Diabete Type 2NCT06676683
The Use of Statin in Diabetic Patients Not Known to Have Atherosclerotic Cardiovascular Disease
An observational study of Diabete Type 2, run by Sohag University at 1 site in Egypt.
Trial summary
the use of Statin in diabetic patients and its correlation to the guidelines recommendation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Usage of Statin in diabetic patients
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Use of Statin in diabetic patients and its correlation to the guidelines recommendation.
Who may be able to join
- All diabetic > 18 years.
Who cannot join
- Diabetic Patients with known to have Atherosclerotic cardiovascular disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Usama M Abdelaal, Professor contact
Egypt1 site
Sohag university hospital
Sohag, 82524
Usama M Abdelaal, Professor, 00201065962094
Ahmed M Aly, Assoc. professor, 00201011145537
About this study
Official title: The Use of Statin in Diabetic Patients Not Known to Have Atherosclerotic Cardiovascular Disease in a Low Income Community
the use of Statin in diabetic patients and its correlation to the guidelines recommendation.
Read the detailed description
Type 2 diabetes mellitus (T2DM) is a chronic disease characterized by hyperglycemia due to insulin resistance resulting in vascular complications. It accounts for approximately 75% of all atherosclerosis-related events.
Moreover, 65% of patients with diabetes die from any type of cardiovascular disease or stroke. Currently, lipid-lowering statin therapy is recommended for the primary prevention of atherosclerotic cardiovascular diseases, as well as for secondary prevention in DM patients with established cardiovascular disease.
The cardiovascular effects of statins extend beyond their effects on lipid fractions and include atherosclerotic plaque stabilization, anti-inflammatory effects, inhibition of vascular smooth muscle cell proliferation, inhibition of platelet function, and improved vascular endothelial function.
Diabetes mellitus (DM) increases cardiovascular disease (CVD) incidence and mortality. While guidelines endorse statin use in type 2 DM (T2DM) to mitigate cardiovascular risks and mortality, challenges like statin initiation and prompt treatment adjustments affect patient outcomes.
According to the ADA and ACC/AHA guidelines, moderate-intensity statin and lifestyle modifcations are recommended for all diabetic patients aged 40-75 without contraindication to statin therapy to achieve an LDL goal of less than 100 mg/dL. Furthermore, high-intensity statin therapy is recommended for patients with cardiovascular risk factors or overt cardiovascular disease to achieve the LDL goal of less than 70 mg/day.
Even though statins should be prescribed for diabetic patients (> 40) regardless of their LDL laboratory values, monitoring their LDL is needed because some patients may have high LDL values even though they are using statins. It is imperative to consider this because high LDL values build up fatty deposits in the arteries, which reduce blood flow, leading to an increased risk of heart attack.
For primary prevention, moderate-dose statin therapy is recommended for those aged $40 years although high-intensity therapy should be considered in the context of additional ASCVD risk factors. The evidence is strong for people with diabetes aged 40-75 years, an age-group well represented in statin trials showing benefit. Since cardiovascular risk is enhanced in people with diabetes, as noted above, individuals who also have multiple other coronary risk factors have increased risk, equivalent to that of those with ASCVD. Therefore, current guidelines recommend that in people with diabetes who are at higher cardiovascular risk, especially those with one or more ASCVD risk factors, high intensity statin therapy should be prescribed to reduce LDL cholesterol by $50% from baseline and to target an LDL cholesterol of <70 mg/dL (<1.8 mmol/L) Five categories for reasons for statin nonuse were finalized after manual annotation: statin-associated side effects/contraindication, guideline discordant clinician practice, clinical inertia, statin hesitancy, and nonspecific reasons. In addition to side effects attributed to prior statin use, if statins were avoided based on pre-existing comorbidities (such as liver disease) or perceived contraindications (including pregnancy) without a trial or challenge, these reasons were categorized within the side effects/contraindication category. This was done because of low individual frequencies for some of these reasons and to comply with privacy regulations that prevent the reporting of groups with fewer than 10 patients. Clinicians avoiding statin use based on lipid levels was considered guideline-discordant practice, given that statin indications for diabetes are primarily independent of lipid levels. Deferral of statin decisions to future visits despite their indications was considered clinical inertia. Statin hesitancy was noted when patients expressed a preference to avoid statins despite discussion of their indication. Nonspecific documentation was recorded when statin nonuse was documented without additional explanation.
