Alpha-Lipoic Acid Added to Dapagliflozin and Insulin Resistance in Type 2 Diabetes (ALA/DAPA)
Effect of Alpha-Lipoic Acid as Add-on Therapy to Dapagliflozin on Insulin Resistance and Glycemic Control in Patients With Type 2 Diabetes Mellitus: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
The goal of this clinical trial is to test whether adding alpha-lipoic acid (ALA) to usual treatment with metformin and dapagliflozin improves insulin resistance in adults with type 2 diabetes mellitus. The main questions it aims to answer are:
- Does ALA 600 mg once daily for 12 weeks lower insulin resistance, measured by the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), more than a placebo?
- Does ALA also improve blood sugar control, body weight and waist size, blood pressure, and blood fats, and is it safe and well tolerated?
Participants will:
- Keep taking their usual metformin and dapagliflozin 10 mg daily without any change.
- Take one capsule every day for 12 weeks, either ALA 600 mg or a matching placebo (a capsule with no active ingredient), assigned by chance.
- Visit the clinic at the start, at week 6, and at week 12 for blood tests, body measurements, and safety checks.
Researchers will compare the ALA group with the placebo group to see if ALA lowers HOMA-IR more than placebo.
調査の概要
詳細な説明
Type 2 diabetes mellitus is characterized by insulin resistance. No randomized trial has yet evaluated ALA added to dapagliflozin with HOMA-IR as the primary endpoint, which is the gap this study addresses.
The study is a single-center, parallel-group trial conducted at the Diabetes and Endocrinology Outpatient Clinic of Fayoum University Hospital, Egypt.
Randomization is 1:1 using a computer-generated. Allocation is concealed with sequentially numbered, opaque, sealed envelopes. Capsules are identical in appearance, so participants, treating clinicians, outcome assessors, and the statistician remain blinded until database lock.
Visits take place at baseline, Week 6, and Week 12. Fasting blood samples (glucose, insulin, HbA1c, lipid profile), weight, height, waist circumference, and blood pressure are collected at baseline and Week 12. Week 6 includes anthropometrics, blood pressure, adherence by pill count, and adverse event review. HOMA-IR is calculated as fasting insulin (microunits/mL) multiplied by fasting glucose (mg/dL), divided by 405.
Analysis follows the intention-to-treat principle. Between-group differences are tested with analysis of covariance (ANCOVA) using the baseline value as covariate, with a two-sided significance level of 0.05. The sample size was calculated for a standardized effect size of 0.75 (80% power, alpha 0.05), giving 28 participants per group, increased to allow for 15% dropout and an additional safety margin.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Sherif T Ahmed, teachig assistant
- 電話番号：01012661535
- メール：Sta11@fayoum.edu.eg
研究連絡先のバックアップ
- 名前：Huda M Rabie, professor
- 電話番号：01144073236
- メール：hoda.ahmed@pharm.bus.edu.eg
研究場所
-
-
-
Al Fayyum、エジプト
- Fayoum University
-
コンタクト：
- Sherif T Ahmed, teaching assistant
- 電話番号：01012661535
- メール：Sta11@fayoum.edu.eg
-
コンタクト：
- Sherif T Rabie, teaching assistant
- 電話番号：01144073236
- メール：hoda.ahmed@pharm.bus.edu.eg
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Adults aged 30 to 70 years, either sex
- Established diagnosis of type 2 diabetes mellitus
- HbA1c between 7.0% and 10.0% at screening
- On stable metformin plus dapagliflozin 10 mg daily for at least 3 months
- Able and willing to give written informed consent
Exclusion Criteria:
- Type 1 diabetes or secondary forms of diabetes
- Pregnancy, lactation, or planned pregnancy
- eGFR below 45 mL/min/1.73 m2
- Severe liver disease (Child-Pugh B or C)
- Acute coronary syndrome, stroke, or hospitalization for decompensated heart failure within the past 3 months
- Current or recent (within 4 weeks) use of alpha-lipoic acid, other high-dose antioxidant supplements, or insulin
- Known hypersensitivity to alpha-lipoic acid or placebo excipients
- Active malignancy or any condition that would prevent completing 12 weeks of follow-up
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：ALA + Metformin/Dapagliflozin
Alpha-lipoic acid 600 mg capsule taken orally once daily for 12 weeks, in addition to the participant's usual metformin and dapagliflozin 10 mg daily, which continue unchanged. |
Oral capsules dispensed at study visits. Unused capsules are returned and counted at Week 6 and Week 12 to measure adherence. |
|
プラセボコンパレーター：Placebo + Metformin/Dapagliflozin
Matching placebo capsule taken orally once daily for 12 weeks, in addition to the participant's usual metformin and dapagliflozin 10 mg daily, which continue unchanged. |
Capsule with no active ingredient, dispensed and counted on the same schedule as the ALA capsule. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
時間枠：Baseline to Week 12
|
HOMA-IR = fasting insulin (microunits/mL) x fasting glucose (mg/dL) / 405, calculated from fasting blood samples. Change = Week 12 value minus baseline value. |
Baseline to Week 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in glycated hemoglobin (HbA1c)
時間枠：Baseline to Week 12
|
Percentage points, measured by high-performance liquid chromatography. Change = Week 12 minus baseline. |
Baseline to Week 12
|
|
Change in fasting plasma glucose
時間枠：Baseline to Week 12
|
Measured in mg/dL after 10 to 12 hours of fasting. Change = Week 12 minus baseline. |
Baseline to Week 12
|
|
Change in systolic and diastolic blood pressure
時間枠：Baseline to Week 12
|
Measured in mmHg. Change = Week 12 minus baseline. |
Baseline to Week 12
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Sherif T Ahmed, teaching assistant、Fayoum University
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- R 916
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。