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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sherif T Ahmed, teachig assistant
- Número de teléfono: 01012661535
- Correo electrónico: Sta11@fayoum.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: Huda M Rabie, professor
- Número de teléfono: 01144073236
- Correo electrónico: hoda.ahmed@pharm.bus.edu.eg
Ubicaciones de estudio
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-
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Al Fayyum, Egipto
- Fayoum University
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Contacto:
- Sherif T Ahmed, teaching assistant
- Número de teléfono: 01012661535
- Correo electrónico: Sta11@fayoum.edu.eg
-
Contacto:
- Sherif T Rabie, teaching assistant
- Número de teléfono: 01144073236
- Correo electrónico: hoda.ahmed@pharm.bus.edu.eg
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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. |
|
Comparador de placebos: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in glycated hemoglobin (HbA1c)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline to Week 12
|
Measured in mmHg. Change = Week 12 minus baseline. |
Baseline to Week 12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sherif T Ahmed, teaching assistant, Fayoum University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Resistencia a la insulina
- Hiperinsulinismo
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 2
- Síndrome metabólico
- Compuestos de azufre
- Químicos orgánicos
- Ácidos grasos
- Lípidos
- Ácidos carboxílicos
- Enzimas y coenzimas
- Coenzimas
- Tiofenos
- Ácido tióctico
Otros números de identificación del estudio
- R 916
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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