- Conditions
- Diabete Type 2
- Being tested
- Usage of Statin in diabetic patients
- Keywords
- Statin - diabetic - Atherosclerotic cardiovascular disease
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usage of Statin in diabetic patientsDrug
The use of statin in diabetic patients not known to have Atherosclerotic cardiovascular disease in a low income community
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in lipid profile in response to treatment with statin in diabetc patients
Guidelines endorse statin use in Type 2 Diabetes Mellitus (T2DM) to mitigate cardiovascular risks and mortality.
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 posted6 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Abd El-aziz Hassan Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676683
- Sponsor's protocol ID
- Statin in diabetic patient
- Status last verified
- Nov 2024
- First submitted
- 1 Nov 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Farmer JA. Diabetic dyslipidemia and atherosclerosis: evidence from clinical trials. Curr Diab Rep. 2008 Feb;8(1):71-7. doi: 10.1007/s11892-008-0013-2.
PubMed 18367002de Vries FM, Denig P, Pouwels KB, Postma MJ, Hak E. Primary prevention of major cardiovascular and cerebrovascular events with statins in diabetic patients: a meta-analysis. Drugs. 2012 Dec 24;72(18):2365-73. doi: 10.2165/11638240-000000000-00000.
PubMed 23186103Kurihara O, Thondapu V, Kim HO, Russo M, Sugiyama T, Yamamoto E, Fracassi F, Minami Y, Wang Z, Lee H, Yonetsu T, Jang IK. Comparison of Vascular Response to Statin Therapy in Patients With Versus Without Diabetes Mellitus. Am J Cardiol. 2019 May 15;123(10):1559-1564. doi: 10.1016/j.amjcard.2019.02.020. Epub 2019 Feb 22.
PubMed 30851939Almeida SO, Budoff M. Effect of statins on atherosclerotic plaque. Trends Cardiovasc Med. 2019 Nov;29(8):451-455. doi: 10.1016/j.tcm.2019.01.001. Epub 2019 Jan 7.
PubMed 30642643Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.
PubMed 30879355Addendum. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2021. Diabetes Care 2021;44(Suppl. 1):S125-S150. Diabetes Care. 2021 Sep;44(9):2183-2185. doi: 10.2337/dc21-ad09a. Epub 2021 Jun 16. No abstract available.
PubMed 34135017Ogasawara K, Mashiba S, Hashimoto H, Kojima S, Matsuno S, Takeya M, Uchida K, Yajima J. Low-density lipoprotein (LDL), which includes apolipoprotein A-I (apoAI-LDL) as a novel marker of coronary artery disease. Clin Chim Acta. 2008 Nov;397(1-2):42-7. doi: 10.1016/j.cca.2008.07.014. Epub 2008 Jul 18.
PubMed 18691566Taylor F, Huffman MD, Macedo AF, Moore TH, Burke M, Davey Smith G, Ward K, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD004816. doi: 10.1002/14651858.CD004816.pub5.
PubMed 23440795Carter AA, Gomes T, Camacho X, Juurlink DN, Shah BR, Mamdani MM. Risk of incident diabetes among patients treated with statins: population based study. BMJ. 2013 May 23;346:f2610. doi: 10.1136/bmj.f2610.
PubMed 23704171Jellinger PS, Handelsman Y, Rosenblit PD, Bloomgarden ZT, Fonseca VA, Garber AJ, Grunberger G, Guerin CK, Bell DSH, Mechanick JI, Pessah-Pollack R, Wyne K, Smith D, Brinton EA, Fazio S, Davidson M. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF DYSLIPIDEMIA AND PREVENTION OF CARDIOVASCULAR DISEASE. Endocr Pract. 2017 Apr;23(Suppl 2):1-87. doi: 10.4158/EP171764.APPGL.
PubMed 28437620Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
PubMed 31504418Rodriguez F, Maron DJ, Knowles JW, Virani SS, Lin S, Heidenreich PA. Association Between Intensity of Statin Therapy and Mortality in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Jan 1;2(1):47-54. doi: 10.1001/jamacardio.2016.4052.
PubMed 27829091
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Statin in Diabetic Patients Not Known to Have Atherosclerotic Cardiovascular Disease in a Low Income Community
- ClinicalTrials.gov ID
- NCT06676683
- Acronym / sponsor ID
- Statin in diabetic patient
- Conditions
- Diabete Type 2
- Keywords
- Statin - diabetic - Atherosclerotic cardiovascular disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 6 Nov 2024 (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 use of Statin in diabetic patients and its correlation to the guidelines recommendation.
Detailed description
Type 2 diabetes mellitus (T2DM) is a chronic disease characterized by hyperglycemia due to insulin resistance resulting in vascular complications. It accounts for approximately 75% of all atherosclerosis-related events.
