The Possible Effects of Roflumilast on Obesity Related Disorders
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in blood glucose
研究概览
简要总结
Evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism, insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prediabetic patients (fasting blood glucose between 100 mg/dl and 125 mg/dl or HbA1C within the range 5.7% and 6.4%).
- •Obese subjects (BMI ≥30 kg/m2 and <40 kg/m2).
排除标准
- •Patients with morbid obesity (BMI > 40 kg/m2).
- •Patients already on weight lowering agents or weight loss program.
- •History or current diagnosis of major depressive disorder or other psychiatric disorders that in the opinion of the investigator would make participation unsafe for the participant.
- •Moderate to severe liver disease (Child-Pugh B or C), renal disease, thyroid disease, cardiovascular disease, peripheral vascular disease or coagulopathy.
- •Women will be excluded from our study if they are pregnant, breastfeeding, currently on contraceptive pills or if they plan to become pregnant prior to the end of the study.
- •Patients on medications that can interfere with glucose or lipid metabolism (e.g. hypoglycemic agents, corticosteroids, anti-hyperlipidemics, non-selective β-blockers thiazides, etc.) and subjects with organic causes of obesity.
- •Diabetic patients and patients with any inflammatory disease.
- •Patients on cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin, etc.)
研究组 & 干预措施
Roflumilast arm
干预措施: Roflumilast (Drug)
Placebo arm
干预措施: placebo (Drug)
结局指标
主要结局
Change in blood glucose
时间窗: baseline and 3 months later
using glucose oxidase method for assessment of blood glucose and substracting pre-treatment from post-treatment values.
Change in patients body weight
时间窗: baseline and 3 months later
substracting pre-treatment from post-treatment values.
Change in plasma insulin level
时间窗: baseline and 3 months later
substracting pre-treatment from post-treatment values of plasma insulin.
Change in HOMA-IR index
时间窗: baseline and 3 months later
HOMA-IR will be calculated for all patients at baseline and 3 months later.
Change in blood lipid levels
时间窗: baseline and 3 months later
blood lipid levels will be measured at baseline and 3 months after treatment including total cholesterol, triglycerides, HDL-C and LDL-C.
次要结局
- Changes in malondialdehyde serum level (MDA)(baseline and 3 months later)
- Changes in TNF-alfa serum level(baseline and 3 months later)
研究者
Sara Mohammed Zayed
Pharm D
Tanta University