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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Sherif T Ahmed, teachig assistant
- Número de telefone: 01012661535
- E-mail: Sta11@fayoum.edu.eg
Estude backup de contato
- Nome: Huda M Rabie, professor
- Número de telefone: 01144073236
- E-mail: hoda.ahmed@pharm.bus.edu.eg
Locais de estudo
-
-
-
Al Fayyum, Egito
- Fayoum University
-
Contato:
- Sherif T Ahmed, teaching assistant
- Número de telefone: 01012661535
- E-mail: Sta11@fayoum.edu.eg
-
Contato:
- Sherif T Rabie, teaching assistant
- Número de telefone: 01144073236
- E-mail: hoda.ahmed@pharm.bus.edu.eg
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: 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 Placebo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in glycated hemoglobin (HbA1c)
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Doenças Metabólicas
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Resistência a insulina
- Hiperinsulinismo
- Doenças Nutricionais e Metabólicas
- Diabetes Mellitus, Tipo 2
- Síndrome metabólica
- Compostos de enxofre
- Produtos químicos orgânicos
- Ácidos graxos
- Lipídios
- Ácidos carboxílicos
- Enzimas e coenzimas
- Coenzimas
- Tiofenos
- Ácido Tióctico
Outros números de identificação do estudo
- R 916
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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