Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-02-25 @ 11:05 PM
Study NCT ID:
NCT05322551
Status:
UNKNOWN
Last Update Posted:
2022-09-01
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood will be collected for serum/plasma during baseline and 6 \\& 12 month follow-up Adipose tissue (omentum, visceral) will be collected during surgery. Venous blood samples (20mL = 4 teaspoons) will be collected prior to surgery, 6 month and 1 year postoperatively. The plasma samples will be obtained by centrifugation at 800 g for 15 min, and the aliquots will be transferred to polypropylene tubes and stored at -80°C until they are assayed. Total RNA and miRNA will be isolated according to manufacturer instructions.\n\nThe first morning urine samples (minimum 30mL) will be collected. Frozen tubes will be used and stored at -80 °C until processing for Nuclear Magnetic Resonance (NMR) analysis.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2022-04-03', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body weight changes', 'timeFrame': '6 months', 'description': 'Body weight changes'}, {'measure': 'Body weight changes', 'timeFrame': '12 months', 'description': 'Body weight changes'}, {'measure': 'Body mass index (BMI) changes', 'timeFrame': '6 months', 'description': 'Body mass index changes measured in kg/m\\^2 (weight in kilograms, height in meters)'}, {'measure': 'Body mass index (BMI) changes', 'timeFrame': '12 months', 'description': 'Body mass index changes measured in kg/m\\^2 (weight in kilograms, height in meters)'}, {'measure': 'Body Fat Percentage changes', 'timeFrame': '6 months', 'description': 'Body Fat Percentage changes measured in percentage'}, {'measure': 'Body Fat Percentage changes', 'timeFrame': '12 months', 'description': 'Body Fat Percentage changes measured in percentage'}, {'measure': 'Fasting Blood Glucose changes', 'timeFrame': '6 months', 'description': 'Fasting Blood Glucose changes measured in mmol/L'}, {'measure': 'Fasting Blood Glucose changes', 'timeFrame': '12 months', 'description': 'Fasting Blood Glucose changes measured in mmol/L'}, {'measure': 'HbA1c changes', 'timeFrame': '6 months', 'description': 'HbA1c changes measured in percentage'}, {'measure': 'HbA1c changes', 'timeFrame': '12 months', 'description': 'HbA1c changes measured in percentage'}, {'measure': 'Changes of metabolites profile', 'timeFrame': '6 months', 'description': 'Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)'}, {'measure': 'Changes of metabolites profile', 'timeFrame': '12 months', 'description': 'Changes of serum diabetes-related metabolites using Nuclear Magnetic Resonance (NMR)'}, {'measure': 'Changes in lipid related biochemical parameters', 'timeFrame': '6 months', 'description': 'Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L'}, {'measure': 'Changes in lipid related biochemical parameters', 'timeFrame': '12 months', 'description': 'Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mmol/L'}], 'secondaryOutcomes': [{'measure': 'Quality of Life changes', 'timeFrame': 'At baseline, month 6 and month 12', 'description': 'Quality of Life score measured by Obesity and Weight-Loss Quality of Life (OWLQOL ) questionnaire'}, {'measure': 'Dietary Intake changes', 'timeFrame': 'At baseline, month 6 and month 12', 'description': 'Dietary intake changes measured by Food Frequency Questionnaire (FFQ)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bariatric surgery', 'Metabolic surgery'], 'conditions': ['Obesity; Endocrine', 'Diabete Type 2', 'PreDiabetes']}, 'descriptionModule': {'briefSummary': 'Obesity is a major risk factor for Type 2 Diabetes (T2D) and cardiovascular diseases, such as hypertension and dyslipidemia. Recently, weight loss surgery (i.e., metabolic or bariatric surgery) has been shown to result in very good long-term glycemic control in patients with T2D and obesity. However, knowledge and data on molecular levels and metabolomics are still limited. This study will fill in these gaps and provide potential biomarkers for T2D. Lifestyle and dietary practices (LDP) influence the clinical outcome and metabolites in T2D. Although the roles of LDP is critical in ensuring optimal clinical outcomes, data is still limited especially on relating the LDP and metabolomics in T2D.', 'detailedDescription': 'Study design\n\nThis is a prospective single centre study to explore molecular aspects and metabolomic changes among 102 obese individuals of different diabetes status, undergoing metabolic surgery, which is currently performed in Hospital Kuala Lumpur, Malaysia. Serial measurements of the selected markers will be made pre-operative (baseline), at 6 and 12 months follow up after surgery. Twenty (20) healthy individuals will be recruited as controls.