Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-03 @ 9:01 PM
Study NCT ID:
NCT02196350
Status:
COMPLETED
Last Update Posted:
2019-10-25
First Post:
2014-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
P4 Approach in Diabetes Type 2
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': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2014-07-16', 'studyFirstSubmitQcDate': '2014-07-18', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c levels', 'timeFrame': 'In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months', 'description': 'Changes in primary outcome measures will be determined by using a mixed model'}, {'measure': 'Change in 2h glucose levels', 'timeFrame': 'In-study at week 0 (baseline) and 13;', 'description': '2h glucose will be measured after Oral Glucose Tolerance Test (OGTT). Changes in primary outcome measures will be determined by using a mixed model'}, {'measure': 'Change in fasting blood glucose levels', 'timeFrame': 'In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months', 'description': 'After 8 hour fasting. Changes in primary outcome measures will be determined by using a mixed model.'}, {'measure': 'percentage of participants that reach normoglycemia', 'timeFrame': 'end of study (after 13 weeks)', 'description': 'normoglycemia is determined by fasting blood glucose level of less than 6.1 mmol/L'}], 'secondaryOutcomes': [{'measure': 'body weight', 'timeFrame': 'screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months', 'description': 'measured by the general practitioner assistant'}, {'measure': 'blood pressure', 'timeFrame': 'screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months', 'description': 'measured by the general practitioner assistant'}, {'measure': 'waist circumference', 'timeFrame': 'screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months', 'description': 'measured by general practitioner assistant'}, {'measure': 'body fat percentage', 'timeFrame': 'screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months', 'description': 'measured by general practitioner assistant'}, {'measure': 'change indices for muscle insulin resistance', 'timeFrame': 'screening; in-study at week 0 and 13;', 'description': 'at week 0 and 13 the indices will be calculated from Oral glucose tolerance test data.\n\nBlood will be collected at the blood collection centre in Hillegom'}, {'measure': 'health behaviour change', 'timeFrame': 'in-study at week 0, 13; during follow-up at 6, 12 and 24 months', 'description': 'established by comparing baseline values with end of study values for food intake and physical activity as measured by a Lifestyle-questionnaire'}, {'measure': 'change in vitality as assessed with a vitality questionnaire (Vita-16)', 'timeFrame': 'in-study at week 0, 13; during follow-up at 6, 12 and 24 months'}, {'measure': 'change in subjective quality of life as assessed with RAND-36 questionnaire', 'timeFrame': 'in-study at week 0, 13; during follow-up at 6, 12 and 24 months'}, {'measure': 'change in indices for beta cell function', 'timeFrame': 'screening; in-study at week 0 and 13;', 'description': 'at week 0 and 13 the indices will be calculated from Oral glucose tolerance test data.\n\nBlood will be collected at the blood collection centre in Hillegom'}, {'measure': 'change in indices for hepatic insulin resistance', 'timeFrame': 'screening; in-study at week 0 and 13;', 'description': 'at week 0 and 13 the indices will be calculated from Oral glucose tolerance test data.\n\nBlood will be collected at the blood collection centre in Hillegom'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['personalized treatment', 'prevention', 'improved diagnosis'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The study aims to assess the impact of the P4 approach on established markers of glucose metabolism in type 2 diabetics.\n\nSecondary objectives are examination of the changes in physical characteristics, quality of life and the indices for beta cell function, hepatic insulin resistance and muscle insulin resistance .', 'detailedDescription': 'This study will be a proof-of-principle exploratory study. Subjects in the P4 program will receive a personalized diagnosis and treatment. After investigation of the status of the different organs involved in diabetes (liver, muscle, pancreas), subjects in the P4 group are divided into 3 subgroups. Each subgroup receives a personalized lifestyle advice. This lifestyle advice may comprise different interventions, i.e. very low calorie diet, low calorie diet, strength training, endurance training. Dependent on the type of intervention, these interventions will be supervised by a dietitian or physiotherapist.\n\nAll subjects will visit a central study center 5 times during the study and 3 times during follow-up. During these visits physical measures will be taken and data will be collected by the general practitioner assistant.\n\nAfter the three month intervention period the subjects will return to usual care via the general practitioner.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy as assessed by the\n\n * health and lifestyle questionnaire, (P9607 F02; in Dutch)\n * physical examination\n * results of the pre-study laboratory tests\n2. Age 30-80 years\n3. Stable BMI 25-35 kg/m2\n4. Diagnosis diabetes type 2 based upon:\n\n Fasting glucose \\>6.9 mmol/l on two different days or one measurement of non-fasting glucose \\>11.0 mmol/l in combination with symptoms of hyperglycemia\n5. Duration of diabetes maximally 1 year\n6. Informed consent signed;\n7. Willing to comply with the study procedures during the study;\n8. Appropriate veins for blood sampling/ cannula insertion according to the general practitioner assistant (GPA);\n9. Voluntary participation\n10. Physically able to perform training activities\n11. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.