Assessment of the Improvement of the Cardiovascular Risk Profile in Obese Women After Correction of Iodine Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- change in fasting insulin
研究概览
简要总结
The study hypothesis is that iodine supplementation will lower serum TSH and leptin concentrations and thereby improve the lipid and glucose profile.
详细描述
The study will be a double blind, placebo controlled intervention study in obese women living in the Atlas foot mountains in Morocco, an iodine deficient area. Eligible subjects will be randomized into intervention and control group and will receive the respective supplement for 6 months. At baseline, midpoint and endpoint anthropometric as well as metabolic profile will be assessed. A health questionnaire will further be administered monthly when the tablets for the following month are distributed. Urine samples to determine iodine status will also be collected monthly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women of reproductive age (20 to 50 years)
- •Body mass index 27 to 40 kg/m2
- •Having received oral and written information about the aims and procedures of the study
- •Willing to comply with the study procedure
- •Having provided oral and written informed consent
排除标准
- •Chronic disease or gastrointestinal disorders
- •Nodular goiter
- •Regular use of medication (except oral contraceptives)
- •Pregnancy or lactation
- •Subject who cannot be expected to comply with study protocol
结局指标
主要结局
change in fasting insulin
时间窗: change from baseline to 6 months
change in the LDL cholesterol/ HDL cholesterol ratio
时间窗: change from baseline to 6 months
Change in TSH (thyroid-stimulating hormone)
时间窗: change from baseline to 6 months
次要结局
- fasting glucose(baseline, 3 months and 6 months)
- LDL cholesterol(baseline, 3 months and 6 months)
- HDL cholesterol(baseline, 3 months and 6 months)
- Urinary iodine(change from baseline to 6 months)
- plasma leptin(baseline, 3 months and 6 months)
研究者
Isabelle Aeberli
PhD
Swiss Federal Institute of Technology