\n\nStudy population\n\nAll subjects with obesity (Body Mass Index ≥ 30kg/m\\^2 \\[WHO classification\\])) and diagnosed with pre-diabetes, T2D and non-diabetic (healthy) who are undergoing metabolic surgery at Hospital Kuala Lumpur will be recruited.\n\nAll patients referred by endocrinologists who are eligible and fulfill the inclusion and exclusion criteria for metabolic surgery will be included in the study until the sample size is achieved. Routinely, all patients will need to pay a visit to the clinic at 1, 2, 4 weeks after surgery, then 3, 6, 9, 12, 18, 24 months and after that, a life-long annual visit. Therefore, visit 6- and 12-month will be utilized for study follow-ups.\n\nMetabolic surgery\n\nThe two most standard metabolic surgical procedures performed at Hospital Kuala Lumpur are laparoscopic sleeve gastrectomy and laparoscopic Roux en Y gastric bypass (RYGB). All the procedures are performed laparoscopically using 5-ports technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects with obesity (Body Mass Index ≥ 30kg/m2 \\[WHO classification\\])) and diagnosed with pre-diabetes, T2D and non-diabetic (healthy) who are undergoing metabolic surgery at Hospital Kuala Lumpur will be recruited. Healthy individuals will be recruited as controls for reference range', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients' Inclusion Criteria\n\n* BMI \\> 30kg/m2\n* Men and women\n* Ages 18-65 years old\n* Diabetes status (non diabetic, pre diabetes and diabetes)\n* Patients who will undergo metabolic surgery\n\nHealthy individuals' Inclusion Criteria\n\n* BMI \\< 30kg/m2,\n* Men and women\n* Ages 18-65 years old\n* No diabetes\n* No pre diabetes\n* No other co-morbidities (high total cholesterol, high triglycerides, high blood pressure)\n\nExclusion Criteria:\n\nPatients' Exclusion Criteria\n\n* BMI \\<30 kg/m2\n* Use of medications that may affect body weight at screening or during a 3 month period prior\n* Other medical conditions like Cushing's, acromegaly, Heart failure, Crohn's disease, etc\n* Alcohol dependence\n\nHealthy Individuals' Exclusion Criteria\n\n* BMI \\> 30 kg/m2 (obese)\n* BMI \\< 18.5 kg/m2 (underweight)\n* Diabetes status (pre diabetes and diabetes)\n* Use of medications that may affect body weight at screening or during a 3 month period prior\n* Other co-morbidities (high total cholesterol, high triglycerides, high blood pressure, cancer)\n* Other medical conditions like Cushing's, acromegaly, Heart failure, Crohn's disease, etc\n* Alcohol dependence"}, 'identificationModule': {'nctId': 'NCT05322551', 'acronym': 'MoMen', 'briefTitle': 'Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health, Malaysia'}, 'officialTitle': 'Molecular, Metabolomic and Nutritional Changes After Metabolic Surgery Among Obese Diabetic Patients and Biomarkers of Different Diabetes Status.', 'orgStudyIdInfo': {'id': 'NMRR-20-2496-56353'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese only', 'description': 'Definition of Obese:\n\nBody Mass Index ≥ 30kg/m\\^2 (WHO classification)\n\nDefinition of Non Diabetes: Fasting Plasma Glucose (FPG) \\< FPG 100 mg/dL (5.6 mmol/L)'}, {'label': 'Obese with prediabetes', 'description': 'Definition of Obese:\n\nBody Mass Index ≥ 30kg/m\\^2 (WHO classification)\n\nDefinition of Prediabetes: FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) OR A1C 5.7-6.4% (39-47 mmol/mol)'}, {'label': 'Obese with diabetes', 'description': 'Definition of Obese:\n\nBody Mass Index ≥ 30kg/m\\^2 (WHO classification)\n\nDefinition of Diabetes: (American Diabetes Association, 2020) FPG ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 h.\\* OR A1C ≥6.5% (48 mmol/mol).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40170', 'city': 'Shah Alam', 'state': 'Selangor', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Fazliana Mansor, PhD', 'role': 'CONTACT', 'email': 'nanamansor@yahoo.com', 'phone': '0162280081'}], 'facility': 'Institute for Medical Research, National Institutes of Health', 'geoPoint': {'lat': 3.08507, 'lon': 101.53281}}], 'centralContacts': [{'name': 'Fazliana Mansor, PhD', 'role': 'CONTACT', 'email': 'fazliana.m@moh.gov.my', 'phone': '+60162280081'}], 'overallOfficials': [{'name': 'Fazliana Mansor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Medical Research, Setia Alam, Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health, Malaysia', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Universiti Putra Malaysia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Officer', 'investigatorFullName': 'Fazliana Mansor', 'investigatorAffiliation': 'Ministry of Health, Malaysia'}}}}