EUCTR2011-000942-39-NL进行中（未招募）不适用
Effects of thyroid hormone treatment on mitochondrial function, ectopic fat accumulation, insulin sensitivity and brown adipose tissue in type 2 diabetes mellitus. - Thyroid and type 2 diabetes
CTMM, the Center for Translational Molecular Medicine0 个研究点目标入组 17 人开始时间: 2011年4月4日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 17
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Male or postmenopausal females
- •-Age 40-65 years
- •-Body mass index (BMI) < 40 and > 27 kg/m2
- •-Stable dietary habits (no weight loss/gain >3 kg in the last 6 months)
- •-Stable physical activity levels for at least six months
- •-Newly diagnosed hypothyroid, non-insulin dependent type 2 diabetic patients having TSH values higher then > 4.0 mU/l and lowered concentrations of free T4 < 8.0 pmol/l.
- •-Type 2 diabetic patients using sulphonylurea and or metformin therapy for at least six months with a constant dose for at least two months.
- •-Hypothyroid diabetic patients due to Hashimoto disease (TPO > 100 IE/ml; Tg > 344 IE/ml), should have no auto-antibodies against glutamic acid decarboxylase (GAD), IA-2 and insulin to exclude type 2 polyglandular autoimmune syndrome (PGAII) (to exclude type 1 diabetes).
- •-Type 2 diabetic patients should have a HbA1c level < 8.0%
- •-Type 2 diabetic patients will be included when having no diabetes-related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 17
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Unstable body weight
- •-Participation in an intensive weight-loss program or vigorous exercise program during the last year before the start of the study
- •-Medical history including active cardiovascular disease, i.e. history of coronary artery disease (i.e. history of angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting) or cardiac arrhythmias.
- •-Liver disease or liver dysfunction (ALT>2.5 x increased)
- •-Impaired renal function (kreatinine> 120 umol/L)
- •-Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
- •-Hb <7.4 mmol/l (12 g/dl) in women, and <8.1 mmol/l (13 g/dl) in men
- •-Abuse of drugs and/or alcohol
- •-Contraindications for MRI scanning (please see appendix III: MRI contraindication questionnaire)
- •-Patients with history of thyroid cancer
- •-Patients using a and/or ß blockers
- •-Severe diabetes which requires application of insulin or patients with diabetes-related complications
- •-History of psychiatric disease
- •-Diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy.
- •-Use of medications known to interfere with glucose homeostasis (i.e. corticosteroids, thiazolidendiones)
- •-Hypothyroid diabetic patients due to Hashimoto disease with positive test values for auto-antibodies against GAD, IA-2 and insulin to exclude type 1 diabetes.
- •-Use of anticoagulantia, other than platelet aggregation inhibitors.
- •-Patients that have donated blood in the past 6 months
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