Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT05990205
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2023-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the SCL16A11 Risk Haplotype on Treatments to Prevent Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], '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': 'D008687', 'term': 'Metformin'}, {'id': 'D000081982', 'term': 'Laser Speckle Contrast Imaging'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 437}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-23', 'studyFirstSubmitDate': '2023-07-18', 'studyFirstSubmitQcDate': '2023-08-10', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weigth loss', 'timeFrame': '12 weeks', 'description': 'Number of participants in each treatment arm reaching the the goal weight loss \\>3%'}], 'secondaryOutcomes': [{'measure': 'Change in Total-Cholesterol parameters', 'timeFrame': '12 weeks', 'description': 'Decreasing concentration of Total-Cholesterol (mg/dl)'}, {'measure': 'Change in LDL-Cholesterol parameters', 'timeFrame': '12 weeks', 'description': 'Decreasing LDL-Cholesterol levels (mg/dl)'}, {'measure': 'Change in ApoB', 'timeFrame': '12 weeks', 'description': 'Decreasing ApoB levels (mg/dl)'}, {'measure': 'Change in NonHDL-Cholesterol', 'timeFrame': '12 weeks', 'description': 'Decreasin NonHDL-Cholesterol levels (mg/dl)'}, {'measure': 'Change in fasting glucose', 'timeFrame': '12 weeks', 'description': 'Decreasing fasting glucose levels (mg/dl)'}, {'measure': 'Change in HbA1c', 'timeFrame': '12 weeks', 'description': 'Decreasin HbA1c levels (%)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PreDiabetes', 'Metformin', 'Precision nutrition', 'SLC16A11', 'Mexican Mestizos'], 'conditions': ['PreDiabetes']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized clinical trial is to determine the impact of the risk haplotype on SLC16A11 on early therapeutic responses in treatments to prevent T2D in Mexican mestizos with prediabetes. The main question\\[s\\] it aims to answer are:\n\n* Evaluate the effect of the risk haplotype on weigth loss \\>3%\n* Evualuate the differences in lipid profiles and glycemic parameters (fasting glucose, HbA1c).\n\nParticipants will be randomized into two groups: lifestyle intervention (LSI): hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\\>150 min medium intensity per week), or LSI + MET (750 mg metformin twice a day).\n\nResearchers will compare carriers and non carriers of the risk haplotype of SLC16A11 to see if there are diferent treatment responses.', 'detailedDescription': 'Objectives: Dietary modification and/or metformin remain the most cost-effective treatment to prevent type 2 diabetes (T2D). Yet, there is an important variation in receiving the benefit among individuals. A haplotype in SLC16A11 is associated with decreased insulin action and risk for T2D in Mexicans. We aim to determine the impact of the risk haplotype on SLC16A11 on early therapeutic responses in treatments to prevent T2D.\n\nMethods: We recrute individuals with at least one prediabetes criteria according to the American Diabetes Association with a body mass index (BMI) between 25 and 45 kg/m2. Participants are randomized into two groups: lifestyle intervention (LSI): hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\\>150 min medium intensity per week), or LSI + MET (750 mg metformin twice a day). Standardized dietitians delivere the LSI. The treatment goal is to achieve \\>3% weight loss during the 12-week follow-up. Participants are genotyped for the risk allele rs13342232 and rs75493593. The effects of the risk haplotype are evaluated with linear and logistic regressions adjusted by age, sex, five genetic principal components, BMI, and prediabetes criteria at baseline. Primary outcome is a significant interaction between the treatment arm and genotype in weight loss goal \\>3% after the treatment. Secondary outcome are differences in lipid levels and third outcome is differences in glycemic parameters (fasting glucose, HbA1c).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mexican mestizos\n* At least one prediabetes criteria according to the American Diabetes Association: fasting glucose between 100-124 mg/dL, Glycosylated hemoglobin (HbA1c) between 5.7-6.4, and 2-hour blood sugar between 140 mg/dl-199 mg/dl after an oral load of 75g of glucose) (1);\n* Age ranged between 18-65 years\n* Overweight or obesity (BMI between 25.0 - 40 kg/m2).\n\nExclusion Criteria:\n\n* Chronic diseases\n* Pregnancy\n* Chronic use of medications that altered plasma glucose levels.'}, 'identificationModule': {'nctId': 'NCT05990205', 'acronym': 'PRED2', 'briefTitle': 'Effect of the SCL16A11 Risk Haplotype on Treatments to Prevent Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}, 'officialTitle': 'Effect of the Genetic Variants Typical of the Mestizo Population That Confer Risk of Having Metabolic Diseases on the Response to Common Treatments (Diet, Physical Activity, Metformin, Exercise).', 'orgStudyIdInfo': {'id': '2579'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Life Style Intervention', 'description': 'Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\\>150 min medium intensity per week)', 'interventionNames': ['Behavioral: Life Style Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Life Style Intervention + Metformin', 'description': 'Hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\\>150 min medium intensity per week) + (750 mg metformin twice a day).', 'interventionNames': ['Drug: Life Style Intervention + Metformin']}], 'interventions': [{'name': 'Life Style Intervention + Metformin', 'type': 'DRUG', 'otherNames': ['LSI + MET'], 'description': 'hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\\>150 min medium intensity per week) + Metformin extended release 750mg each 12 hours', 'armGroupLabels': ['Life Style Intervention + Metformin']}, {'name': 'Life Style Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['LSI'], 'description': 'hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\\>150 min medium intensity per week)', 'armGroupLabels': ['Life Style Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Carlos A Aguilar Salinas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be made available to the broader scientific community within six months of publication or within 18 months of the conclusion of the funding period if the study remains unpublished.', 'ipdSharing': 'YES', 'description': 'De-identified data will be shared upon request to authorized researchers', 'accessCriteria': 'Per International standards, we will require from any investigator or entity requesting the data a data-sharing agreement that provides (1) a commitment to using the data only for research purposes and not to identify any individual participants, (2) a commitment to securing the data using appropriate computer technology, and (3) a commitment to destroying or returning the data after analyses are completed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}