NL-OMON38384招募中不适用
Metabolic Characterization of Type 2 Diabetic, Obese, Lean Sedentary and Endurance Trained Individuals in vivo, ex vivo and in vitro - Metabolic Phenotyping
Human Biology0 个研究点目标入组 132 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •General inclusion criteria:
- •- Male sex
- •- Generally healthy with specifically no known cardiovascular disease or gastric ulcers, which can affect the study parameters
- •- Stable dietary habits (no weight loss/gain > 3 kg in the last 6 months);Group 1, type 2 diabetes participants:
- •- Ages 40-70 years
- •- BMI > 30 kg/m2
- •- Non-insulin dependent type 2 diabetes
- •- Must be on sulphonylurea(SU)- derivate or metformin therapy for at least six months with a constant dose for at least two months, or on dietary treatment for at least six months
- •- Well-controlled diabetes: HbA1c < 8%
- •- No diabetes related co-morbidities like cardiovascular diseases, diabetic foot, polyneuropathy, retinopathy
- •- No other (genetic) diseases that are associated with altered lipid profiles (including familial hypercholesterolemia and familiar combined hyperlipemia);Group 2, obese healthy control participants:
- •- Ages 40-70 years
- •- BMI > 30 kg/m2
- •- A plasma glucose level lower than 6.1 mmol/L
- •- No family history of diabetes
- •- No medication use
- •- Sedentary lifestyle; No participation in any physical activity for at least 2 years
- •- No other (genetic) diseases that are associated with altered lipid profiles (including familial hypercholesterolemia and familiar combined hyperlipemia);Group 3, endurance trained athletes:
- •- Ages 18-35 years
- •- BMI < 25 kg/m2
- •- No family history of diabetes
- •- No medication use
- •- VO2max > 55ml/kg/min
- •- Active in competitive endurance-exercise activities, 3 times a week for at least 2 years
- •- Stable level of training for at least 6 months
- •- No dyslipidemia (including familial hypercholesterolemia and familiar combined hyperlipemia);Group 4, lean healthy sedentary control participants:
- •- Ages 18-35 years
- •- BMI < 25 kg/m2
- •- No family history of diabetes
- •- No medication use
- •- VO2max < 55ml/kg/min
- •- Plasma glucose < 6.1 mmol/L
- •- Sedentary lifestyle; No participation in physical activity for more than 1 hour per week for at least 2 years
- •- No dyslipidemia (including familial hypercholesterolemia and familiar combined hyperlipemia)
排除标准
- •General exclusion criteria:
- •- Regular smokers
- •- Participation in other studies
- •- Female sex
- •- Insulin dependent diabetic individuals
- •- Participants with diabetes related diseases (diabetic foot, diabetic polyneuropathy, diabetic retinopathy etc.)
- •- Use of Thiazolidines (glitazone/rosiglitazone/pioglitazone/troglitazone)
- •- Use of anti-coagulants (not trombocyte-aggregation inhibitors)
- •- Aberrant ECG (with signs of ischemia or cardiac failure or arrythmias)
- •- Weight gain/loss > 3 kg in the last 6 months
- •- HbA1c < 7.8 in type 2 diabetic individuals
- •- Contraindications for MRS scans:
- •Electronic implants such as pacemakers or neurostimulator
- •Iron-containing foreign bodies in eyes or brain
- •Some hearing aids and artificial (heart) valves which are contraindicated for MRS
- •Claustrophobia
- •- Participants, who do not want to be informed about unexpected medical findings, or do not wish that their physician is informed, cannot participate in the study.
- •- Participants who have been involved in studies (or for medical reasons) with medical radiation (PET-CT scans)
研究者
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