Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-03-20 @ 6:30 AM
Study NCT ID:
NCT04186767
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2019-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Loss Impact on Male Fertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, unicentre, single group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-26', 'studyFirstSubmitDate': '2019-04-21', 'studyFirstSubmitQcDate': '2019-12-02', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seminal evaluation', 'timeFrame': 'Six months', 'description': 'Spermatic counting will be combined to report'}, {'measure': 'Seminal evaluation', 'timeFrame': 'Six months', 'description': 'Spermatic motility will be combined to report'}, {'measure': 'Seminal evaluation', 'timeFrame': 'Six months', 'description': 'DNA fragmentation will be combined to report'}], 'secondaryOutcomes': [{'measure': 'Metabolic response', 'timeFrame': 'Six months', 'description': 'To evaluate the metabolic parameters lipid and glycemic profiles before and after intervention.'}, {'measure': 'Hormonal measurements', 'timeFrame': 'Six months', 'description': 'To evaluate hormonal parameters total testosterone, LH, FSH, insulin before and after intervention.'}, {'measure': 'Inflamatory response', 'timeFrame': 'Six months', 'description': 'To evaluate cytokines TNFa and IL-6 response before and after intervention.'}, {'measure': 'Adipose tissue evaluation', 'timeFrame': 'Six months', 'description': 'To evaluate adipokines: leptin, adiponectin, UCP-1, FGF21, irisin and PGC1a measures before and after intervention.'}, {'measure': 'Microbiota evaluation', 'timeFrame': 'Six months', 'description': 'Evaluate the whole intestinal metagenomics before and after the intervention'}, {'measure': 'Epigenetic evaluation', 'timeFrame': 'Six months', 'description': 'To evaluate the epigenetic methylation profile of spermatozoa before and after the intervention'}, {'measure': 'Body composition changes', 'timeFrame': 'Six months', 'description': 'Apply body composition digital analyser pre and post intervention.'}, {'measure': 'Brow tissue study', 'timeFrame': 'Six months', 'description': 'Thermodynamic evaluation of brown adipose tissue using infrared thermography.'}, {'measure': 'Adipose tissue toxins study', 'timeFrame': 'Six months', 'description': 'Persistent organic pollutants measure: 2,3,7,8- tetrachlorodibenzo-p-dioxin (TCDD)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Sub Fertility, Male', 'Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI\\> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Patients selected at the endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK) for 6 months, being reassessed clinically and laboratorially monthly.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nObesity in male patients\n\n* Metabolic Syndrome (NCEP-ATP III)\n* Alteration of some of the seminal parameters evaluated in conventional seminal analysis\n\nExclusion Criteria:\n\n* Other causes of hypogonadotrophic hypogonadism\n\n * Hypergonadotrophic hypogonadism\n * Contraindications for performance of ketogenic diet:\n * Type 1 or type 2 diabetes mellitus in insulin use\n * Food drive\n * Alcoholism or drug addiction\n * Severe psychiatric illness\n * Use of coumarin anticoagulants\n * Hepatic insufficiency\n * Severe renal impairment\n * Hematologic diseases\n * Cancer in activity,\n * Cardiovascular or cerebrovascular diseases (arrhythmias, recent myocardial infarction, unstable angina, decompensated heart failure, recent stroke)\n * Gout\n * Renal or biliary lithiasis\n * Major depression or other serious psychiatric illness.'}, 'identificationModule': {'nctId': 'NCT04186767', 'briefTitle': 'Weight Loss Impact on Male Fertility', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Significative Weight Loss Impact on Oxidative Stress, Metabolic, Hormonal, Inflammatory and Seminal Parameters of Obese Men.', 'orgStudyIdInfo': {'id': '86158918.4.0000.0068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weight loss', 'interventionNames': ['Dietary Supplement: Very Low Carb Ketogenic Diet']}], 'interventions': [{'name': 'Very Low Carb Ketogenic Diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients will be submitted to very low-calorie ketogenic dietary intervention (VLCK) according to the recommendations of the Pronokal® Method program including lifestyle and physical activity guidelines. The ketogenic stage (phase 1-3) consists of a VLCD diet (600-800 kcal / d), with low carbohydrate intake and lipids. The amount of high biological value proteins ranges from 0.8 to 1.2 g / kg of body weight / day. This first stage (ketogenic) is maintained until the patient reaches the goal of reducing the target weight by 80% to be reduced, being variable in time, according to the response of each patient. After this period, it evolved to a non-ketogenic stage, initiating the hypocaloric diet (800 to 1500 Kcal), with progressive introduction of other food groups, reducing weight more slowly. The maintenance stage consists of a balanced diet, ranging from 1500 to 2000 Kcal.', 'armGroupLabels': ['Weight loss']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05403000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da Faculdade de Medicina da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alessandra Renck', 'investigatorAffiliation': 'University of Sao Paulo'}}}}