CRDA: Other Outcomes (2023)
Author and Year:
Raben A, Vestentoft P, Brand-Miller J, et al. 2021
PubMed ID:
Article Title:
The PREVIEW intervention study: Results from a 3-year randomized 2 x 2 factorial multinational trial investigating the role of protein, glycaemic index and physical activity for prevention of type 2 diabetes.
Authors:
Raben A, Vestentoft P, Brand-Miller J, Jalo E, Drummen M, Simpson L, Martinez J, Handjieva-Darlenska T, Stratton G, Huttunen-Lenz M, Lam T, Sundvall J, Muirhead R, Poppitt S, Ritz C, Pietiläinen K, Westerterp-Plantenga M, Taylor M, Navas-Carretero S, Handjiev S, McNarry M, Hansen S, Råman L,Brodie S, Silvestre M, Adam T, Macdonald I, San-Cristobal R, Boyadjieva N, Mackintosh K, Schlicht W, Liu A, Larsen T, Fogelholm M
Journal:
Diabetes, Obesity & Metabolism
Year of publication:
2021
Volume:
23
Issue:
2
Page numbers:
324-337
Study Design:
Randomized Controlled Trial
Risk of Bias Assessment Rating:
Some concerns
Inclusion Criteria:
Men and women; age 25 - 70 years: from mid 2013 - mid 2014, subjects aged 25-45 and 55-70 years were enrolled. From mid 2014, subjects aged 46-54 years were also enrolled. Overweight or obesity status BMI>25 kg/m2; pre-diabetes using criteria from WHO/IDF (International Diabetes Foundation) for assessing pre-diabetes: Impaired Fasting Glucose): fasting venous plasma glucose concentration 5.6 - 6.9 mmol/l or Impaired Glucose Tolerance: 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), with fasting plasma glucose less than 7.0 mmol/l. Informed consent
Exclusion Criteria:
Diabetes mellitus (other than gestational diabetes mellitus); use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism; self-reported weight change of >5 % (increase or decrease) within 2 months prior to screening; significant cardiovascular disease including current angina; myocardial infarction or stroke within the past six months; heart failure; symptomatic peripheral vascular disease; systolic blood pressure above 160 mmHg and/or diastolic blood pressure above 100 mmHg whether on or off treatment for hypertension. If being treated, no change in drug treatment within the last three months.
Advanced chronic renal impairment Significant liver disease, e.g., cirrhosis (fatty liver disease allowed); failure to reach at least 8% weight reduction during the low calorie diet phase leading to exclusion from the intervention.
Research Purpose:
To compare the impact of two long-term weight-maintenance diets, a high protein (HP) and low glycemic index (GI) diet versus a moderate protein (MP) and mod- erate GI diet, combined with either high intensity (HI) or moderate intensity physical activity (PA), on the incidence of type 2 diabetes after rapid weight loss.
Blinding efforts:
Study Location:
Australia, Bulgaria, Denmark, Finland, Netherlands, New Zealand, Spain, United Kingdom
Source(s) of Funding:
Government, Industry, University/Hospital
Please specify names of funders:
See extensive list in reviewer comments