EUCTR2019-000676-42-FR进行中（未招募）1 期
Efficacy of metformin versus sitagliptin on benign thyroid nodules size in type 2 diabetes: a 2-years prospective multicentric study - METNODTHYR
niversity Center Hospital of Guadeloupe0 个研究点目标入组 90 人开始时间: 2020年1月14日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •- Patients with T2DM aged 18 to 65 years;
- •- Uncomplicated T2DM, evolving for less than 3 years;
- •- Patients with HbA1c levels between 7 and 8% (after the run-in period)
- •- Patients with at least one TN = 2 cm non-cystic, whose benignity will be confirmed by a fine-needle aspiration cytology performed twice regardless of ultrasound TIRADS score;
- •- Naive subjects of any treatment: never received an anti-diabetic treatment OR received an anti-diabetic treatment of less than 30 days since diagnosis OR did not receive an anti-diabetic treatment during the 30 days before screening;
- •- Patients with a creatinine clearance > 60 ml/min;
- •- Informed and written consent signed by the patient and the investigator;
- •- Affiliation to the national social health system or equivalent.
- •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 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Subjects without adequate or impaired decisional abilities for consent to research and placed under guardianship, curatorship or safeguard of justice
- •- Pregnant or breastfeeding woman
- •- Woman of childbearing potential without effective contraception (estroprogestative, presentative, intrauterine device)
- •- Suspect thyroid nodules in ultrasound (TIRADS 4 to 5) with confirmation after a fine-needle aspiration cytology;
- •- Thyroid function abnormalities or a history of thyroid disease;
- •- Thyroid nodules whose size or symptoms (compressive signs) require surgery
- •- Urinary iodures <100ug /L
- •- Thyroid autoimmunity: positive anti-peroxidase, thyroglobulin or anti-TSH receptors antibodies
- •- Levothyroxine treatment
- •- History of cervical radiotherapy or thyroid surgery
- •- Type 1 diabetes
- •- Insulin deficiency
- •- History of hypersensitivity to one of the active substances
- •- History of pancreatitis
- •- Obesity linked to endocrine disease
- •- Presence of severe complications of T2DM (ischemic heart disease, heart failure with reduced left ventricular ejection fraction, severe lower extremity arteritis, gangrene, retinopathy, end-stage renal failure, cerebrovascular accident)
- •- HbA1c levels > 8% after the run-in period
- •- Liver diseases (liver failure, cirrhosis, viral hepatitis B or C)
- •- Acute alcoholic intoxication, chronic alcoholism
- •- Psychiatric diseases (depression, schizophrenia)
- •- Neurological diseases (epilepsy, demyelinating diseases, etc.)
- •- Treatment influencing the morphology or thyroid function: corticosteroids, lithium etc. ...
- •- Acute conditions that may impair renal function such as: dehydration, severe infection…
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