Moreover, 65% of patients with diabetes die from any type of cardiovascular disease or stroke. Currently, lipid-lowering statin therapy is recommended for the primary prevention of atherosclerotic cardiovascular diseases, as well as for secondary prevention in DM patients with established cardiovascular disease.
The cardiovascular effects of statins extend beyond their effects on lipid fractions and include atherosclerotic plaque stabilization, anti-inflammatory effects, inhibition of vascular smooth muscle cell proliferation, inhibition of platelet function, and improved vascular endothelial function.
Diabetes mellitus (DM) increases cardiovascular disease (CVD) incidence and mortality. While guidelines endorse statin use in type 2 DM (T2DM) to mitigate cardiovascular risks and mortality, challenges like statin initiation and prompt treatment adjustments affect patient outcomes.
According to the ADA and ACC/AHA guidelines, moderate-intensity statin and lifestyle modifcations are recommended for all diabetic patients aged 40-75 without contraindication to statin therapy to achieve an LDL goal of less than 100 mg/dL. Furthermore, high-intensity statin therapy is recommended for patients with cardiovascular risk factors or overt cardiovascular disease to achieve the LDL goal of less than 70 mg/day.
Even though statins should be prescribed for diabetic patients (> 40) regardless of their LDL laboratory values, monitoring their LDL is needed because some patients may have high LDL values even though they are using statins. It is imperative to consider this because high LDL values build up fatty deposits in the arteries, which reduce blood flow, leading to an increased risk of heart attack.
For primary prevention, moderate-dose statin therapy is recommended for those aged $40 years although high-intensity therapy should be considered in the context of additional ASCVD risk factors. The evidence is strong for people with diabetes aged 40-75 years, an age-group well represented in statin trials showing benefit. Since cardiovascular risk is enhanced in people with diabetes, as noted above, individuals who also have multiple other coronary risk factors have increased risk, equivalent to that of those with ASCVD. Therefore, current guidelines recommend that in people with diabetes who are at higher cardiovascular risk, especially those with one or more ASCVD risk factors, high intensity statin therapy should be prescribed to reduce LDL cholesterol by $50% from baseline and to target an LDL cholesterol of <70 mg/dL (<1.8 mmol/L) Five categories for reasons for statin nonuse were finalized after manual annotation: statin-associated side effects/contraindication, guideline discordant clinician practice, clinical inertia, statin hesitancy, and nonspecific reasons. In addition to side effects attributed to prior statin use, if statins were avoided based on pre-existing comorbidities (such as liver disease) or perceived contraindications (including pregnancy) without a trial or challenge, these reasons were categorized within the side effects/contraindication category. This was done because of low individual frequencies for some of these reasons and to comply with privacy regulations that prevent the reporting of groups with fewer than 10 patients. Clinicians avoiding statin use based on lipid levels was considered guideline-discordant practice, given that statin indications for diabetes are primarily independent of lipid levels. Deferral of statin decisions to future visits despite their indications was considered clinical inertia. Statin hesitancy was noted when patients expressed a preference to avoid statins despite discussion of their indication. Nonspecific documentation was recorded when statin nonuse was documented without additional explanation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Use of Statin in diabetic patients and its correlation to the guidelines recommendation.
Key inclusion criteria (1 listed)
- All diabetic > 18 years.
Key exclusion criteria (1 listed)
- Diabetic Patients with known to have Atherosclerotic cardiovascular disease.
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 |
|---|---|---|
| Usage of Statin in diabetic patientsThe use of statin in diabetic patients not known to have Atherosclerotic cardiovascular disease in a low income community | Drug | – |
Primary outcome
changes in lipid profile in response to treatment with statin in diabetc patients
Time frame: 12 Weeks
Guidelines endorse statin use in Type 2 Diabetes Mellitus (T2DM) to mitigate cardiovascular risks and mortality.
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 6 Nov 2024.
- Background: PubMed 18367002Farmer JA. Diabetic dyslipidemia and atherosclerosis: evidence from clinical trials. Curr Diab Rep. 2008 Feb;8(1):71-7. doi: 10.1007/s11892-008-0013-2.
- Background: PubMed 23186103de Vries FM, Denig P, Pouwels KB, Postma MJ, Hak E. Primary prevention of major cardiovascular and cerebrovascular events with statins in diabetic patients: a meta-analysis. Drugs. 2012 Dec 24;72(18):2365-73. doi: 10.2165/11638240-000000000-00000.
