Diabetes type 2
Conditions
Interventions
Prediabetics and newly diagnosed type 2 diabetics are presented the choice of
participating in the P4 program. After investigation of the status of the
different organs involved in diabetes, subject
Sponsors
TNO
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Healthy as assessed by the - health and lifestyle questionnaire, (P9607 F02; in Dutch) - physical examination - results of the pre-study laboratory tests 2. Age 30-80 years 3. Stable BMI 25-35 kg/m2 4. 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 or preidabetes (fasting glucose between 6.1-6.9 mmol/L) 5. Duration of diabetes maximally 1 year 6. Informed consent signed; 7. Willing to comply with the study procedures during the study; 8. Appropriate veins for blood sampling/ cannula insertion according to the general practitioner assistant (GPA); 9. Voluntary participation 10. Physically able to perform training activities 11. 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 criteria
Exclusion criteria: 1. Use of insulin, corticosteroids (systemic), or beta-blockers in past month 2. Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes 3. Slow onset type 1 4. Use of oral diabetes medication in past year 5. (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. 6. Hypertension: systolic blood pressure >160 mmHg, diastolic blood pressure >90 mmHg 7. Kidney problems based upon proteinuria and creatinine >150 mmol/l 8. Physical activity higher than according to the Diabetes guidelines(1 hour a day) 9. Alcohol consumption > 21 (women) - 28 (men) units/week 10. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening 11. Recent blood donation (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A diversity of parameters related to glucose metabolism will be measured before and after the three month intervention period. Primary study parameters will be HbA1c, fasting plasma glucose (FPG), 2h glucose after oral glucose tolerance test (OGTT). | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition, diabetes medication, quality of life (QoL) and lifestyle questionnaires, lipid profile, blood pressure, body weight (BW), waist circumference (WC), body mass index (BMI), body fat%, and indices for beta cell function, hepatic insulin resistance and muscle insulin resistance during OGTT will be determined as secondary study parameters. Finally, the number of participants that reach normoglycemia (fasting blood glucose level of less than 6.1 mmol/L ) will be determined as derivative of the fasting blood glucose for each subject at the end of the study (wk 13) as well as after two years of follow-up. | — |
Countries
Netherlands
Outcome results
None listed