Status:
COMPLETED
Early Diagnosis of Diabetes Mellitus Type 2 (DM2)
Lead Sponsor:
TNO
Collaborating Sponsors:
Netherlands: Ministry of Health, Welfare and Sports
Conditions:
Impaired Blood Glucose Level
Overweight
Eligibility:
MALE
30-70 years
Brief Summary
Rationale: The global prevalence of diabetes, along with its devastating effects on life expectancy and quality of life, continues to increase. Worldwide, the total number of people with diabetes is p...
Detailed Description
Rationale: The global prevalence of diabetes, along with its devastating effects on life expectancy and quality of life, continues to increase. Worldwide, the total number of people with diabetes is p...
Eligibility Criteria
Inclusion
- Healthy as assessed by the
- health and lifestyle questionnaire, (P7348 F02; in Dutch)
- physical examination
- results of the pre-study laboratory tests
- Males aged between 30 and 70 years at Day 01 of the study
- Body Mass Index (BMI) between 26 and ≤ 35 kg/m2
- Pre-diabetic as established by fasting glucose 6.1 to 6.9 mmol/L
- Normal Dutch eating habits as assessed by P7348 F02
- Voluntary participation
- Having given written informed consent
- Willing to comply with the study procedures
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
Exclusion
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- Having a history of medical or surgical events that may significantly affect the study outcome
- Medication use
- Smoking
- Alcohol consumption \> 28 units/week
- Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
- Reported slimming or medically prescribed diet
- Reported vegan, vegetarian or macrobiotic
- Acupuncture treatment or use of TCM
- 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 Quality of Life, their partner and their first and second degree relatives
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding his/her 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 :
June 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00469287
Start Date
June 1 2007
End Date
June 1 2007
Last Update
April 7 2008
Active Locations (1)
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1
Metabolic ward of TNO Quality of Life
Zeist, Utrecht, Netherlands, 3700AJ