Aronia in the Type 2 Diabetes Treatment Regimen
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Blood glucose incremental area under the curve (iAUC)
研究概览
简要总结
In a triple-crossover study, the effect aronia consumption on type 2 diabetes will be examined. 48 type 2 diabetes patients need to complete the trial. Each patient will receive two daily doses of both fermented aronia, aronia, or placebo for eight weeks each. There will be 3 weeks wash-out periods between the intervention periods. Before and after the intervention periods, various measurements will be performed to assess the effects of aronia, fermented aronia, and placebo on type 2 diabetes.
详细描述
Hypothesis: Fermented aronia extract (FAE) improves glycaemia and lipidaemia in T2D more efficiently than both non-fermented aronia extract (NFAE) and placebo.
Research questions:
Does FAE/NFAE when administered to T2D subjects:
- Improve glucose responses to an oral glucose tolerance test and HbA1C?
- Improve fasting LDL-, HDL- and total cholesterol?
- Reduce insulin resistance and increase total antioxidative/anti-inflammatory capacity?
- Increase circulating GLP-1 and GIP levels with lower DPP4 activity?
- Alleviate hypertension and obesity?
Methods A total of 48 T2D patients is needed for the double blind, randomized triple cross-over trial. The patients will consume FAE, NFAE or placebo daily divided into two doses which is expected to provide a sufficient dose of bioactive phenolic compounds. The patients will be recruited through "forsoegsperson.dk", "sundhed.dk", and flyers placed at Aarhus university hospital (AUH). T2D patients with fasting blood glucose ≤ 12 mM and HbA1c > 6.1% and < 10%, without severe comorbidities, will be included. Before enrolment, the patients receive all necessary study information (written and oral) including potential adverse effects (e.g. aronia allergy), and they will have to provide their informed consent (visit 1). There will be an assessment of whether the patients fulfill the criteria as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes
- •≥30 ≤80 years of age
- •Fasting blood glucose ≤12 mmol/liter.
- •HbA1c > 6,1% og <10%(>43 og < 86 mmol/mol) if patients are in medical diabetes treatment
- •HbA1c > 6,5% og <10% (>48 og < 86 mmol/mol) if patients are not in medical diabetes treatment
排除标准
- •Changes in diabetes within the last 3 months.
- •Serious comorbidities, including cardiovascular-, neurological-, psychological- and/or renal diseases.
- •Pregnant or planned pregnancy.
结局指标
主要结局
Blood glucose incremental area under the curve (iAUC)
时间窗: Throughout the study (up to 1 year)
Measured during the OGTTs
Blood glucose total area under the curve (tAUC)
时间窗: Throughout the study (up to 1 year)
Measured during the OGTTs
次要结局
- HbA1c(Throughout the study (up to 1 year))
- Microbiomics(Throughout the study (up to 1 year))
- Insulin(Throughout the study (up to 1 year))
- Incretins(Throughout the study (up to 1 year))
- DPP4 activity(Throughout the study (up to 1 year))
- C-reactive protein(Throughout the study (up to 1 year))
- Adiponectin(Throughout the study (up to 1 year))
- Glucose(Throughout the study (up to 1 year))
- Fructosamin(Throughout the study (up to 1 year))
- Lipids(Throughout the study (up to 1 year))
- Glucagon(Throughout the study (up to 1 year))
- Inflammatory and oxidative markers(Throughout the study (up to 1 year))
- Advanced glycation end products(Throughout the study (up to 1 year))
- Metabolomics(Throughout the study (up to 1 year))