Efficacy and Safety of Colchicine compared to Placebo in Metabolic Syndrome Patients on Background Standard treatment. A Randomized, Double-Blind, Placebo- Controlled Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Percentage change in mean hsCRP levels, waist circumference, TGA, HDL, weight, BP HOMA -IR
研究概览
简要总结
The trial is conducted by the department of pharmacology with endocrinology for the duration of 18 months. Participants will be explained about the procedures, treatment and side effect of interventional drug, in detail in the language best understood by them. After taking the informed consent,metabolic syndrome patients who meet inclusion criteria and willing to participate in study will be recruited. Subjects will be randomized into intervention and control groups based on computer generated randomization list. The control group will be given identical placebo and standard of care [stable oral dose of antihypertensives, anti-diabetics, statins and lifestyle modifications].
Intervention group will receive oral colchicine 0.5 mg once daily along with standard of care. Screening of participants for base line parameters [fasting insulin, lipid profile, fasting blood sugar, hsCRP, HbA1c, are done at -1 week [visit-1]. Participants are randomized to receive study medications at week 0 [visit -2]. hsCRP, abdominal circumference, weight, blood pressure recording and BMI will be done at week 4. All the base line parameters will be repeated at week 12. LFT and RFT will be done on week -1 and repeated on week 16. At week -1, 4, 12 and 16, about 10 ml of blood will be collected for study parameters. Participants will be given a diary to record any untoward event or any adverse drug reaction. Medication compliance will be checked by Pill count method. The effect of colchicine on inflammation markers, weight, abdominal circumference and BP will be recorded and HOMA-IR will be calculated. Participant complaints and clinical status will be assessed during each visit. If any side effects are reported, they will be advised to come to the study site for the management. The adverse effects will be reported to PVPI of india
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1]BMI greater than or equal to 30mg/dl.
- •2]Impaired glucose tolerance less than 200mg/dl and greater than 140 mg/dl at 2hrs of OGTT and FBS is greater than 100 and less than 126 mg/dl.
- •3]All patients having fasting blood sugars greater than or equal to 126mg/dl and post prandial greater than 140 mg/dl after 120 minutes and HbA1c greater than or equal to 5.7% and less than or equal to 10% 4]HTN greater than or equal to 130 mm of Hg systolic pressure and greater than equal to 85mm of Hg diastolic pressure 5]Waist circumference greater than 102cm in Men and 88 cm in women 5]triglycerides greater than or equal to 150 to 250 mg/dl and HDL less than 40 mg/dl.
排除标准
- •Exclusion Criteria: a.
- •History of hypersensitivity to colchicine b.
- •Participants on myoinositol in metabolic syndrome, aspirin, NSAIDS, corticosteroids c.
- •liver function tests Parameter Normal Range (Male) Normal Range (Female) Alanine aminotransferase 10–55 U/L 7–30 U/L Aspartate aminotransferase 10–40 U/L 9–25 U/L Alkaline Phosphatase 45–115 U/L 30–100 U/L Total Bilirubin 0–1.0 mg/dL 0–1.0 mg/dL 0–0.4 mg/dL Direct Bilirubin 0–0.4 mg/dL Prothrombin Time 11.2–13.2 seconds 11.2–13.2 seconds greater than 3 times of Upper limit value (8)
- •Renal function tests Parameter Normal Range Serum Creatinine 0.6–1.2 mg/dL Blood Urea Nitrogen (BUN) 7–20 mg/dL (8) greater than 3 times of Upper limit value
- •Pregnancy and Lactating mothers
- •On weight loss program.
结局指标
主要结局
Percentage change in mean hsCRP levels, waist circumference, TGA, HDL, weight, BP HOMA -IR
时间窗: from baseline to end of 12 weeks.
次要结局
- 1. Incidence of adverse 1.drug reactions as proportions(2. Measurement of tolerability)
研究者
DR Poshala Srivarshini
ESIC MEDICAL COLLEGE AND HOSPITAL