CTIS2023-509217-37-00招募中1 期
Influence of various fast-acting mealtime insulin preparations in individuals with type 1 diabetes, with slow, moderate, and rapid gastric emptying, on postprandial blood glucose and the formation of reactive oxygen species - KKB_2023_FActIn-T1DM
Katholisches Klinikum Bochum gGmbH0 个研究点目标入组 20 人开始时间: 2024年1月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
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 65+（—）
- 性别
- All
入选标准
- •Diabetes mellitus type 1, HbA1c = 6.0% [42 mmol/l] and = 8.0% [64 mmol/l], Generally good overall health, Age = 18 and = 80 years, Body mass index (BMI) = 18.5 and = 35 kg/m²
排除标准
- •Other types of diabetes (e.g., type 2 diabetes) or unspecified diabetes mellitus, Blood donation within the past 12 weeks prior to the study, Pregnancy, Clinically relevant thyroid dysfunction (hypo- and hyperthyroidism) without stable treatment, Substance abuse (including alcohol consumption of more than 20g of alcohol or more than 10 cigarettes per day), Indications of a severe illness that could impact participation in the study or the results (e.g., epilepsy, cardiovascular disease, pulmonary disease, active cancer), Participation in other medical studies within the past three months, Inability to provide informed consent, Unwillingness to consume the test meal (e.g., refusal to eat chicken eggs), Conventional insulin therapy, Proliferative retinopathy, Inadequate metabolic control (HbA1c < 6.0% [42 mmol/l] or > 8.0% [64 mmol/l]), Allergies or intolerances that could hinder the study's execution, Recurrent or severe hypoglycemia within the past four weeks before study enrollment, indicating a need for therapy optimization, Positive medical history of gastrointestinal diseases, especially symptomatic upper or lower gastrointestinal tract disorders (e.g., Crohn's disease, ulcerative colitis, celiac disease, pancreatitis, gastric conditions like gastroparesis), History of gastrointestinal surgery (except uncomplicated cholecystectomy or appendectomy), Use of medication within 2 weeks before the study or ongoing use of medications that could affect gastrointestinal motility, body weight, or appetite, Chronic kidney insufficiency (eGFR < 30 ml/min according to CKD-EPI formula), Chronic liver disease (transaminases > 2 times the upper normal limit), Anemia (Hb < 11.5 mg/dl in women or < 13.5 mg/dl in men)
研究者
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