Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2026-03-01 @ 12:05 PM
Study NCT ID:
NCT03805802
Status:
COMPLETED
Last Update Posted:
2020-10-22
First Post:
2019-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D015431', 'term': 'Weight Loss'}], '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'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigator receives reference product and the test product in boxes labelled "stratus" "nimbus" and "cumulus". first 6 weeks participants are randomly assigned to "stratus" or "nimbus" and the second 6 weeks participants all receive "cumulus".'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'First 6 weeks double blinded vs. a reference product and second 6 weeks open label both groups receive the test product in the second 6 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-20', 'studyFirstSubmitDate': '2019-01-13', 'studyFirstSubmitQcDate': '2019-01-13', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Systolic lood pressure', 'timeFrame': '6 weeks', 'description': 'Systolic blood pressure left arm 6 weeks in mm/Hg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '6 weeks', 'description': 'Diastolic blood pressure left arm 6 weeks in mm/Hg'}, {'measure': 'Systolic blood pressure', 'timeFrame': '12 weeks', 'description': 'Systolic blood pressure left arm 12 weeks in mm/Hg'}, {'measure': 'Diastolic blood pressure', 'timeFrame': '12 weeks', 'description': 'Diastolic blood pressure left arm 12 weeks in mm/Hg'}, {'measure': 'Waist circumference', 'timeFrame': '6 weeks', 'description': 'Waist circumference at 6 weeks in cm'}, {'measure': 'Waist circumference', 'timeFrame': '12 weeks', 'description': 'Waist circumference at 12 weeks in cm'}], 'primaryOutcomes': [{'measure': 'Fasting glucose', 'timeFrame': '6 weeks', 'description': 'Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 6 weeks.'}], 'secondaryOutcomes': [{'measure': 'Fasting glucose', 'timeFrame': '12 weeks', 'description': 'Change in the concentratino of fasting venous glucose of daily LOB consumption in mg/dl as compared to the change in fasting glucose for the placebo group at 12 weeks.'}, {'measure': 'HBA1c', 'timeFrame': '6 weeks', 'description': 'long-term glucose control as measured by the concentratino of HbA1c concentration in %'}, {'measure': 'HBA1c', 'timeFrame': '12 weeks', 'description': 'long-term glucose control as measured by the concentratino of HbA1c concentration in %'}, {'measure': 'Self-documented glucose', 'timeFrame': '6 weeks', 'description': 'Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl'}, {'measure': 'Self-documented glucose', 'timeFrame': '12 weeks', 'description': 'Self-monitored glucose levels extracted from glucometers as a mean of the previous two weeks before study visits in mg/dl'}, {'measure': 'Weight', 'timeFrame': '6 weeks', 'description': 'Chenge in body Weight in kg'}, {'measure': 'Weight', 'timeFrame': '12 weeks', 'description': 'Chenge in body Weight in kg'}, {'measure': 'BMI', 'timeFrame': '6 weeks', 'description': 'Body Mass Index'}, {'measure': 'BMI', 'timeFrame': '12 weeks', 'description': 'Body Mass Index'}, {'measure': 'Lipid metabolism: Serum triglycerides', 'timeFrame': '6 weeks', 'description': 'Markers of lipid metabolism at 6 weeks: triglycerides (mg/dl)'}, {'measure': 'Lipid metabolism: Serum triglycerides', 'timeFrame': '12 weeks', 'description': 'Markers of lipid metabolism at 12 weeks: triglycerides (mg/dl)'}, {'measure': 'Lipid metabolism: apolipoprotein A (mg/dl)', 'timeFrame': '6 weeks', 'description': 'Markers of lipid metabolism at 6 weeks: apolipoprotein A (mg/dl)'}, {'measure': 'Lipid metabolism: apolipoprotein A (mg/dl)', 'timeFrame': '12 weeks', 'description': 'Markers of lipid metabolism at 12 weeks: apolipoprotein A (mg/dl)'}, {'measure': 'Lipid metabolism: Apolipoprotein B mg/dl', 'timeFrame': '6 weeks', 'description': 'Markers of lipid metabolism at 6 weeks: Apolipoprotein B mg/dl'}, {'measure': 'Lipid metabolism: Apolipoprotein B mg/dl', 'timeFrame': '12 weeks', 'description': 'Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl'}, {'measure': 'Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio', 'timeFrame': '6 weeks', 'description': 'Metabolism at 6 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio'}, {'measure': 'Lipid metabolism: Apolipoprotein B / Apolipoprotein A ratio', 'timeFrame': '12 weeks', 'description': 'Markers of lipid metabolism at 12 weeks: Apolipoprotein B mg/dl / Apolipoprotein A mg/dl ratio'}, {'measure': 'Lipid metabolism: HDL-cholesterol', 'timeFrame': '6 weeks', 'description': 'Markers of lipid metabolism at 6 weeks: HDL-cholesterol mg/dl'}, {'measure': 'Lipid metabolism: HDL-cholesterol', 'timeFrame': '12 weeks', 'description': 'Markers of lipid metabolism at 12 weeks: