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临床试验/NCT02891668
NCT02891668已完成不适用

Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Changes in quality of life as measured with the ThyPro questionaire

研究概览

简要总结

This project has the following primary aims:

The main objective is to delineate the association between changes in Resting energy expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4 treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after 1 year of treatment.

Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes in cognitive function and changes in body composition before and after one year of treatment and furthermore changes in insulin resistance following changes in body composition and free fatty acids (FFA).

详细描述

Subjects and Methods:

74 newly diagnosed hypothyroid patients of both genders and age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy. Participants will get an appointment immediately after diagnosis to avoid unnecessary delay of treatment. Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.

  • Psychological test using:

  • ThyPRO a thyroid-specific quality of life questionnaire(18),

  • Cognitive function by CALCAP® Abbreviated Test Battery,

  • Perceived cognitive deficit questionnaire (Perceived Deficits Questionaire)

  • Major Depression Inventory (MDI) questionnaire

  • REE will be measured by a CCM-express calorimeter,

  • DEXA-scan

  • Blood samples will be taken and patients will be characterized through basic information.

  • Insulin resistance will be assess through an oral glucose tolerance test (OGTT) At end of the first experimental day patients will start L-T4 therapy following national guidelines, with regular control of thyroid hormones to ensure optimal treatment. When patients are euthyroid and TSH is below 4 * 10-3 International Units pr liter (mU/l) patients will have blood samples monitored every 3 months for the rest of the trial.

After 6 and 12 months of treatment patients will undergo a similar experimental day and return to their general practitioner or outpatient clinic.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • TSH > 10 mU/liter

排除标准

  • Serious competing illness
  • Pregnancy or planning to become pregnant
  • Thyroidectomized patients
  • Unable to speak and understand danish

研究组 & 干预措施

Hypothyroid

Levothyroxine treatment

干预措施: Levothyroxine treatment (Drug)

结局指标

主要结局

Changes in quality of life as measured with the ThyPro questionaire

时间窗: 1 year

Changes in resting energy expenditure in KCal/day

时间窗: 1 year

次要结局

  • Changes in Perceived Deficit Questionaire(1 year)
  • Changes in insulin resistance evaluated by MATSUDA index(1 year)
  • Changes in insulin resistance evaluated by HOMA index(1 year)
  • Changes in cognitive tests(1 year)
  • Changes in body composition asses through lean mass(1 year)
  • Changes in body composition asses through visceral adipose tissue(1 year)
  • Changes in body composition asses through fat mass(1 year)
  • Changes in free fatty acids(1 year)
  • Changes in cholesterol(1 year)
  • Changes in serum triglycerides(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bjarke Borregaard Medici

MD, PH.d. student

Herlev Hospital

研究点 (1)

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