NL-OMON39459招募中4 期
Effects of thyroid hormone treatment on mitochondrial function, ectopic fat accumulation, insulin sensitivity and brown adipose tissue in type 2 diabetes mellitus - Thyroid function and insulin sensitivity
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •- Inclusion of patients who developed overt hypothyroidism due to subtotal thyroidectomy (strumectomy), except for those who underwent thyroidectomy because of thyroid carcinoma,
- •- 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. ;Inclusion criteria for non-diabetic de novo hypothyroid patientsMale or postmenopausal females
- •- Age 18-65 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, patients having TSH values higher then > 4.0 mU/l (and lowered concentrations of free T4 < 8.0 pmol/l)
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 of liver dysfunction (ALT>2.5 x increased)
- •- Impaired renalfunction (Kreat >100 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 β 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
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