\n\nExclusion Criteria:\n\n1. Use of insulin, corticosteroids (systemic), or beta-blockers in past month\n2. Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes\n3. Slow onset type 1 diabetes\n4. Use of oral diabetes medication in past year\n5. (Having a history of a) medical condition that might significantly affect the study outcome as judged by the medical investigator and health and life style questionnaire. This includes diabetes type 1, gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder.\n6. Hypertension: systolic blood pressure \\>160 mmHg, diastolic blood pressure \\>90 mmHg\n7. Kidney problems based upon proteinuria and creatinine \\>150 mmol/l\n8. Insufficient beta cell function based on Disposition index \\< 1.5 as determined during the OGTT in study on day 01\\*\n9. Physical activity higher than according to the Diabetes guidelines (moderate intensity one hour a day, seven days a week (overweight adults))\n10. Alcohol consumption \\> 21 (women) - 28 (men) units/week\n11. Reported unexplained weight loss or gain of \\> 2 kg in the month prior to the pre-study screening\n12. Recent blood donation (\\<1 month prior to the start of the study)\n13. Not willing to give up blood donation during the study\n14. Personnel of TNO and their partner\n15. Not having a general practitioner\n16. Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.'}, 'identificationModule': {'nctId': 'NCT02196350', 'acronym': 'P4P-Hillegom', 'briefTitle': 'P4 Approach in Diabetes Type 2', 'organization': {'class': 'OTHER', 'fullName': 'TNO'}, 'officialTitle': 'The Impact of the P4 Approach, Preventive, Predictive, Personalized and Participatory in Newly Diagnosed Type 2 Diabetics in Hillegom', 'orgStudyIdInfo': {'id': 'P9607'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention A: Diet', 'description': 'Intervention A: One week of very low calorie diet, 12 weeks of low calorie diet; exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen).', 'interventionNames': ['Behavioral: Intervention A: Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention B: Exercise', 'description': 'Intervention B: Combination of strength and endurance training, 3 x per week 60 minutes according to the Exercise Program Diabetes (Beweegprogramma Diabetes).\n\nHealthy isocaloric diet.', 'interventionNames': ['Behavioral: Intervention B: Exercise']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention C: Diet and Exercise', 'description': 'Intervention C: one week very low calorie diet, followed by 12 weeks healthy isocaloric diet.\n\nOne week exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen) followed by 12 weeks strength and endurance training (3 x per week 60 minutes) according to the Exercise Program Diabetes (Beweegprogramma Diabetes)', 'interventionNames': ['Behavioral: Intervention C: Diet and Exercise']}, {'type': 'NO_INTERVENTION', 'label': 'Control - Historical data', 'description': 'Historical data from the GPs Information System from 60 newly diagnosed type 2 diabetes patients in the last five years will be used as control.'}], 'interventions': [{'name': 'Intervention A: Diet', 'type': 'BEHAVIORAL', 'otherNames': ['very low calorie diet based on Modifast meal replacers.'], 'description': 'subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice', 'armGroupLabels': ['Intervention A: Diet']}, {'name': 'Intervention B: Exercise', 'type': 'BEHAVIORAL', 'description': 'subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.', 'armGroupLabels': ['Intervention B: Exercise']}, {'name': 'Intervention C: Diet and Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['very low calorie diet based on Modifast meal replacers.'], 'description': 'subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.', 'armGroupLabels': ['Intervention C: Diet and Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2181 EK', 'city': 'Hillegom', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Huisartsenpraktijk Lommelaars', 'geoPoint': {'lat': 52.29083, 'lon': 4.58333}}, {'zip': '2181 EN', 'city': 'Hillegom', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Huisartspraktijk C.C. Dekker', 'geoPoint': {'lat': 52.29083, 'lon': 4.58333}}, {'zip': '2181 EN', 'city': 'Hillegom', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Huisartspraktijk Tubbergen', 'geoPoint': {'lat': 52.29083, 'lon': 4.58333}}, {'zip': '2182 AA', 'city': 'Hillegom', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Huisartsenpraktijk Sixlaan 9', 'geoPoint': {'lat': 52.29083, 'lon': 4.58333}}, {'zip': '2182 CA', 'city': 'Hillegom', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Huisartsenpraktijk J.G. van Dusseldorp', 'geoPoint': {'lat': 52.29083, 'lon': 4.58333}}, {'zip': '2182 GP', 'city': 'Hillegom', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Huisartsenpraktijk van der Kaaden', 'geoPoint': {'lat': 52.29083, 'lon': 4.58333}}, {'zip': '2182 LN', 'city': 'Hillegom', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Huisartsenpraktijk Elsbroek', 'geoPoint': {'lat': 52.29083, 'lon': 4.58333}}, {'zip': '2182 VT', 'city': 'Hillegom', 'state': 'South Holland', 'country': 'Netherlands', 'facility': 'Huisartsenpraktijk Mulders', 'geoPoint': {'lat': 52.29083, 'lon': 4.58333}}, {'zip': '3704 HE', 'city': 'Zeist', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'Netherlands Organisation for Applied Scientific Research (TNO)', 'geoPoint': {'lat': 52.09, 'lon': 5.23333}}], 'overallOfficials': [{'name': 'Wilrike Pasman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO)'}, {'name': 'Peter van Dijken, Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Netherlands Organisation for Applied Scientific Research (TNO)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.J. Pasman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'W.J. Pasman', 'investigatorAffiliation': 'TNO'}}}}