Sub-Study of the PREVIEW Study Australia (NCT02030249) | Clinical Trial Compass
UnknownNot Applicable
Sub-Study of the PREVIEW Study Australia
Australia292 participantsStarted 2014-01
Plain-language summary
The aim of this study is to investigate possible enduring effects of a standard 2-month weight loss program on appetite regulation, bone homeostasis and muscle strength in younger and older adults, as well as the impact of differences in dietary composition during weight maintenance.
Who can participate
Age range25 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 25 - 45 years and 55 - 70 years
* Overweight or obesity status BMI\>25 kg/m2
* Pre-diabetes. The criteria from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes will be used as the formal inclusion criteria, i.e. having: Impaired Fasting Glucose (IFG): Fasting venous plasma glucose concentration 5.6 - 6.9 mmol/l or Impaired Glucose Tolerance (IGT): Venous Plasma glucose concentration of 7.8 - 11.0 mmol/l at 2 h after oral administration of 75 g glucose (oral glucose tolerance test, OGTT), with fasting plasma glucose less than 7.0 mmol/l. Due to potential between-lab variation (local assessments), HbA1c is not used as an inclusion criteria in the screening.
* Informed consent required
* Ethnic group - No restrictions
* Smoking - Smoking is allowed, provided subjects have not recently (within 1 month) changed habits. However, smoking status is monitored throughout the study and used as a confounding variable.
* Motivation - Motivation and willingness to be randomized to any of the groups and to do his/hers best to follow the given protocol
* Other - Able to participate at CID's during normal working hours.
Exclusion Criteria:
Based on interview and/or questionnaire, individuals with the following problems will be excluded:
* Medical conditions as known by the subjects: Diabetes mellitus (other than gestational diabetes mellitus); Significant cardiovascular disease including current angina; myocardial infarction or stroke within…