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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Sherif T Ahmed, teachig assistant
- Telefonnummer: 01012661535
- E-post: Sta11@fayoum.edu.eg
Studera Kontakt Backup
- Namn: Huda M Rabie, professor
- Telefonnummer: 01144073236
- E-post: hoda.ahmed@pharm.bus.edu.eg
Studieorter
-
-
-
Al Fayyum, Egypten
- Fayoum University
-
Kontakt:
- Sherif T Ahmed, teaching assistant
- Telefonnummer: 01012661535
- E-post: Sta11@fayoum.edu.eg
-
Kontakt:
- Sherif T Rabie, teaching assistant
- Telefonnummer: 01144073236
- E-post: hoda.ahmed@pharm.bus.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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. |
|
Placebo-jämförare: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in glycated hemoglobin (HbA1c)
Tidsram: 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
Tidsram: 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
Tidsram: Baseline to Week 12
|
Measured in mmHg. Change = Week 12 minus baseline. |
Baseline to Week 12
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sherif T Ahmed, teaching assistant, Fayoum University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Diabetes mellitus
- Insulinresistens
- Hyperinsulinism
- Närings- och metabola sjukdomar
- Diabetes mellitus, typ 2
- Metaboliskt syndrom
- Svavelföreningar
- Organiska kemikalier
- Fettsyror
- Lipider
- Karboxylsyror
- Enzymer och koenzymer
- Koenzymer
- Tiofener
- Tioctic syra
Andra studie-ID-nummer
- R 916
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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