoelineBrake']}], 'interventions': [{'name': 'AphoelineBrake', 'type': 'DRUG', 'description': 'The study is proposed as a placebo controlled randomized controlled trial with an intervention (AphoelineBrake) in addition to their standard treatment in comparison to a standard treatment control arm receiving an identical placebo. Prior to the commencement of any study procedures, participants will document informed consent and acknowledgement of privacy rights. Participants will be seen for initial consenting procedures, initial study procedures, and follow-up procedures at the Dasman Diabetes Institute clinic.Scheduled study visits will occur at Day 0, Day 7, Months: 1, 3, 6, 9, and 12 months in accordance with standards of medical care.', 'armGroupLabels': ['Active', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kuwait City', 'country': 'Kuwait', 'facility': 'Dasman DIabetes Institute', 'geoPoint': {'lat': 29.367, 'lon': 47.97429}}], 'overallOfficials': [{'name': 'Nadia Zghoul, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dasman Diabetes Institute'}, {'name': 'Jerome Schentag, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo, New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dasman Diabetes Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'University at Buffalo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}