NL-OMON53644招募中不适用
The effects of cold-induced shivering at different intensities on 24-hour blood glucose profiles in pre-diabetic individuals and patients with type 2 Diabetes Mellitus - Shivering and Glucose Dynamics (SHIVER)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
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
- •Inclusion criteria for all subjects:
- •1) Able to provide signed and dated written informed consent prior to any
- •study-specific procedures
- •2) Have suitable veins for cannulation or repeated venipunture
- •3) Be men or postmenopausal (at least 1 year post cessation of menses) females
- •4) Aged between 40 - 75 years at the start of the study
- •5) Have body mass index (BMI) >= 27 and <= 38 kg/m2
- •6) Have stable dietary habits (no weight loss or gain > 5 kg within the past 3
- •7) Have no signs of active cardiovascular disease or liver malfunction
- •Additional inclusion criteria for prediabetic subjects:
- •Pre-diabetes based on one or a combination of the following criteria:
- •- Impaired Glucose Tolerance (IGT): plasma glucose values >= 7.8 mmol/l and <=
- •11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening
- •- Impaired Fasting Glucose (IFG): Fasting plasma glucose >= 6.1 mmol/l and <= 6.9
- •- Insulin Resistance: glucose clearance rate <= 360 mL/kg/min, as determined
- •using OGIS120
- •- HbA1c of 5.7-6.4%
- •Additional inclusion criteria for Type 2 Diabetes Mellitus patients:
- •1) Diagnosed with T2DM at least 1.5 years before the start of the study
- •2) Have well-controlled diabetes at the time of screening, defined as HbA1c
- •levels < 8.5 %
- •3) Have no signs of active diabetes-related co-morbidities, including active
- •cardiovascular diseases, diabetic foot, polyneuropathy or retinopathy
- •4) Are on a diet treatment OR on an oral glucose lowering medication: metformin
- •only or in combination with sulfonylurea agents and/ or on stable dose of a
- •DPPIV inhibitor treatment for at least the last 3 months
排除标准
- •For all subjects:
- •1) Not meeting the respective inclusion criteria
- •2) Participation in a clinical study with an investigational product during the
- •last 3 months or as judged by the investigator
- •3) Having uncontrolled hypertension
- •4) Having Hb < 8 mmol/L (men) or Hb < 7 mmol/L (women)
- •5) Consuming alcohol > 2 servings per day (men) or > 1 serving per day (women)
- •6) Not wanting to be informed about unexpected medical findings during the
- •screening/ study
- •7) Being engaged in structured exercise > 2h per week
- •8) Smoking
- •9) Being cold-acclimated, e.g. having taken daily extended cold baths, working
- •in a refrigerated environment, or practicing regular cold-water swimming/
- •showering within 1 month of starting the study
- •For pre-diabetic participants:
- •1) Being previously diagnosed with Type 2 Diabetes Mellitus
- •For Type 2 Diabetes Mellitus patients:
- •1) Being insulin-dependent
研究者
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