NCT01511276 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

de Roon M, van Gemert WA, Peeters PH, Schuit AJ, Monninkhof EM
Long-term effects of a weight loss intervention with or without exercise component in postmenopausal women: A randomized trial. Prev Med Rep. 2016 Dec 9;5:118-123. eCollection 2017 Mar.
van Gemert WA, Iestra JI, Schuit AJ, May AM, Takken T, Veldhuis WB, van der Palen J, Wittink H, Peeters PH, Monninkhof EM
Design of the SHAPE-2 study: the effect of physical activity, in addition to weight loss, on biomarkers of postmenopausal breast cancer risk. BMC Cancer. 2013 Aug 23;13:395. doi: 10.1186/1471-2407-13-395.
van Gemert WA, May AM, Schuit AJ, Oosterhof BY, Peeters PH, Monninkhof EM
Effect of Weight Loss with or without Exercise on Inflammatory Markers and Adipokines in Postmenopausal Women: The SHAPE-2 Trial, A Randomized Controlled Trial. Cancer Epidemiol Bi
van Gemert WA, Schuit AJ, van der Palen J, May AM, Iestra JA, Wittink H, Peeters PH, Monninkhof EM
Effect of weight loss, with or without exercise, on body composition and sex hormones in postmenopausal women: the SHAPE-2 trial. Breast Cancer Res. 2015 S
van Gemert WA, van der Palen J, Monninkhof EM, Rozeboom A, Peters R, Wittink H, Schuit AJ, Peeters PH
Quality of Life after Diet or Exercise-Induced Weight Loss in Overweight to Obese Postmenopausal Women: The SHAPE-2 Randomised Controlled Trial. PLoS On

The Effects of Equivalent Weight Loss With or Without Exercise Training on Breast Cancer Risk Biomarkers in Postmenopausal Women: the SHAPE-2 Study

Clinical trial NCT01511276 - References