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Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

Primary Purpose

Diabetes MellitusType 1

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Alpha Lipoic Acid 600 MG Oral Capsule
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes MellitusType 1

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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…). Patients with liver disease. Patients with thyroid disease. Patients with seizures.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Placebo group who received insulin only plus placebo tablets

    ALA group who received Alpha lipoic acid plus insulin

    Arm Description

    (Placebo group; n=22) which will receive insulin plus placebo tablets once daily for 6 months.

    (alpha-lipoic acid group; n=22) which will receive insulin plus ALA 600mg once daily for 6 months.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    The change in serum level of hs-CRP
    High sensitivity C- reactive protein (hs-CRP) which will be assessed by ELISA.
    The change in serum level (MDA)
    Malondialdehyde (MDA) which will be assessed by colorimetric method.
    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.
    The change in the serum level of Apelin
    Serum Apelin a marker of atherosclerosis which will be assessed by ELISA
    Lipid profile measuremt
    Total cholesterol (TC), triglyceride (TG) and HDL-C will be assessed by enzymatic colorimetric method.
    Change in plasma level of (HbA1c %)
    Glycated hemoglobin (HbA1c %) will be measured by ion exchange micro-column chromatographic method.
    Fast blood glucose measuremt
    Fasting blood glucose will be determined by glucose oxidase method.

    Full Information

    First Posted
    December 21, 2022
    Last Updated
    January 8, 2023
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05679037
    Brief Title
    Role of Alpha-lipoic Acid in Diabetes Melitus Type 1
    Official Title
    The Possible Role of Alpha-Lipoic Acid in Improving Endothelial Dysfunction and Atherosclerosis in Children With Type 1 Diabetes Mellitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    November 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes MellitusType 1

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo group who received insulin only plus placebo tablets
    Arm Type
    Placebo Comparator
    Arm Description
    (Placebo group; n=22) which will receive insulin plus placebo tablets once daily for 6 months.
    Arm Title
    ALA group who received Alpha lipoic acid plus insulin
    Arm Type
    Active Comparator
    Arm Description
    (alpha-lipoic acid group; n=22) which will receive insulin plus ALA 600mg once daily for 6 months.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Inactive capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Alpha Lipoic Acid 600 MG Oral Capsule
    Other Intervention Name(s)
    Thioctic acid
    Intervention Description
    Universal antioxidant
    Primary Outcome Measure Information:
    Title
    The change in carotid artery intima-media thickness (CIMT)
    Description
    Measurement of carotid intima-media thickness (CIMT) which is mainly used to assess subclinical atherosclerosias and its assessment is based on ultrasound transducer
    Time Frame
    Baseline and 6 months
    Secondary Outcome Measure Information:
    Title
    The change in serum level of hs-CRP
    Description
    High sensitivity C- reactive protein (hs-CRP) which will be assessed by ELISA.
    Time Frame
    Baseline and 6 months
    Title
    The change in serum level (MDA)
    Description
    Malondialdehyde (MDA) which will be assessed by colorimetric method.
    Time Frame
    Baseline and 6 months
    Title
    The change in the serum level of VCAM-1
    Description
    Vascular cell adhesion molecule-1 (VCAM-1) a marker of endothelial dysfunction which will be assessed by ELISA.
    Time Frame
    Baseline and 6 months
    Title
    The change in the serum level of Apelin
    Description
    Serum Apelin a marker of atherosclerosis which will be assessed by ELISA
    Time Frame
    Baseline and 6 months
    Title
    Lipid profile measuremt
    Description
    Total cholesterol (TC), triglyceride (TG) and HDL-C will be assessed by enzymatic colorimetric method.
    Time Frame
    Baseline and 6 months
    Title
    Change in plasma level of (HbA1c %)
    Description
    Glycated hemoglobin (HbA1c %) will be measured by ion exchange micro-column chromatographic method.
    Time Frame
    Baseline and 3,6 months
    Title
    Fast blood glucose measuremt
    Description
    Fasting blood glucose will be determined by glucose oxidase method.
    Time Frame
    Baseline and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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…). Patients with liver disease. Patients with thyroid disease. Patients with seizures.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sara SA Harby, Master
    Phone
    01128743303
    Email
    saraharby171@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tarek TM Mostafa, Professor
    Phone
    01154594035
    Email
    tarek.mostafa@pharm.tanta.edu.eg

    12. IPD Sharing Statement

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    Role of Alpha-lipoic Acid in Diabetes Melitus Type 1

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