Effectiveness of an intensive lifestyle intervention program in improving erectile dysfunction in patients with Type 2 diabetes in India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- 1. Evaluate the impact of the FFD protocol on improvement in Erectile dysfunction score from severe (5-7) to mild (17-21) in patients with T2D.
研究概览
简要总结
The proposed study is a pilot intervention with a single-arm pre-post design that aims to assess the prevalence of erectile dysfunction (ED) in patients with T2DM enrolled in a diabetes remission program and to determine the effect of the program in improving ED outcomes. Specific Objectives are: 1) To estimate the prevalence of ED among patients with T2D. 2) To assess the effect of the intervention program on improvement in ED in patients with T2D. 3) To explore the association between the ED in patients with diabetes and other health comorbidities as well as mental health. The intervention includes diet, exercise, medical management of diabetes. The duration of the intervention will be 6 months. Data will be collected at two-point times, at the baseline and end-line at the end of 6 months after the delivery of the intervention. Compliance data will be collected from patients based on their biochemical parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •30 to 60 years at the time of enrollment
- •Male participants with confirmed type 2 Diabetes; All patients on treatment with oral hypoglycemic agents and/or Insulin or any Ayurvedic anti-diabetic medications or HbA1c ≥ 48 mmol/mol (6.5%) with or without medication
- •Agree to examinations as per the study protocol, undergo the lifestyle intervention program & post-program evaluation
- •Participants who are well-oriented in time, and space & as a person
- •Provide written informed consent.
排除标准
- •Type 1 diabetes (due to autoimmune β-cell destruction) usually leads to absolute insulin deficiency, including latent autoimmune diabetes in adulthood.
- •Specific types of diabetes due to other causes, such as monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young), diseases of the exocrine pancreas (such as cystic fibrosis and pancreatitis), and drug- or chemical-induced diabetes (such as glucocorticoid use, HIV/AIDS treatment, or organ transplantation).
- •Patients who required hospitalization for any diabetes-related complications or for depression in the last 6 months or are on antipsychotic drugs.
- •Known cancer 5) Patients with conditions that could significantly affect penile erection that include spinal cord injuries and known or suspected chronic debilitating illnesses such as chronic heart failure, chronic renal failure, chronic liver, disease, chronic obstructive pulmonary diseases, tuberculosis, and malignancy, regardless of diabetes.
- •Patients on drug treatment of ED or drug-induced ED for example beta blockers, antihypertensive medication, antidepressants and other medicines for mental health conditions, antihistamine medicines, or parkinson disease medicines) 7) Patients with self reported genital anatomic deformities.
结局指标
主要结局
1. Evaluate the impact of the FFD protocol on improvement in Erectile dysfunction score from severe (5-7) to mild (17-21) in patients with T2D.
时间窗: Erectile dysfunction will be measure at baseline, 6 months and at 1 year
次要结局
- 1. Estimate the prevalence of ED among patients with T2D.(2. Explore the association between erectile dysfunction (ED) & health comorbidities, as well as mental health.)
研究者
Dr Pramod Tripathi
Freedom From Diabetes Research Foundation