- Background: PubMed 30851939Kurihara O, Thondapu V, Kim HO, Russo M, Sugiyama T, Yamamoto E, Fracassi F, Minami Y, Wang Z, Lee H, Yonetsu T, Jang IK. Comparison of Vascular Response to Statin Therapy in Patients With Versus Without Diabetes Mellitus. Am J Cardiol. 2019 May 15;123(10):1559-1564. doi: 10.1016/j.amjcard.2019.02.020. Epub 2019 Feb 22.
- Background: PubMed 30642643Almeida SO, Budoff M. Effect of statins on atherosclerotic plaque. Trends Cardiovasc Med. 2019 Nov;29(8):451-455. doi: 10.1016/j.tcm.2019.01.001. Epub 2019 Jan 7.
- Background: PubMed 30879355Arnett DK, Blumenthal RS, Albert MA, Buroker AB, Goldberger ZD, Hahn EJ, Himmelfarb CD, Khera A, Lloyd-Jones D, McEvoy JW, Michos ED, Miedema MD, Munoz D, Smith SC Jr, Virani SS, Williams KA Sr, Yeboah J, Ziaeian B. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678. Epub 2019 Mar 17. No abstract available.
- Background: PubMed 34135017Addendum. 10. Cardiovascular Disease and Risk Management: Standards of Medical Care in Diabetes-2021. Diabetes Care 2021;44(Suppl. 1):S125-S150. Diabetes Care. 2021 Sep;44(9):2183-2185. doi: 10.2337/dc21-ad09a. Epub 2021 Jun 16. No abstract available.
- Background: PubMed 18691566Ogasawara K, Mashiba S, Hashimoto H, Kojima S, Matsuno S, Takeya M, Uchida K, Yajima J. Low-density lipoprotein (LDL), which includes apolipoprotein A-I (apoAI-LDL) as a novel marker of coronary artery disease. Clin Chim Acta. 2008 Nov;397(1-2):42-7. doi: 10.1016/j.cca.2008.07.014. Epub 2008 Jul 18.
- Background: PubMed 23440795Taylor F, Huffman MD, Macedo AF, Moore TH, Burke M, Davey Smith G, Ward K, Ebrahim S. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD004816. doi: 10.1002/14651858.CD004816.pub5.
- Background: PubMed 23704171Carter AA, Gomes T, Camacho X, Juurlink DN, Shah BR, Mamdani MM. Risk of incident diabetes among patients treated with statins: population based study. BMJ. 2013 May 23;346:f2610. doi: 10.1136/bmj.f2610.
- Background: PubMed 28437620Jellinger PS, Handelsman Y, Rosenblit PD, Bloomgarden ZT, Fonseca VA, Garber AJ, Grunberger G, Guerin CK, Bell DSH, Mechanick JI, Pessah-Pollack R, Wyne K, Smith D, Brinton EA, Fazio S, Davidson M. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY GUIDELINES FOR MANAGEMENT OF DYSLIPIDEMIA AND PREVENTION OF CARDIOVASCULAR DISEASE. Endocr Pract. 2017 Apr;23(Suppl 2):1-87. doi: 10.4158/EP171764.APPGL.
- Background: PubMed 31504418Mach F, Baigent C, Catapano AL, Koskinas KC, Casula M, Badimon L, Chapman MJ, De Backer GG, Delgado V, Ference BA, Graham IM, Halliday A, Landmesser U, Mihaylova B, Pedersen TR, Riccardi G, Richter DJ, Sabatine MS, Taskinen MR, Tokgozoglu L, Wiklund O; ESC Scientific Document Group. 2019 ESC/EAS Guidelines for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020 Jan 1;41(1):111-188. doi: 10.1093/eurheartj/ehz455. No abstract available.
- Background: PubMed 27829091Rodriguez F, Maron DJ, Knowles JW, Virani SS, Lin S, Heidenreich PA. Association Between Intensity of Statin Therapy and Mortality in Patients With Atherosclerotic Cardiovascular Disease. JAMA Cardiol. 2017 Jan 1;2(1):47-54. doi: 10.1001/jamacardio.2016.4052.
- Individual participant dataSharing planned: Undecided
Related trials for Diabete Type 2
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.
Usama M Abdelaal, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 2, run by Sohag 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 6 Nov 2024. 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. 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?
Contact Islam A Hassan, Master (00201033799510, islam_abdelaziz_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in lipid profile in response to treatment with statin in diabetc patients (time frame: 12 Weeks). 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 NCT06676683, which also lists 12 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 6 Nov 2024.