Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 5:16 PM
Study NCT ID:
NCT07352618
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-21
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Effect of Omega-3 Supplementation as Add on Therapy on Glycemic Control and Lipid Profile in Type2 Diabetes Mellitus."
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-17', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in lipid profile', 'timeFrame': '12 weeks', 'description': '(triglycerides, HDL-Cholesterol)'}, {'measure': 'Change in Plasma Omega-3 level', 'timeFrame': '12 weeks', 'description': 'changes in plasma DHA and EPA conc'}, {'measure': 'Change in HbA1c', 'timeFrame': '12 weeks'}, {'measure': 'Improvement of Fasting Plasma Glucose', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Blood Pressure (Systolic and Diastolic Blood Pressure)', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if Omega-3 works to control glycemic status, improve lipid profile in Type2 Diabetic patients. It will also learn about the safety of drug Omega-3. The main questions it aims to answer are:\n\nDoes drug Omega-3 control glycemic status, improve lipid profile in Type2 Diabetic patients? What medical problems do participants have when taking drug Omega-3? Researchers will compare Omega-3 to a placebo(a look-alike substance that contains no drug)to see if Omega-3 works to treat Type 2 Diabetic patients.\n\nParticipants will take Omega-3 or a placebo twice daily for 12 weeks. Baseline and 12 weeks after FPG, HbA1c,Serum Lipid profile, Omega-3 level will be monitored.', 'detailedDescription': "Diabetes Mellitus is a common endocrine disorder. T2DM is characterized by polyuria, polydipsia, polyphagia. It affects both men and women. T2DM is strongly associated with impaired insulin sensitivity, insulin resistance, dyslipidaemia, hypertension, and central obesity. Omega-3 polyunsaturated fatty acid has been shown to exert beneficial effect on lipid metabolism and insulin sensitivity.\n\nAim of the study: We aimed to evaluate the effect of Omega-3 supplementation as add on therapy on glycemic control and lipid profile in Type 2 diabetes mellitus patients.\n\nMethodology: This research will be a single center study, utilizing a double-blind, randomized placebo-controlled trial design. A total of 66 men and women, with diagnosed T2DM, age range from 25-75 years will randomly be assigned to receive either Omega-3 supplementation or placebo for 12 weeks. Biochemical and anthropometric measurements, including Fasting plasma glucose, HbA1c, lipid profile, blood pressure, BMI, waist-hip ratio and waist-to-height ratio will be assessed at baseline and post-treatment. Follow-up assessments will be conducted after supplementation for 12 weeks to evaluate the sustainability of biochemical changes. For independent samples; t-test will be utilized to analyze the average differences in metabolic biomarker levels between the group receiving Omega-3 supplements and the group receiving a placebo. The Chi-square test or Fisher's exact test will be employed to compare the percentage of participants may show a significant change in metabolic biomarker in the group that received Omega-3 versus the group that received a placebo.\n\nPearson or Spearman correlation tests will be used to explore any relationships between baseline Omega-3 levels and FPG, HbA1c and lipid profile levels, as well as between the change in Omega-3 levels and the change in FPG, HbA1c and lipid profile levels.\n\nConclusion: Combining Omega-3 supplementation with the conventional treatment could potentially have a substantial impact on lipid profile and glycemic control in patients with T2DM."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age above 25 years up to 75 years\n* Old and newly diagnosed case of Type2 DM.\n* Patient receiving conventional diabetic treatment like OAD or insulin or both\n* Patient may have altered lipid profile or not\n* Both male and female patient\n* Patient's HbA1c level within 8.0%\n\nExclusion Criteria:\n\n* Pregnancy and lactating mother.\n* History of known Type1 diabetes mellitus, secondary diabetes, drug induced diabetes, drugs interfering body weight.\n* Patient with acute illness, liver disease, psychiatric disorder\n* Patients receiving Omega-3 supplementation within the last three months.\n* Known allergy to fish oil or Omega-3 supplements."}, 'identificationModule': {'nctId': 'NCT07352618', 'briefTitle': '"Effect of Omega-3 Supplementation as Add on Therapy on Glycemic Control and Lipid Profile in Type2 Diabetes Mellitus."', 'organization': {'class': 'OTHER', 'fullName': 'Bangladesh Medical University'}, 'officialTitle': '"Effect of Omega-3 Supplementation as Add on Therapy on Glycemic Control and Lipid Profile in Type2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled Trial"', 'orgStudyIdInfo': {'id': 'BMU/2025/10266'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omega-3,', 'description': 'Participant received Cap Omega-3 1gm orally twice daily for 12 weeks', 'interventionNames': ['Dietary Supplement: Omega-3 Fatty Acids']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received Omega-3 placebo capsule matching Omega-3 orally twice daily for 12 weeks', 'interventionNames': ['Dietary Supplement: placebo']}], 'interventions': [{'name': 'Omega-3 Fatty Acids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants received Omega-3 1gm capsule orally twice daily for 12 weeks', 'armGroupLabels': ['Omega-3,']}, {'name': 'placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants received Omega-3 placebo capsule twice daily for 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dhaka', 'country': 'Bangladesh', 'facility': 'Bangladesh Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bangladesh Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident', 'investigatorFullName': 'Dr. Toufique Tania Prity', 'investigatorAffiliation': 'Bangladesh Medical University'}}}}