NL-OMON53214招募中不适用
Investigating disturbances in glucose and glycogen dynamics in prediabetes - Glucose and glycogen dynamics in prediabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
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
- •General for all groups:
- •-Participants are able to provide signed and dated written informed consent
- •prior to any study specific procedures
- •- Participants should have suitable veins for cannulation or repeated
- •venipuncture
- •- Women are post-menopausal (defined as at least 1 year post cessation of
- •- Aged >= 45 and <= 75 years
- •- Body mass index (BMI) 27 - 38 kg/m2
- •- Stable dietary habits (no weight loss or gain >5kg in the past 3 months)
- •- Sedentary lifestyle (not more than 2 hours of sports per week)
- •Prediabetic groups specifically:
- •IFG: fasting blood glucose between 6.1 and 6.9 mmol/L and 2-h plasma glucose
- •after ingestion of 75g oral glucose load below 7.8 mmol/L
- •IGT: fasting blood glucose below 6.1 mmol/L and 2-h plasma glucose after
- •ingestion of 75g oral glucose load between 7.8 and 11.1 mmol/L
排除标准
- •General for all groups:
- •- Previous enrolment in a clinical study with an investigational product during
- •the last 3 months or as judged by the Investigator
- •- Previously diagnosed with type 2 diabetes
- •- Patients with congestive heart failure and/or severe renal (eGFR <50mL/min)
- •and or liver insufficiency or another condition that may interfere with
- •outcomes measured in this study.
- •- Any contra-indication MRI scanning
- •- Alcohol consumption of >2 servings per day for men and >1 servings per day
- •- Smoking in the past 6 months
- •- Medication use that may influence main outcome parameters, specifically the
- •following types of medication: Type 2 diabetes medication, corticosteroids,
- •thyroid medication.
- •- Participation in research or medical examination that included PET scanning
- •in the last 3 months
- •Healthy overweight specifically:
- •- Any of the criteria mentioned above to define prediabetes
- •Prediabetic groups who will undergo acipimox treatment:
- •- Hypersensitivity to acipimox or to any of the excipients in the tablet
- •- Peptic ulcer/dyspepsia
- •- Medication use that interfere with Acipimox (statins, fibrates).
- •A medical doctor will judge participation eligibility based on the medical
- •history questionnaire, medication use and fasting blood parameters. If the
- •medical doctor advises that a volunteer cannot participate, the volunteer will
- •be excluded from enrollment.
研究者
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