ISRCTN27707180已完成不适用
Standardised dietary challenges in healthy and diabetic subjects
TNO0 个研究点目标入组 40 人开始时间: 2017年4月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28861127
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •All participants:
- •1. Men, aged 30 to 70 years, inclusive, on study day 1
- •2. Regular Dutch eating habits (3 main meals including bread) as assessed by the health and lifestyle questionnaire
- •3. Subject needs to be in a healthy condition or diagnosed as T2DM as assessed by
- •3.1. Medical history evaluation
- •3.2. Physical examination
- •3.3. Results of the pre-study blood test of biochemistry and HbA1c
- •4. Able to participate in the study, willing to give written informed consent and to comply with the study procedures and restrictions including no use of food supplements
- •5. Appropriate veins for cannula insertion
- •Healthy volunteers:
- •Body mass index (BMI): 20.0-25.0 kg/m2
- •1. Diagnosed as T2DM evidenced by a documented history and use of prescription oral glucose-lowering drug(s)
- •2. Body mass index (BMI): 25.1-34.9 kg/m2
排除标准
- •All participants:
- •1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 1 of this study
- •2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- •3. Uncontrolled hypertension: systolic blood pressure = 150 mmHg; diastolic blood pressure = 95 mmHg.
- •4. Having a history of medical or surgical events other than T2DM that may significantly affect the study outcome, including any inflammatory diseases (e.g. arthritis), psychiatric history, or any gastro-intestinal disorder.
- •5. Use of medication that might interfere with parameters to be measured or with one of the challenge tests
- •6. For diabetic subjects, fasting glucose < 7mmol/L after stopping oral antidiabetic treatment for 3 weeks
- •7. For diabetic subjects: use of insulin
- •8. Smokers
- •9. Active in competitive sports, active in recreational sports for more than 6 hours/week, physical activity considered by the screening physician to be too intense because it may jeopardize the study objectives (this includes but is not limited to unusual exercise, intermittent training programs, unusual manual labor, etc)
- •10. Reported unexplained weight loss or gain of > 4 kg in the month prior to the pre-study screening
- •11. Reported slimming or medically prescribed diet
- •12. A reported food allergy or sensitivity
- •13. Not having a general practitioner
- •14. Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
- •15. Not willing to give permission to have the general practitioner to be notified upon participation in this study.
研究者
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