Diabetes MellitusType 1Phase 3NCT05679037
Role of Alpha-lipoic Acid in Diabetes Melitus Type 1
A Phase 3 study testing Alpha Lipoic Acid 600 MG Oral Capsule in people with Diabetes MellitusType 1, run by Tanta University.
Trial summary
This study aims at investigating the possible effect of alpha-lipoic acid on endothelial dysfunction and atherosclerosis in children with type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Diabetes MellitusType 1
- What is being tested?
- Alpha Lipoic Acid 600 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Nov 2024
- Phase
- Phase 3
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with T1DM on insulin therapy ≥ 0.5 IU/kg/day.
- Age range between 12 and < 18 years old.
- Both sex.
- Duration of diabetes ≥ 3 years.
- Glycated hemoglobin of ≥ 7.5%
- Patients who are previously evaluated for endothelial dysfunction and atherosclerosis.
Who cannot join
- Clinical evidence of heart failure, coronary artery disease, systemic hypertension, rheumatic fever, cardiomyopathy.
- Concurrent use of any medication other than insulin known to affect cardiac function (such as digitalis, angiotensin converting enzyme inhibitor, or β-blocker, etc…).
- Concurrent use of hyperlipidemia agents (Statin, fibrate).
- Concurrent use of antioxidants as selenium, vitamin C, vitamin E, etc..
- Patients with inflammatory conditions.
- Patients with conditions predispose to oxidative stress (obesity, COPD, etc…).
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- Patients with liver disease.
- Patients with thyroid disease.
- Patients with seizures.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Possible Role of Alpha-Lipoic Acid in Improving Endothelial Dysfunction and Atherosclerosis in Children With Type 1 Diabetes Mellitus
This study aims at investigating the possible effect of alpha-lipoic acid on endothelial dysfunction and atherosclerosis in children with type 1 diabetes mellitus.
Read the detailed description
Endothelial dysfunction and alterations in vascular structure are early indicators of future cardiovascular events. The atherosclerotic changes begin much earlier than the appearance of clinical disease. Endothelial dysfunction in diabetes may be the result of a combination of multiple stressors. In the patients with type 1 diabetes, a significant increase in the concentrations of endothelial markers was already observed at the early stages of the disease including vascular cell adhesion molecules (VCAM-1), intercellular adhesion molecules (sICAM-1), soluble E- selectin E (sE-Selektin), asymmetric dimethylarginine (ADMA), plasminogen activator inhibitor 1 (PAI-1) because their concentrations increase rapidly in states of cellular stress. Increased carotid intima-media thickness (CIMT) is a structural marker for early atherosclerosis that correlates with cardio-vascular risk factors.
Alpha -lipoic acid supplementation may have role in Improving Endothelial Dysfunction and early Atherosclerosis due to its oxidative and anti-inflammatory effect.
- Conditions
- Diabetes MellitusType 1
- Being tested
- Placebo, Alpha Lipoic Acid 600 MG Oral Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Inactive capsules
Alpha Lipoic Acid 600 MG Oral CapsuleDrug
Also called Thioctic acid
Universal antioxidant
| Study group | Role | What they receive |
|---|---|---|
| Placebo group who received insulin only plus placebo tablets | Placebo comparator | (Placebo group; n=22) which will receive insulin plus placebo tablets once daily for 6 months. Receives: Other: Placebo |
| ALA group who received Alpha lipoic acid plus insulin | Active comparator | (alpha-lipoic acid group; n=22) which will receive insulin plus ALA 600mg once daily for 6 months. Receives: Drug: Alpha Lipoic Acid 600 MG Oral Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in carotid artery intima-media thickness (CIMT)
Measurement of carotid intima-media thickness (CIMT) which is mainly used to assess subclinical atherosclerosias and its assessment is based on ultrasound transducer
Measured: Baseline and 6 months
Secondary outcomes (7)
The change in serum level of hs-CRP
High sensitivity C- reactive protein (hs-CRP) which will be assessed by ELISA.
Measured: Baseline and 6 months
The change in serum level (MDA)
Malondialdehyde (MDA) which will be assessed by colorimetric method.
Measured: Baseline and 6 months
The change in the serum level of VCAM-1
Vascular cell adhesion molecule-1 (VCAM-1) a marker of endothelial dysfunction which will be assessed by ELISA.
Measured: Baseline and 6 months
The change in the serum level of Apelin
Serum Apelin a marker of atherosclerosis which will be assessed by ELISA
Measured: Baseline and 6 months
Lipid profile measuremt
Total cholesterol (TC), triglyceride (TG) and HDL-C will be assessed by enzymatic colorimetric method.
