A STUDY TO EVALUATE THE COGNITIVE DECLINE IN TYPE 2 DIABETES AND YOGA INTERVENTION
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- To assess the cognitive status in patients with type 2 diabetes
研究概览
简要总结
This study aims to assess the prevalence of cognitive dysfunction in patients with type 2 diabetes. This research will evaluate the effectiveness of a yoga intervention for those diagnosed with cognitive impairment.
This study also assesses the impact of this yoga program on various health metrics, including quality of life (QOL), glycemic control (measured by HbA1c, fasting and postprandial blood sugars), physical health markers (BMI and blood pressure), and other key biochemical parameters like the lipid profile. Ultimately, the research aims to provide a comprehensive understanding of the potential benefits of yoga as an integrative therapy for managing the multifaceted health challenges faced by people with type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •HbA1c greater than or equal to 7.0 to lesser than 10.5 All patients must give written informed consent.
排除标准
- •Type 1 Diabetes mellitus Patients with a serum creatinine concentration greater than 132.6 mmol/L (1.5 mg/dL) or liver function impairment (AST and ALT 2.5 times upper limit of normal range) Patients have laboratory test abnormality (biochemistry, haematology, or urinalysis) Patients with significant alcohol, drug or medication abuse Currently under a psychiatrist’s care or using antipsychotic or mood stabilizer medication or have diagnosed dementia or bipolar disorder or schizophrenia.
- •Pregnant or lactating Had a documented CVD event (MI, stroke) in past 12 months Participation is purely voluntary and there will be no coercion by the consenter.
- •Participants will not receive material compensation to join the study.
- •All participants will be assured that they have the right to voluntarily withdraw from the study at any time and that withdrawal will not affect their future medical care.
- •Participants will also be told that their diabetes care provider will be notified of their stress and depressive symptoms.
结局指标
主要结局
To assess the cognitive status in patients with type 2 diabetes
时间窗: 24 weeks
Improvement in cognitive function from baseline to 24 weeks
时间窗: 24 weeks
次要结局
- Improvement in Quality of life from baseline to 12 weeks(Change in HbA1c from baseline to 24 weeks)
研究者
Dr S Poongothai
Madras Diabetes Research Foundation