Omega 3 Fatty Acids on Serum Irisin and Sirtuin-1 in Type 2 Diabetic Mellitus Patients Treated With Glimepiride

NCT03917940 | Completed

• 1 other identifier: omega 3 in diabetics type 2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

study the effect of omega 3 fatty acids on blood glucose, lipids profile, serum Irisin and sirtuin-1 in type 2 diabetic mellitus patients treated with glimepiride.

Conditions

Diabetic Patients

Keywords

Irisin; sirtuin-1; Omega 3 fatty acids

Outcome Measures

Primary Outcomes (2)

• serum Irisin concentration (ng/ml)

  Myokines have anti- inflammatory properties

  three months

• serum sirtuin-1 concentration (ng/ml)

  class III protein deacetylase that is associated with aging, inflammation and CVD

  three months

Secondary Outcomes (1)

• Fasting Blood Sugar

  Three Months

Study Arms (2)

Omega 3 + glimepiride

EXPERIMENTAL

group 1: 35 patients treated with (Omega - 3 1000mg / day oral plus glimepiride 2mg or 3mg /day.

Dietary Supplement: Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral

Control

PLACEBO COMPARATOR

group 2: 35 patients treated with glimepiride 2mg or 3mg /day.

Drug: Glimepiride

Interventions

Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral DIETARY_SUPPLEMENT

Omega 3 fatty acids 1000 mg per day oral

Also known as: Omega three

Omega 3 + glimepiride

Glimepiride DRUG

glimepiride 2 mg or 3 mg per day oral

Also known as: Amaryl

Control

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 30-60 years old with type 2 diabetes mellitus treated with glimepiride.
• glycated hemoglobin percent greater than 7%.
• body mass index between 25 and 35 kg/m2.
• Patients who are not consuming omega-3 fatty acids, supplements or any pharmaceutical products that may interact with their lipid profile.

You may not qualify if:

• Pregnant or lactating women.
• Have gastrointestinal disorders that interfere with the bowel function
• patients with severe hepatic, renal, inflammatory and thyroid diseases.
• insulin therapy.
• Have diabetes complications including micro and macrovascular complications.
• Alcoholics and patients with past history of drug abuse.

Sponsors & Collaborators

• Damanhour University: lead

Study Sites (1)

Damanhour Medical National Institute

Damanhūr, El-Bahairah, 31527, Egypt

Location

Related Publications (3)

• Aghasi M, Ghazi-Zahedi S, Koohdani F, Siassi F, Nasli-Esfahani E, Keshavarz A, Qorbani M, Khoshamal H, Salari-Moghaddam A, Sotoudeh G. The effects of green cardamom supplementation on blood glucose, lipids profile, oxidative stress, sirtuin-1 and irisin in type 2 diabetic patients: a study protocol for a randomized placebo-controlled clinical trial. BMC Complement Altern Med. 2018 Jan 17;18(1):18. doi: 10.1186/s12906-017-2068-6.

  PMID: 29343256 RESULT

• Lluis L, Taltavull N, Munoz-Cortes M, Sanchez-Martos V, Romeu M, Giralt M, Molinar-Toribio E, Torres JL, Perez-Jimenez J, Pazos M, Mendez L, Gallardo JM, Medina I, Nogues MR. Protective effect of the omega-3 polyunsaturated fatty acids: Eicosapentaenoic acid/Docosahexaenoic acid 1:1 ratio on cardiovascular disease risk markers in rats. Lipids Health Dis. 2013 Oct 1;12:140. doi: 10.1186/1476-511X-12-140.

  PMID: 24083393 RESULT

• Werida RH, Ramzy A, Ebrahim YN, Helmy MW. Effect of coadministration of omega-3 fatty acids with glimepiride on glycemic control, lipid profile, irisin, and sirtuin-1 in type 2 diabetes mellitus patients: a randomized controlled trial. BMC Endocr Disord. 2023 Nov 25;23(1):259. doi: 10.1186/s12902-023-01511-2.

  PMID: 38001474 DERIVED

MeSH Terms

Interventions

Fatty Acids, Omega-3; glimepiride

Intervention Hierarchy (Ancestors)

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

Study Officials

• Maged W Helmy, Ass. Prof.

  Pharmacology & Toxicology department- faculty of pharmacy- Damanhour University.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Pharmacy Lecturer

Model Details: The patients will be divided into two groups: group 1 treated with (Omega - 3 and glimepiride, n=35). group 2 treated with glimepiride alone, n=35).

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 17, 2019
• Study Start: January 31, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 10, 2020
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)