The Impact of the P4 Approach, Preventive, Predictive, Personalized and Participatory in Newly Diagnosed Type 2 Diabetics in Hillegom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- Change in fasting blood glucose levels
研究概览
简要总结
The study aims to assess the impact of the P4 approach on established markers of glucose metabolism in type 2 diabetics.
Secondary objectives are examination of the changes in physical characteristics, quality of life and the indices for beta cell function, hepatic insulin resistance and muscle insulin resistance .
详细描述
This study will be a proof-of-principle exploratory study. Subjects in the P4 program will receive a personalized diagnosis and treatment. After investigation of the status of the different organs involved in diabetes (liver, muscle, pancreas), subjects in the P4 group are divided into 3 subgroups. Each subgroup receives a personalized lifestyle advice. This lifestyle advice may comprise different interventions, i.e. very low calorie diet, low calorie diet, strength training, endurance training. Dependent on the type of intervention, these interventions will be supervised by a dietitian or physiotherapist.
All subjects will visit a central study center 5 times during the study and 3 times during follow-up. During these visits physical measures will be taken and data will be collected by the general practitioner assistant.
After the three month intervention period the subjects will return to usual care via the general practitioner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy as assessed by the
- •health and lifestyle questionnaire, (P9607 F02; in Dutch)
- •physical examination
- •results of the pre-study laboratory tests
- •Age 30-80 years
- •Stable BMI 25-35 kg/m2
- •Diagnosis diabetes type 2 based upon:
- •Fasting glucose >6.9 mmol/l on two different days or one measurement of non-fasting glucose >11.0 mmol/l in combination with symptoms of hyperglycemia
- •Duration of diabetes maximally 1 year
- •Informed consent signed;
- •Willing to comply with the study procedures during the study;
- •Appropriate veins for blood sampling/ cannula insertion according to the general practitioner assistant (GPA);
- •Voluntary participation
- •Physically able to perform training activities
- •Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.
排除标准
- •Use of insulin, corticosteroids (systemic), or beta-blockers in past month
- •Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes
- •Slow onset type 1 diabetes
- •Use of oral diabetes medication in past year
- •(Having a history of a) medical condition that might significantly affect the study outcome as judged by the medical investigator and health and life style questionnaire. This includes diabetes type 1, gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder.
- •Hypertension: systolic blood pressure >160 mmHg, diastolic blood pressure >90 mmHg
- •Kidney problems based upon proteinuria and creatinine >150 mmol/l
- •Insufficient beta cell function based on Disposition index < 1.5 as determined during the OGTT in study on day 01*
- •Physical activity higher than according to the Diabetes guidelines (moderate intensity one hour a day, seven days a week (overweight adults))
- •Alcohol consumption > 21 (women) - 28 (men) units/week
- •Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- •Recent blood donation (<1 month prior to the start of the study)
- •Not willing to give up blood donation during the study
- •Personnel of TNO and their partner
- •Not having a general practitioner
- •Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
研究组 & 干预措施
Intervention A: Diet
Intervention A: One week of very low calorie diet, 12 weeks of low calorie diet; exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen).
干预措施: Intervention A: Diet (Behavioral)
Intervention B: Exercise
Intervention B: Combination of strength and endurance training, 3 x per week 60 minutes according to the Exercise Program Diabetes (Beweegprogramma Diabetes).
Healthy isocaloric diet.
干预措施: Intervention B: Exercise (Behavioral)
Intervention C: Diet and Exercise
Intervention C: one week very low calorie diet, followed by 12 weeks healthy isocaloric diet.
One week exercise according to the Dutch Norm for Healthy Behaviour (Nederlandse Norm Gezond Bewegen) followed by 12 weeks strength and endurance training (3 x per week 60 minutes) according to the Exercise Program Diabetes (Beweegprogramma Diabetes)
干预措施: Intervention C: Diet and Exercise (Behavioral)
Control - Historical data
Historical data from the GPs Information System from 60 newly diagnosed type 2 diabetes patients in the last five years will be used as control.
结局指标
主要结局
Change in fasting blood glucose levels
时间窗: In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months
After 8 hour fasting. Changes in primary outcome measures will be determined by using a mixed model.
percentage of participants that reach normoglycemia
时间窗: end of study (after 13 weeks)
normoglycemia is determined by fasting blood glucose level of less than 6.1 mmol/L
Change in HbA1c levels
时间窗: In-study at week 0 (baseline) and 13 (end of study); follow-up after 6, 12 and 24 months
Changes in primary outcome measures will be determined by using a mixed model
Change in 2h glucose levels
时间窗: In-study at week 0 (baseline) and 13;
2h glucose will be measured after Oral Glucose Tolerance Test (OGTT). Changes in primary outcome measures will be determined by using a mixed model
次要结局
- body weight(screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months)
- change indices for muscle insulin resistance(screening; in-study at week 0 and 13;)
- health behaviour change(in-study at week 0, 13; during follow-up at 6, 12 and 24 months)
- change in vitality as assessed with a vitality questionnaire (Vita-16)(in-study at week 0, 13; during follow-up at 6, 12 and 24 months)
- change in indices for beta cell function(screening; in-study at week 0 and 13;)
- blood pressure(screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months)
- waist circumference(screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months)
- body fat percentage(screening; in-study at week 0, 4, 8 and 13; during follow up after 6, 12 and 24 months)
- change in subjective quality of life as assessed with RAND-36 questionnaire(in-study at week 0, 13; during follow-up at 6, 12 and 24 months)
- change in indices for hepatic insulin resistance(screening; in-study at week 0 and 13;)
研究者
W.J. Pasman
PhD
TNO