Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-27 @ 4:35 AM
Study NCT ID:
NCT05984459
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-08-02', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes remission', 'timeFrame': '24 months', 'description': 'Measured as HbA1c (%)'}], 'secondaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': '24 months', 'description': 'Measured as kilograms (kg)'}, {'measure': 'Change in body fat', 'timeFrame': '24 months', 'description': 'Measuared in percentage (%)'}, {'measure': 'Change in visceral fat', 'timeFrame': '24 months', 'description': 'Measuared in percentage (%)'}, {'measure': 'Change in waist circumference', 'timeFrame': '24 months', 'description': 'Measured in percentage (%)'}, {'measure': 'Change in Body Mass Index (BMI)', 'timeFrame': '24 months', 'description': 'Measured in kilogram per square meter (kg/m\\^2)'}, {'measure': 'Number of type 2 diabetes remissions', 'timeFrame': '24 months', 'description': 'Measured as count of participants'}, {'measure': 'Decreases in poglycemic drug treatments', 'timeFrame': '24 months', 'description': 'Measured as changes in the number of diabetes treatments'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Very low-calorie ketogenic diet', 'VLCKD', 'Type 2 diabetes', 'Overweight', 'Obesity'], 'conditions': ['Type 2 Diabetes Mellitus', 'Overweight and Obesity']}, 'descriptionModule': {'briefSummary': 'There is a strong correlation between being overweight, specifically with abdominal fat, and type 2 diabetes mellitus (T2DM). Recent scientific literature has highlighted the connection between significant weight loss, specifically 15% or more of body weight, and its positive impact on body composition and glycemic profiles. In this study, the focus is on very low carbohydrate ketogenic diets (VLCKDs) as a nutritional strategy for managing excess weight and improving diabetes. Current research is transforming the understanding of T2DM, demonstrating that effective and timely interventions can lead to diabetes remission, including a partial recovery of insulin secretion and function.\n\nHowever, the daily life of a diabetic patient in a clinical setting may not always mirror that of a patient participating in a study, who receives planned follow-up visits and close supervision. To address this discrepancy, this study aims to analyze a cohort of patient records with T2DM and overweight who have adopted a VLCKD, specifically through the PnK® Method, in a private diabetology practice. The goal is to assess the impact of VLCKD on glycemic control in real-life scenarios.', 'detailedDescription': 'The investigator wishes to carry out an observational, retrospective, uncontrolled, monocentric analysis on a group of patients with overweight and type 2 diabetes mellitus (T2DM).\n\nThe analysis will focus on the observation of the evolution of anthropometric and clinical parameters, such as the improvement or normalization of HbA1c, as well as on the evolution of the hypoglycemic medication.\n\nThe data collected and analyzed will correspond to 4 moments:\n\n1. T0, at the start of treatment.\n2. T1, at the end of VLCKD, period of ketosis with an average duration of 12 weeks.\n3. T2, after 6-9 months of support and individualized therapeutic education for a new lifestyle.\n4. T3, after 18-24 months of usual follow-up with 1 visit every 3 to 6 months.\n\nThe population included in the analysis consists of adults with T2DM, with a BMI greater than 25 kg/m2, followed in a diabetology office. This constitutes a form of selection of the population because people with more social, economic, linguistic difficulties, more complex pathologies will be better taken care of in a hospital environment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A patient cohort with overweight and type 2 diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a diagnosis of type 2 diabetes\n* Being overweight (BMI \\> 25 kg/m\\^2) or obesity (BMI \\> 29.9 kg/m\\^2)\n* Have wished to engage in a weight loss program according to the PnK® method\n* Have accepted and signed the consent for the use of data\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Type 1 diabetes\n* Eating disorders\n* Psychiatric disorders\n* Have any contraindication for doing the active or ketogenic phase'}, 'identificationModule': {'nctId': 'NCT05984459', 'briefTitle': 'Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes', 'organization': {'class': 'OTHER', 'fullName': 'Cabinet Medical'}, 'officialTitle': 'Type 2 Diabetes Treatment and Remission With a Very Low-Calorie Ketogenic Diet (VLCKD) and Lifestyle Changes', 'orgStudyIdInfo': {'id': 'FMH Endocrinol and Diabetol'}}, 'armsInterventionsModule': {'interventions': [{'name': 'VLCKD', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The analysis will focus on the observation of the evolution of anthropometric and clinical parameters,such as the improvement or normalization of HbA1c, as well as on the evolution of the hypoglycemic medication between patients who accept VLCKD method'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1003', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Dr. Daniela Sofra', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cabinet Medical', 'class': 'OTHER'}, 'collaborators': [{'name': 'Trialance SCCL', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}