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. 2017 Dec 4;2017(12):CD003054. doi: 10.1002/14651858.CD003054.pub4

PREVIEW.

Trial name or title Acronym: PREVIEW
Methods Type of study: efficacy study
Allocation: randomised
Intervention model: parallel assignment
Masking: open‐label
Primary purpose: prevention
Participants Condition: IFG or IGT (IFG: fasting venous plasma glucose concentration 5.6‐6.9 mmol/L or IGT: venous plasma glucose concentration of 7.8‐11.0 mmol/L at 2‐h after oral administration of 75 g glucose with fasting plasma glucose less than 7.0 mmol/L).
Enrollment: 2500
Inclusion criteria: age 25‐70 years; overweight or obesity (BMI > 25 kg/m2); IFG or IGT; informed consent required; provided participants have not recently (within 1 month) changed habits; motivation and willingness to be randomised to any of the groups and to do his/her best to follow the given protocol
Exclusion criteria: diabetes mellitus (other than gestational diabetes mellitus); significant cardiovascular disease including current angina; myocardial infarction or stroke within the past 6 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 last 3 months; advanced chronic renal impairment; significant liver disease e.g. cirrhosis (fatty liver disease allowed); malignancy which is currently active or in remission for < 5 years after last treatment (local basal and squamous cell skin cancer allowed); active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption; previous bariatric surgery; chronic respiratory, neurological, musculoskeletal or other disorders where, in the judgement of the investigator, participants would have unacceptable risk or difficulty in complying with the protocol (e.g. physical activity programme); a recent surgical procedure until after full convalescence (investigators judgement); transmissible blood‐borne diseases; psychiatric illness (e.g. major depression, bipolar disorder); use currently or within the previous 3 months of prescription medication that has the potential of affecting body weight or glucose metabolism such as glucocorticoids (but excluding inhaled and topical steroids; bronchodilators are allowed); psychoactive medication, epileptic medication, or weight loss medications (either prescription, over the counter or herbal). Low‐dose antidepressants are allowed if they, in the judgement of the investigator, do not affect weight or participation to the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the participant has been on a stable dose for at least 3 months; engagement in competitive sports; self‐reported weight change of > 5% (increase or decrease) within 2 months prior to screening; special diets within 2 months prior to study start; severe food intolerance expected to interfere with the study; regularly drinking > 21 alcoholic units/week (men), or > 14 alcoholic units/week (women); use of drugs of abuse within the previous 12 months; blood donation or transfusion within the past 1 month before baseline; self‐reported eating disorders; pregnancy or lactation, including plans to become pregnant within the next 36 months; no access to either phone or Internet (this is necessary when being contacted by the instructors during the maintenance phase); adequate understanding of national language; psychological or behavioural problems which, in the judgement of the investigator, would lead to difficulty in complying with the protocol; haemoglobin concentration below local laboratory reference values (i.e. anaemia); creatinine > 1.5 times Upper Limit of Normal (local laboratory reference values); alanine transaminase and/or aspartate transaminase > 3 times the Upper Limit of Normal (local laboratory reference values) or any other significant abnormality on these tests which in the investigators opinion may be clinically significant and require further assessment; electrocardiography. Any abnormality which in the opinion of the investigator might indicate undiagnosed cardiac disease requiring further assessment (e.g. significant conduction disorder, arrhythmia, pathological Q waves). This is done in adults 55‐70 years of age.
Interventions Intervention(1): high protein/high‐intensity physical activity
Intervention(2): high protein/moderate‐intensity physical activity
Intervention(3): moderate protein/high‐intensity physical activity
Intervention(4): moderate protein/moderate‐intensity physical activity
Comparator(s): participants follow a moderate protein diet and moderate‐intensity physical activity intervention
Duration of the intervention: 3 years
Outcomes Primary outcome(s): incidence of T2DM
Secondary outcome(s): HbA1c; change in body weight and waist, hip and thigh circumference; change in body fat mass (kg, proportion of body weight); proportion of participants maintaining at least 0%, 5% or 10% weight loss (relative to initial body weight); insulin sensitivity; risk factors for cardiovascular disease, with at least the following measures: blood pressure, lipids (triglycerides, total, low‐density lipoprotein and high‐density lipoprotein cholesterol), C‐reactive protein, and liver enzymes; changes in perceived quality of life and work ability, habitual well‐being, sleep and chronic stress, subjective appetite sensations, and habitual physical activity; the effects of stature (height; proportion leg‐length/height) in adults and changes in stature in children and adolescents, on the changes in relationship between reduction in body weight, body fat and insulin sensitivity
Other outcome(s): ‐
Starting date Study start date: June 2013
Study completion date: December 2018
Contact information Responsible party/principal investigator: Anne Birgitte Raben, Professor, University of Copenhagen
Study identifier NCT number: NCT01777893
Official title PREVention of Diabetes Through Lifestyle Intervention and Population Studies in Europe and Around the World
Stated purpose of study Quote: "Our hypothesis is that a high‐protein, low‐GI diet will be superior in preventing type‐2 diabetes, compared with a moderate protein, moderate GI diet, and that high‐intensity physical activity will be superior compared to moderate‐intensity physical activity"
Notes