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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Sherif T Ahmed, teachig assistant
- Telefonnummer: 01012661535
- E-post: Sta11@fayoum.edu.eg
Studer Kontakt Backup
- Navn: Huda M Rabie, professor
- Telefonnummer: 01144073236
- E-post: hoda.ahmed@pharm.bus.edu.eg
Studiesteder
-
-
-
Al Fayyum, Egypt
- Fayoum University
-
Ta kontakt med:
- Sherif T Ahmed, teaching assistant
- Telefonnummer: 01012661535
- E-post: Sta11@fayoum.edu.eg
-
Ta kontakt med:
- Sherif T Rabie, teaching assistant
- Telefonnummer: 01144073236
- E-post: hoda.ahmed@pharm.bus.edu.eg
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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 komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in glycated hemoglobin (HbA1c)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline to Week 12
|
Measured in mmHg. Change = Week 12 minus baseline. |
Baseline to Week 12
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Sherif T Ahmed, teaching assistant, Fayoum University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Metabolske sykdommer
- Glukosemetabolismeforstyrrelser
- Sukkersyke
- Insulinresistens
- Hyperinsulinisme
- Ernæringsmessige og metabolske sykdommer
- Diabetes mellitus, type 2
- Metabolsk syndrom
- Svovelforbindelser
- Organiske kjemikalier
- Fettsyrer
- Lipider
- Karboksylsyrer
- Enzymer og koenzymer
- Koenzymer
- Tiophener
- Tioctic syre
Andre studie-ID-numre
- R 916
Plan for individuelle deltakerdata (IPD)
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