Status:
COMPLETED
P4 Approach in Diabetes Type 2
Lead Sponsor:
W.J. Pasman
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-80 years
Phase:
NA
Brief Summary
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 characteristic...
Detailed Description
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 inv...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02196350
Start Date
September 1 2014
End Date
July 1 2019
Last Update
October 25 2019
Active Locations (9)
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1
Huisartsenpraktijk Lommelaars
Hillegom, South Holland, Netherlands, 2181 EK
2
Huisartspraktijk C.C. Dekker
Hillegom, South Holland, Netherlands, 2181 EN
3
Huisartspraktijk Tubbergen
Hillegom, South Holland, Netherlands, 2181 EN
4
Huisartsenpraktijk Sixlaan 9
Hillegom, South Holland, Netherlands, 2182 AA