Diabetic PatientsNCT03917940
Omega 3 Fatty Acids on Serum Irisin and Sirtuin-1 in Type 2 Diabetic Mellitus Patients Treated With Glimepiride
A study testing Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral and Glimepiride in people with Diabetic Patients, run by Damanhour University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Diabetic Patients
- What is being tested?
- Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral and Glimepiride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2019to 10 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 70 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
- All Participants agreed to take part in this clinical study and provide informed consent.
Methodology
- The study will be conducted in 70 patients who are aged 30-60 years old with type 2 diabetes mellitus for at least 2 years. The patients will be assigned into two groups (Omega - 3/glimepiride, n=35; glimepiride, n=35).
- Serum Irisin, sirtuin-1, Hb A1C, Fasting blood sugar (FBS), Lipid profile, Fasting insulin, HOMA-IR and Atherogenic index of plasma (AIP) will be measured at the beginning and after 12 weeks of intervention.
- Anthro-pometric parameters including Weight and height to calculate body mass index will be measured at the beginning and after intervention.
- past medical history and medication history will be documented.
- Each subject in the test group will receive a total dose of 1000 mg of omega-3 fatty acids per day in the form of three capsules along with a glimepiride tablet to be taken once daily, while each subject in the other group will receive glimepiride tablet to be taken once daily for 12 weeks.
- Venous blood samples will be obtained from patients at the beginning and after 12 weeks of intervention.
- A commercially available enzyme-linked immuno-sorbent assay kits will be used for the measurement of Irisin and sirtuin-1.
- The patients will be advised not to change their usual diet, drug regimen and physical activity levels throughout the study.
- Conditions
- Diabetic Patients
- Being tested
- Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral, Glimepiride
- Keywords
- Irisin, sirtuin-1, Omega 3 fatty acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oralDietary supplement
Also called Omega three
Omega 3 fatty acids 1000 mg per day oral
GlimepirideDrug
Also called Amaryl
glimepiride 2 mg or 3 mg per day oral
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 + glimepiride | Experimental | group 1: 35 patients treated with (Omega - 3 1000mg / day oral plus glimepiride 2mg or 3mg /day. Receives: 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. Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum Irisin concentration (ng/ml)
Myokines have anti- inflammatory properties
Measured: three months
serum sirtuin-1 concentration (ng/ml)
class III protein deacetylase that is associated with aging, inflammation and CVD
Measured: three months
Secondary outcomes (1)
Fasting Blood Sugar
Serum Glucose (mg/dl)
Measured: Three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start31 Jan 2019
- Primary completion1 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic PatientsStudies 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
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Maged W Helmy, Ass. Prof., Study director, Pharmacology & Toxicology department- faculty of pharmacy- Damanhour University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917940
- Sponsor's protocol ID
- omega 3 in diabetics type 2
- Status last verified
- Nov 2023
- First submitted
- 14 Apr 2019
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29343256Lluis 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.
PubMed 24083393Werida 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.
PubMed 38001474
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03917940
- Acronym / sponsor ID
- omega 3 in diabetics type 2
- Conditions
- Diabetic Patients
- Keywords
- Irisin, sirtuin-1, Omega 3 fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 17 Apr 2019 (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.
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.
Detailed description
- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University
- All Participants agreed to take part in this clinical study and provide informed consent.
Methodology
- The study will be conducted in 70 patients who are aged 30-60 years old with type 2 diabetes mellitus for at least 2 years. The patients will be assigned into two groups (Omega - 3/glimepiride, n=35; glimepiride, n=35).
- Serum Irisin, sirtuin-1, Hb A1C, Fasting blood sugar (FBS), Lipid profile, Fasting insulin, HOMA-IR and Atherogenic index of plasma (AIP) will be measured at the beginning and after 12 weeks of intervention.
- Anthro-pometric parameters including Weight and height to calculate body mass index will be measured at the beginning and after intervention.
- past medical history and medication history will be documented.
- Each subject in the test group will receive a total dose of 1000 mg of omega-3 fatty acids per day in the form of three capsules along with a glimepiride tablet to be taken once daily, while each subject in the other group will receive glimepiride tablet to be taken once daily for 12 weeks.
- Venous blood samples will be obtained from patients at the beginning and after 12 weeks of intervention.
- A commercially available enzyme-linked immuno-sorbent assay kits will be used for the measurement of Irisin and sirtuin-1.
- The patients will be advised not to change their usual diet, drug regimen and physical activity levels throughout the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Omega 3 + glimepiride | Experimental | Dietary Supplement: Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oralgroup 1: 35 patients treated with (Omega - 3 1000mg / day oral plus glimepiride 2mg or 3mg /day. |
| Control | Placebo comparator | Drug: Glimepiridegroup 2: 35 patients treated with glimepiride 2mg or 3mg /day. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 70 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.
Key exclusion criteria (6 listed)
- 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.
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 acids 1000 mg per day + glimepiride 2 mg or 3 mg oralAlso: Omega threeOmega 3 fatty acids 1000 mg per day oral | Dietary supplement | Omega 3 + glimepiride |
| GlimepirideAlso: Amarylglimepiride 2 mg or 3 mg per day oral | Drug | Control |
Primary outcome
serum Irisin concentration (ng/ml)
Time frame: three months
Myokines have anti- inflammatory properties
serum sirtuin-1 concentration (ng/ml)
Time frame: three months
class III protein deacetylase that is associated with aging, inflammation and CVD
1 secondary outcome
Fasting Blood Sugar
Time frame: Three Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Results publication: PubMed 29343256Aghasi 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.
- Results publication: PubMed 24083393Lluis 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.
- Derived from this study: PubMed 38001474Werida 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maged W Helmy, Ass. Prof. study director
Pharmacology & Toxicology department- faculty of pharmacy- Damanhour University.
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 1000 mg per day + glimepiride 2 mg or 3 mg oral and Glimepiride in people with Diabetic Patients, run by Damanhour University at 1 site in Egypt.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Nov 2023. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
serum Irisin concentration (ng/ml) (time frame: three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917940, which also lists 3 linked publications.
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 22 Nov 2023.