Clinical trial NCT02561377: Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics)
Official title: Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prediabetic State
Keywords: resistance training
Prediabetic state
Metabolomics
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Guangxi Medical University
name: Southeast University, China
First posted: 2015-09-28
Enrollment: 276
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the efficacy of a 12-month resistance training on metabolic control and reducing the risk of diabetes.

Detailed description: Most of exercise interventions involved aerobic exercises, investigators were not able to find a single long term study focusing on type 2 diabetes prevention with resistance training and aerobic exercise. It has been known that for those who have already had diabetes, resistance training can reduce insulin resistance and HbA1c level, improve lipid profile, and decrease blood pressure. Based on previous findings, investigators will evaluate how the different exercising interventions impact on insulin resistance, metabolic control, and the incidence and prevalence of diabetes in prediabetes population who receive 12 months of either resistant training or aerobic exercise. Further more, metabolomics approach will be introduced to detect biological markers,and therefore,to analyze the predictive values of metabolomics on long term outcomes of prediabetes population.

Eligibility criteria: Inclusion Criteria:

* a confirmed diagnosis of prediabetes according to the American Diabetes Association (ADA) guidelines
* level 4 of muscle strength
* willingness to accept exercise intervention
* provision of written informed consent.

Exclusion Criteria:

* type 2 or other types of diabetes
* women who are pregnant
* hepatic dysfunction, as evidenced by alanine aminotransferase (ALT) or alkaline phosphatase (ALP) levels greater than 2.5-fold the upper limits of normal
* crucial organ failure or other severe diseases, including myocardial infarction
* malignancy

Primary outcomes:
measure: glycemic control
timeFrame: 6 months
measure: glycemic control
timeFrame: 12 months
Secondary outcomes:
measure: small molecule metabolites
timeFrame: 6 months
measure: small molecule metabolites
timeFrame: 12 months
measure: Incidence rate of diabetes
timeFrame: 6 months
measure: Incidence rate of diabetes
timeFrame: 12 months
Other outcomes:
Locations:
city: Nanning
country: China
facility: The first Affiliated hospital of Guangxi medical university
state: Guangxi
city: Nanjing
country: China
facility: Southeast University, China
state: Jiangsu
Study officials:
affiliation: Nanjing University of Traditional Chinese Medicine
name: Qingqing Lou
role: STUDY_DIRECTOR
References:
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citation: Lewis GD, Farrell L, Wood MJ, Martinovic M, Arany Z, Rowe GC, Souza A, Cheng S, McCabe EL, Yang E, Shi X, Deo R, Roth FP, Asnani A, Rhee EP, Systrom DM, Semigran MJ, Vasan RS, Carr SA, Wang TJ, Sabatine MS, Clish CB, Gerszten RE. Metabolic signatures of exercise in human plasma. Sci Transl Med. 2010 May 26;2(33):33ra37. doi: 10.1126/scitranslmed.3001006.
citation: Strasser B, Siebert U, Schobersberger W. Resistance training in the treatment of the metabolic syndrome: a systematic review and meta-analysis of the effect of resistance training on metabolic clustering in patients with abnormal glucose metabolism. Sports Med. 2010 May 1;40(5):397-415. doi: 10.2165/11531380-000000000-00000.
citation: Chen X, Zhao S, Hsue C, Dai X, Liu L, Miller JD, Fang Z, Feng J, Huang Y, Wang X, Lou Q. Effects of aerobic training and resistance training in reducing cardiovascular disease risk for patients with prediabetes: A multi-center randomized controlled trial. Prim Care Diabetes. 2021 Dec;15(6):1063-1070. doi: 10.1016/j.pcd.2021.08.013. Epub 2021 Oct 11.
citation: Yan J, Dai X, Feng J, Yuan X, Li J, Yang L, Zuo P, Fang Z, Liu C, Hsue C, Zhu J, Miller JD, Lou Q. Effect of 12-Month Resistance Training on Changes in Abdominal Adipose Tissue and Metabolic Variables in Patients with Prediabetes: A Randomized Controlled Trial. J Diabetes Res. 2019 Oct 16;2019:8469739. doi: 10.1155/2019/8469739. eCollection 2019.