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临床试验/NCT02993562
NCT02993562已完成不适用

Levothyroxine Substitution Therapy in Hypothyroid Patients - Impact on Appetite and Food Intake

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2015年8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
18
试验地点
1
主要终点
Changes in food intake at ad libitum meal

研究概览

简要总结

This project has the following primary aims:

To measure changes in appetite and food intake in newly diagnosed hypothyroid patients during the first six months after starting levothyroxine (L-T4) substitution therapy

Secondary aims are:

To delineate the effect of L-T4 substitution therapy on thyroid status, body weight, body mass index (BMI), body composition, physical activity, glycaemic control, postprandial gut and pancreatic hormone responses, gastric and gall bladder emptying, resting energy expenditure (REE), quality of life (QOL) and cognitive function

详细描述

18 newly diagnosed hypothyroid female patients and 18 healthy controls 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.

The study is devided in to three identical experimental days of approx. 6 hours. First experimental day placed before T4 treatment is initiated. Second day as soon as Thyroid Stimulating Hormone (TSH) is below 4 milli unit pr liter (mU/l). The Third experimental day after 6 months of T4 therapy.

For 5-7 days before each experimental day, the participants' physical activity energy expenditure (PAEE) will be monitored by an Actiheart® pedometer attached to the skin of the chest.

The last two days before each experimental day, the participants will follow a standardised diet following World Health Organization guidelines on energy requirements and nutrient composition according to gender, age and body weight Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.

Visual analog score on satiety and thirst will be filled out continuously. REE will be measured by a CCM-express calorimeter,

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
Female
接受健康志愿者

入选标准

  • TSH > 10

排除标准

  • Competing serious disease
  • Not able to understand written and spoken danish
  • Pregnancy
  • Thyroidectomized patients
  • Amiodarone treatment.

研究组 & 干预措施

Hypothyroid patients

Hypothyroid patients treated with Levothyroxine as part of normal treatment.

干预措施: Levothyroxine (Drug)

结局指标

主要结局

Changes in food intake at ad libitum meal

时间窗: 6 months

Changes in food intake at ad libitum meal measured at each experimental day

Satiety

时间窗: 6 months

Satiety measured on a visual analog score 13 times during each experimental day.

次要结局

  • Changes in gall bladder emptying(6 months)
  • Changes in GLP-1 hormones(6 months)
  • Changes in CCK hormones(6 Months)
  • Changes in Free-Fatty acids(6 Months)
  • Changes in lean mass assessed through lean mass(6 months)
  • Changes in blood sugar response to standardized meal.(6 Months)
  • Changes in Insulin hormones(6 Months)
  • Changes in fat mass assessed through lean mass with DEXA-scan(6 months)
  • Changes in stomach emptying(6 months)
  • Changes in GIP hormones(6 months)
  • Changes in GLP-2 hormones(6 Months)
  • Changes in PYY hormones(6 Months)
  • Changes in Glucagon(6 Months)
  • Changes in resting energy expenditure(6 months)
  • Changes in Gastrin hormones(6 Months)
  • Changes in C-peptide(6 Months)

研究者

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

Bjarke Borregaard Medici

Principial Investigator

Herlev Hospital

研究点 (1)

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