"Effect of Omega-3 Supplementation as Add on Therapy on Glycemic Control and Lipid Profile in Type2 Diabetes Mellitus."

NCT07352618 | Enrolling By Invitation

• 1 other identifier: BMU/2025/10266
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (4)

• Changes in lipid profile

  (triglycerides, HDL-Cholesterol)

  12 weeks

• Change in Plasma Omega-3 level

  changes in plasma DHA and EPA conc

  12 weeks

• Change in HbA1c

  12 weeks

• Improvement of Fasting Plasma Glucose

  12 weeks

Secondary Outcomes (1)

• Change in Blood Pressure (Systolic and Diastolic Blood Pressure)

  12 weeks

Study Arms (2)

Omega-3,

EXPERIMENTAL

Participant received Cap Omega-3 1gm orally twice daily for 12 weeks

Dietary Supplement: Omega-3 Fatty Acids

Placebo

PLACEBO COMPARATOR

Participants received Omega-3 placebo capsule matching Omega-3 orally twice daily for 12 weeks

Dietary Supplement: placebo

Interventions

placebo DIETARY_SUPPLEMENT

Participants received Omega-3 placebo capsule twice daily for 12 weeks

Placebo

Omega-3 Fatty Acids DIETARY_SUPPLEMENT

Participants received Omega-3 1gm capsule orally twice daily for 12 weeks

Omega-3,

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Bangladesh Medical University

Dhaka, Bangladesh

Location

MeSH Terms

Interventions

Fatty Acids, Omega-3

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 20, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-07

Locations

BA (1)