Measured: Baseline and 6 months
Change in plasma level of (HbA1c %)
Glycated hemoglobin (HbA1c %) will be measured by ion exchange micro-column chromatographic method.
Measured: Baseline and 3,6 months
Fast blood glucose measuremt
Fasting blood glucose will be determined by glucose oxidase method.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study startJan 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusType 1Studies of the same condition, open and under way.
- More trials run by Tanta 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahmed mohamed Attia Harby, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679037
- Sponsor's protocol ID
- Role of ALA in diabetes
- Status last verified
- Jan 2023
- First submitted
- 21 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Role of Alpha-Lipoic Acid in Improving Endothelial Dysfunction and Atherosclerosis in Children With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05679037
- Acronym / sponsor ID
- Role of ALA in diabetes
- Conditions
- Diabetes MellitusType 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 10 Jan 2023 (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.
This study aims at investigating the possible effect of alpha-lipoic acid on endothelial dysfunction and atherosclerosis in children with type 1 diabetes mellitus.
Detailed description
Endothelial dysfunction and alterations in vascular structure are early indicators of future cardiovascular events. The atherosclerotic changes begin much earlier than the appearance of clinical disease. Endothelial dysfunction in diabetes may be the result of a combination of multiple stressors. In the patients with type 1 diabetes, a significant increase in the concentrations of endothelial markers was already observed at the early stages of the disease including vascular cell adhesion molecules (VCAM-1), intercellular adhesion molecules (sICAM-1), soluble E- selectin E (sE-Selektin), asymmetric dimethylarginine (ADMA), plasminogen activator inhibitor 1 (PAI-1) because their concentrations increase rapidly in states of cellular stress. Increased carotid intima-media thickness (CIMT) is a structural marker for early atherosclerosis that correlates with cardio-vascular risk factors.
Alpha -lipoic acid supplementation may have role in Improving Endothelial Dysfunction and early Atherosclerosis due to its oxidative and anti-inflammatory effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group who received insulin only plus placebo tablets | Placebo comparator | Other: Placebo(Placebo group; n=22) which will receive insulin plus placebo tablets once daily for 6 months. |
| ALA group who received Alpha lipoic acid plus insulin | Active comparator | Drug: Alpha Lipoic Acid 600 MG Oral Capsule(alpha-lipoic acid group; n=22) which will receive insulin plus ALA 600mg once daily for 6 months. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children with T1DM on insulin therapy ≥ 0.5 IU/kg/day.
- Age range between 12 and < 18 years old.
- Both sex.
- Duration of diabetes ≥ 3 years.
- Glycated hemoglobin of ≥ 7.5%
Key exclusion criteria (9 listed)
- Clinical evidence of heart failure, coronary artery disease, systemic hypertension, rheumatic fever, cardiomyopathy.
- Concurrent use of any medication other than insulin known to affect cardiac function (such as digitalis, angiotensin converting enzyme inhibitor, or β-blocker, etc…).
- Concurrent use of hyperlipidemia agents (Statin, fibrate).
- Concurrent use of antioxidants as selenium, vitamin C, vitamin E, etc..
- Patients with inflammatory conditions.
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 |
|---|---|---|
| PlaceboInactive capsules | Other | Placebo group who received insulin only plus placebo tablets |
| Alpha Lipoic Acid 600 MG Oral CapsuleAlso: Thioctic acidUniversal antioxidant | Drug | ALA group who received Alpha lipoic acid plus insulin |
Primary outcome
The change in carotid artery intima-media thickness (CIMT)
Time frame: Baseline and 6 months
Measurement of carotid intima-media thickness (CIMT) which is mainly used to assess subclinical atherosclerosias and its assessment is based on ultrasound transducer
7 secondary outcomes
The change in serum level of hs-CRP
Time frame: Baseline and 6 months
The change in serum level (MDA)
Time frame: Baseline and 6 months
The change in the serum level of VCAM-1
Time frame: Baseline and 6 months
The change in the serum level of Apelin
Time frame: Baseline and 6 months
Lipid profile measuremt
Time frame: Baseline and 6 months
Change in plasma level of (HbA1c %)
Time frame: Baseline and 3,6 months
Fast blood glucose measuremt
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha Lipoic Acid 600 MG Oral Capsule in people with Diabetes MellitusType 1, run by Tanta University.
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 9 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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara SA Harby, Master (01128743303, saraharby171@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in carotid artery intima-media thickness (CIMT) (time frame: Baseline and 6 months). 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 10 Jan 2023.