HDL-cholesterol mg/dl'}, {'measure': 'Lipid metabolism: LDL- cholesterol mg/dl', 'timeFrame': '6 weeks', 'description': 'Markers of lipid metabolism at 6 weeks: LDL- cholesterol mg/dl'}, {'measure': 'Lipid metabolism: LDL- cholesterol mg/dl', 'timeFrame': '12 weeks', 'description': 'Markers of lipid metabolism at 12 weeks: LDL- cholesterol mg/dl'}, {'measure': 'Microbiome', 'timeFrame': '6 weeks', 'description': 'Microbiome in faeces samples at 6 weeks'}, {'measure': 'Microbiome', 'timeFrame': '12 weeks', 'description': 'Microbiome in faeces samples at 12 weeks'}, {'measure': 'Inflammation: Il-6', 'timeFrame': '6 weeks', 'description': 'Markers of inflammation at 6 weeks IL-6 in ng/ml'}, {'measure': 'Inflammation: hsCRP', 'timeFrame': '6 weeks', 'description': 'Markers of inflammation at 6 weeks hsCRP mg/l'}, {'measure': 'Inflammation: Il-6', 'timeFrame': '12 weeks', 'description': 'Markers of inflammation at 12 weeks IL-6 in ng/ml'}, {'measure': 'Inflammation: hsCRP', 'timeFrame': '12 weeks', 'description': 'Markers of inflammation at 12 weeks hsCRP mg/l'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fiber', 'type 2 diabetes', 'dietary intervention', 'weight loss', 'glucose control', 'obesity', 'overweight', 'metabolic syndrome', 'oats'], 'conditions': ['Diabetes Mellitus, Type 2', 'Obesity', 'Overweight', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. After the first 6 weeks both groups will be switched to the high fiber product.', 'detailedDescription': 'It has previously been shown that an increase in the consumption of fiber improves glucose control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran high in fiber will be studied in type 2 diabetes patients with inadequate glucose control that are treated with oral medication or with additional once-daily insulin only against a reference product. 30 patients will be treated with the oat bran product or reference product over a period of 6 weeks in a double blinded approach, hereafter all participants will be switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks. Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented glucose as well as the body weight and body mass index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 Diabetes with inadequate glucose control and a HbA1c \\>7,5 and \\< 9%\n* Treatment with all oral antidiabetic medication or injectable GLP-1 analogues\n* BMI 28,0-39,9 kg/m²\n* Age 30-70 years\n\nExclusion Criteria:\n\n* insulin treatment\n* Psychiatric Disease\n* Acute Infections\n* Alcohol or drug abuse\n* Acute diverticulitis\n* Malignant tumors or hematologic disorders\n* Heart failure NYHA III-IV\n* Acute coronary syndrome\n* Chronic kidney disease \\> Stage 3 (KDOQI)\n* Pregnancy or Lactation\n* Previous bariatric interventions'}, 'identificationModule': {'nctId': 'NCT03805802', 'briefTitle': 'Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Stoffwechselzentrum Rhein - Pfalz'}, 'officialTitle': 'Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes', 'orgStudyIdInfo': {'id': '012019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'active product', 'description': 'Once daily ad libitum consumption of one package of the fiber product 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).', 'interventionNames': ['Other: active product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'reference product', 'description': 'Once daily ad libitum consumption of one package of placebo during 6 weeks (blinded phase). Once daily ad libitum consumption of one package of the fiber product 6 weeks (open phase).', 'interventionNames': ['Other: active product', 'Other: reference product']}], 'interventions': [{'name': 'active product', 'type': 'OTHER', 'otherNames': ['LOB', 'Liquid Oat Bran', 'High fiber product'], 'description': 'Once daily consumption over the period of the study', 'armGroupLabels': ['active product', 'reference product']}, {'name': 'reference product', 'type': 'OTHER', 'otherNames': ['placebo food product'], 'description': 'Once daily consumption over the period of the study', 'armGroupLabels': ['reference product']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68163', 'city': 'Mannheim', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Stoffwechselzentrum Rhein-Pfalz', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Per M Humpert, M. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director of Stoffwechselzentrum Rhein-Pfalz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stoffwechselzentrum Rhein - Pfalz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Glucanova AB', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Stoffwechselzentrum Rhein - Pfalz', 'investigatorFullName': 'Dr. Per Humpert', 'investigatorAffiliation': 'Stoffwechselzentrum Rhein - Pfalz'}}}}