The Probiotics Prevention Diabetes Programme has received financial support from governmental funding. Funding of RMB 300 thousand from the Science and Technology Commission of Shanghai Municipality (134119a3300) covers the cost of the study from June 2013–June 2016. Funding of RMB 170 thousand from the Project of Science and Technology of Pudong Health and Family Planning Commission of Shanghai (Grant No. PKJ2014-Y13) covers the programme delivery from October 2014 to October 2017. Further support from the Key Specialty Construction Project of Pudong Health and Family Planning Commission of Shanghai (Grant No. PWZz2013-04) provided RMB 300 thousand to cover the programme delivery and trial recruitment in community.
Bo Feng is the principal investigator (PI). He designed the study and will oversee the project implementation, train researchers and doctoral students, participating in data collection, analyses and interpretation and writing publications. Qun Yan and Xu Li participate in study design and will implement the designed protocol, participating in supervise students, data collection, data analyses and interpretation and writing publications. All authors read and approved the final manuscript.
Alterations in intestinal microbiota correlate with risk of development of obesity and type 2 diabetes. Probiotics have been suggested to play an important role in the management of dysglycemia, although the evidence is limited. In this study, we aim to explore the efficacy and safety of probiotics intervention in preventing type 2 diabetes in Chinese patients with impaired glucose tolerance.
A 24-month randomized intervention is conducted from January 2014 to December 2016. The target sample size for intervention is 200 middle-aged men and women aged 30–65 year-old with impaired glucose tolerance. Participants with persistent impaired glucose tolerance were assigned to group A (tablet A) and B (tablet B) in sequential order. The participants and investigators were blinded to the assignment. The primary outcome is development of diabetes. The secondary outcome measures include body composition, biochemical variables and the safety of the probiotics.
The results from this trial will provide the evidence on the efficacy and safety of probiotics administration in preventing conversion of impaired glucose tolerance to diabetes in a Chinese context.
DREAM (Diabetes REduction Assessment with ramipril and rosiglitazone Medication) Trial Investigators, Gerstein HC, Yusuf S, Bosch J, Pogue J, Sheridan P, et al. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomized controlled trial. Lancet. 2006;368:1096–105. CrossRef
Lindsay KL, Brennan L, Kennelly MA, Maguire OC, Smith T, Curran S, et al. Impact of probiotics in women with gestational diabetes mellitus on metabolic health: a randomized controlled trial. Am J Obstet Gynecol. 2015;212:496.e1-11. PubMed
Qian Q, Li X, Huang X, Fu M, Meng Z, Chen M, et al. Glucose metabolism among residents in Shanghai: natural outcome of a 5-year follow-up study. J Endocrinol Invest. 2012;35:453–8. PubMed
- The efficacy and safety of probiotics intervention in preventing conversion of impaired glucose tolerance to diabetes: study protocol for a randomized, double-blinded, placebo controlled trial of the Probiotics Prevention Diabetes Programme (PPDP)
- BioMed Central
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