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临床试验/NCT04148183
NCT04148183已完成2 期

Randomized Clinical Trial, Effect of Metformin and Rosiglitazone Over Glucose Homeoastasis in no Diabetic With Metabolic Syndrome Patients.

J JESUS VENEGAS, MD0 个研究点目标入组 30 人开始时间: 2004年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
主要终点
INSULIN RESISTANCE

研究概览

简要总结

To compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (GH) in no diabetic metabolic syndrome individuals. A randomized blinded clinical trial did in patients with metabolic syndrome (n=30), without diabetes. Prior to detailed information and signature of informed consent by patients were done three treatment groups by randomized technique; a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks. GH was measured before and after treatment using oral glucose tolerance test (OGTT), and IR-index (Homeostatic Model). Determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, HDL-cholesterol and insulin.

详细描述

Metabolic syndrome is a risk factor for diabetes mellitus characterized by insulin resistance, hypertension, triglyceride elevation, low levels of high-density lipoproteins, and obesity. Metformin and rosiglitazone are two insulinosensensitizers used in the treatment of diabetes. Now there is controversy over the use of insulinossensitizers in non-diabetic patients with metabolic syndrome. To compare the effect of insulin sensitizing drugs (metformin and rosiglitazone) over glucose homeostasis (GH) in no diabetic metabolic syndrome individuals. Randomized blinded clinical trial in patients with metabolic syndrome without diabetes was done, sample size (n=30). Prior to detailed information and signature of informed consent by patients was randomized forming three treatment groups, a) Placebo, b) Metformin (850 mg/day), c) Rosiglitazone (4 mg/day), treatment was administered for 8 weeks. GH was measured before and after treatment using oral glucose tolerance test (OGTT), and IR-index (Homeostatic Model). Determination was performed on weight, size, body mass index, plicometry, blood pressure, fasting glucose levels, triglycerides, HDL-cholesterol and insulin. Statistic no parametric (Kruskal Wallis, Wilcoxon, U Mann Whitney) to compare characteristics inter o intra groups was done. Exact Fisher test was used for qualitative variable, and consider significance with p<0.05.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 18 years old.
  • Metabolic Syndrome criteria of World Health Organization .

排除标准

  • Diabetes Mellitus
  • Allergic to Metformin,
  • Allergic to rosiglitazone.
  • Hepatic disease.
  • Hearth disease.

研究组 & 干预措施

Metformin Group

Experimental

Metformin (850 mg/day) treatment was administered for 8 weeks

干预措施: Metformin group (Drug)

Rosiglitazone Group

Experimental

Rosiglitazone (4 mg/day), treatment was administered for 8 weeks

干预措施: Rosiglitazone group (Drug)

Placebo Group

Placebo Comparator

Placebo treatment was administered for 8 weeks

干预措施: Placebo oral tablet (Drug)

结局指标

主要结局

INSULIN RESISTANCE

时间窗: 8 weeks

INSULIN RESISTANCE index (Homeostatic Model) is method that need insulin concentration and glucose in blood to calculate index.

次要结局

  • oral glucose tolerance test (OGTT),(8 weeks)

研究者

发起方
J JESUS VENEGAS, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

J JESUS VENEGAS, MD

Master Degree, Nephrologist

Universidad de Colima

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