Prospective Study for Evaluation of the Insulin Resistance, Lipid Metabolism and Sub Clinical Cardiovascular Disease in Women Who Initiate the Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method With in Follow-up for Two Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- insulin resistance
研究概览
简要总结
Objective:
The purpose of this study is to determine the etiology of the weight increase in Depot-medroxyprogesterone Acetate (DMPA) users.
Method:
Prospective study with 100 women, aged 18-40 years old and BMI < 30kg/m², paired with users of a non hormonal method follow for two years. Will be included only women who never used DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic alterations should elucidate the etiology, and the beginning of the sub clinical cardiovascular disease should be shown/discarded with the arterial evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-40 years
- •new users of DMPA
- •BMI<30kg/m²
排除标准
- •diabetes mellitus and 2 present or fasting glucose> 100mg/dl and / or blood glucose> 140mg/dl after ingestion of 75mg of oral glucose
- •first-degree relatives with diabetes mellitus
- •period of lactation
- •hypertension, with or without treatment
- •hyper and hypothyroidism
- •chronic renal failure
- •transplant of any organ
- •women using drugs that may be related to weight gain and / or development of insulin resistance and chronic use of corticosteroids, antipsychotics, statins, and thiazide,
- •hirsutism and/or hyperandrogenism
- •polycystic Ovary Syndrome (PCOS)
- •women with acanthosis nigricans
- •women who have used depoprovera at some point in their reproductive lives,
- •women who have performed bariatric surgery
结局指标
主要结局
insulin resistance
时间窗: 12 months
insulin resistance diagnosed by hyperinsulinemic-euglycemic clamp at 0 and 12 months
次要结局
- loss of bone mass(12 months)
- changes in clotting factors(12 months)
- eating disorder(12 months)
- weight gain(12 months)
研究者
Luis Bahamondes
MD Medical Doctor
University of Campinas, Brazil