Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT04830995
Status:
COMPLETED
Last Update Posted:
2023-01-19
First Post:
2021-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Sensitivity Response to High-Intensity Training in Insulin Resistance During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Randomization was done by sealed envelope'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'group (A) received HIIT and low diet for four weeks, 3 sessions weekly. While the control group received diet only.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-18', 'studyFirstSubmitDate': '2021-04-01', 'studyFirstSubmitQcDate': '2021-04-01', 'lastUpdatePostDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting blood glucose level', 'timeFrame': 'three months', 'description': 'Fasting blood glucose level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.'}], 'secondaryOutcomes': [{'measure': 'Fasting Insulin Level', 'timeFrame': 'three months', 'description': 'Fasting blood insulin level were measured by expert specialist before and after intervention period from 24th to 37th weeks of pregnancy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Training', 'Insulin Resistance', 'Pregnancy'], 'conditions': ['High Intensity Interval Training', 'Diet, Healthy']}, 'descriptionModule': {'briefSummary': 'Insulin Resistance is one of the common complications that occur during pregnancy. Early intervention is essential to prevent the development of the diseaseThere is evidence that physical inactivity increases the risk of a lot of adverse health problems, including coronary heart disease, type 2 diabetes, breast and colon cancers. It also shortens life expectancy. Pregnancy is a period in the life of women that is often associated with decreased daily physical activity and decreased participation in sports and exercise . In the first few weeks of pregnancy, maternal carbohydrate metabolism is affected by a rise in maternal levels of estrogen and progesterone that stimulates pancreatic β-cell hyperplasia and insulin secretion. As pregnancy progress, pancreatic islet cell hypertrophy continues and there is an increased insulin response to glucose or meal stimulation.', 'detailedDescription': 'This study was carried out upon twenty multigravida pregnant female between 5-6 months gestation with IR calculated by HOMA test (fasting blood glucose× fasting insulin) ÷ 22.5. Fasting blood glucose was assessed by the method approved by (7, 13) .The test materials for this method were supplied as kits by "Diamond Diagnostics," while Insulin concentrations were stated in formerly frozen and defrosted serum samples by enzyme immunoassay using the human Insulin ELISA kits.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* forty multigravida females.\n* their age ranged between 25 to 35 years old.\n* Body mass index (BMI) \\<30kg/ m².\n\nExclusion Criteria:\n\n* females with pelvic pathology as endometriosis.\n* females have irregular menstrual cycles.'}, 'identificationModule': {'nctId': 'NCT04830995', 'briefTitle': 'Insulin Sensitivity Response to High-Intensity Training in Insulin Resistance During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Impact of High-Intensity Interval Training on Insulin Resistance During Pregnancy: A Randomized Control Trial.', 'orgStudyIdInfo': {'id': 'Cairo Un100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'diet program', 'description': 'moderate restricted diet (1800-2000 kcal/day) for four weeks, 3 sessions weekly', 'interventionNames': ['Dietary Supplement: moderate restricted diet (1800-2000 kcal/day) for four weeks']}, {'type': 'EXPERIMENTAL', 'label': 'high intensity interval training', 'description': 'high intensity interval training for four weeks, 3 sessions weekly', 'interventionNames': ['Dietary Supplement: moderate restricted diet (1800-2000 kcal/day) for four weeks']}], 'interventions': [{'name': 'moderate restricted diet (1800-2000 kcal/day) for four weeks', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['high intensity interval training'], 'description': 'high intensity interval training 3 sessions for four weeks', 'armGroupLabels': ['diet program', 'high intensity interval training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12613', 'city': 'Giza', 'country': 'Egypt', 'facility': 'Ghada Elrefaye', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heba mohamed Embaby', 'class': 'UNKNOWN'}, {'name': 'Salwa Elgendy', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "assistant professor Department of Physical Therapy for Women's Health, Faculty of Physical therapy, Cairo University, Egypt", 'investigatorFullName': 'Ghada Ebrahim El Refaye', 'investigatorAffiliation': 'Cairo University'}}}}