Type2 Diabetes MellitusNCT07352618
"Effect of Omega-3 Supplementation as Add on Therapy on Glycemic Control and Lipid Profile in Type2 Diabetes Mellitus."
A study testing Omega-3 Fatty Acids in people with Type2 Diabetes Mellitus, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years, men only
- Conditions the study is for
- Type2 Diabetes Mellitus
- What is being tested?
- Omega-3 Fatty Acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 25 years up to 75 years
- Old and newly diagnosed case of Type2 DM.
- Patient receiving conventional diabetic treatment like OAD or insulin or both
- Patient may have altered lipid profile or not
- Both male and female patient
- Patient's HbA1c level within 8.0%
Who cannot join
- Pregnancy and lactating mother.
- History of known Type1 diabetes mellitus, secondary diabetes, drug induced diabetes, drugs interfering body weight.
- Patient with acute illness, liver disease, psychiatric disorder
- Patients receiving Omega-3 supplementation within the last three months.
- Known allergy to fish oil or Omega-3 supplements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "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"
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:
Does 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.
Participants 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.
Read the detailed description
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.
Aim 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.
Methodology: 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.
Pearson 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.
Conclusion: Combining Omega-3 supplementation with the conventional treatment could potentially have a substantial impact on lipid profile and glycemic control in patients with T2DM.
- Conditions
- Type2 Diabetes Mellitus
- Being tested
- Omega-3 Fatty Acids, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDietary supplement
Participants received Omega-3 1gm capsule orally twice daily for 12 weeks
placeboDietary supplement
Participants received Omega-3 placebo capsule twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Omega-3, | Experimental | Participant received Cap Omega-3 1gm orally twice daily for 12 weeks Receives: Dietary Supplement: Omega-3 Fatty Acids |
| Placebo | Placebo comparator | Participants received Omega-3 placebo capsule matching Omega-3 orally twice daily for 12 weeks Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in lipid profile
(triglycerides, HDL-Cholesterol)
Measured: 12 weeks
Change in Plasma Omega-3 level
changes in plasma DHA and EPA conc
Measured: 12 weeks
Change in HbA1c
Measured: 12 weeks
Improvement of Fasting Plasma Glucose
Measured: 12 weeks
Secondary outcomes (1)
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Toufique Tania Prity, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352618
- Sponsor's protocol ID
- BMU/2025/10266
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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"
- ClinicalTrials.gov ID
- NCT07352618
- Acronym / sponsor ID
- BMU/2025/10266
- Conditions
- Type2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Does 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.
Participants 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.
Detailed description
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.
Aim 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.
Methodology: 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.
Pearson 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.
Conclusion: Combining Omega-3 supplementation with the conventional treatment could potentially have a substantial impact on lipid profile and glycemic control in patients with T2DM.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3, | Experimental | Dietary Supplement: Omega-3 Fatty AcidsParticipant received Cap Omega-3 1gm orally twice daily for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: placeboParticipants received Omega-3 placebo capsule matching Omega-3 orally twice daily for 12 weeks |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age above 25 years up to 75 years
- Old and newly diagnosed case of Type2 DM.
- Patient receiving conventional diabetic treatment like OAD or insulin or both
- Patient may have altered lipid profile or not
- Both male and female patient
Key exclusion criteria (5 listed)
- Pregnancy and lactating mother.
- History of known Type1 diabetes mellitus, secondary diabetes, drug induced diabetes, drugs interfering body weight.
- Patient with acute illness, liver disease, psychiatric disorder
- Patients receiving Omega-3 supplementation within the last three months.
- Known allergy to fish oil or Omega-3 supplements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty AcidsParticipants received Omega-3 1gm capsule orally twice daily for 12 weeks | Dietary supplement | Omega-3, |
| placeboParticipants received Omega-3 placebo capsule twice daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Changes in lipid profile
Time frame: 12 weeks
(triglycerides, HDL-Cholesterol)
Change in Plasma Omega-3 level
Time frame: 12 weeks
changes in plasma DHA and EPA conc
Change in HbA1c
Time frame: 12 weeks
Improvement of Fasting Plasma Glucose
Time frame: 12 weeks
1 secondary outcome
Change in Blood Pressure (Systolic and Diastolic Blood Pressure)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
Related trials for Type2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acids in people with Type2 Diabetes Mellitus, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in lipid profile (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.