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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02561377
Other study ID # 81370923
Secondary ID
Status Recruiting
Phase N/A
First received September 24, 2015
Last updated September 28, 2015
Start date September 2015
Est. completion date September 2016

Study information

Verified date September 2015
Source Nanjing University of Traditional Chinese Medicine
Contact Qingqing Lou, director
Phone 8615312019129
Email lqq188@yahoo.com
Is FDA regulated No
Health authority China: National Natural Science Foundation
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 276
Est. completion date September 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 45 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
resistance training
Resistance training consisted of 6 different resistance exercises per session using elastic string, and each exercise progressed to 2-3 at maximum resistance lifted 8-10 times.
aerobic training
Aerobic training consisted of aerobic exercise and progressed from 15-20min/session at 60% maximum heart rate to 45-50min/session at 75% maximum heart rate.

Locations

Country Name City State
China Southeast University, China Nanjing Jiangsu
China The first Affiliated hospital of Guangxi medical university Nanning Guangxi

Sponsors (3)

Lead Sponsor Collaborator
Nanjing University of Traditional Chinese Medicine Guangxi Medical University, Southeast University, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View Citation

Morrison F, Shubina M, Turchin A. Lifestyle counseling in routine care and long-term glucose, blood pressure, and cholesterol control in patients with diabetes. Diabetes Care. 2012 Feb;35(2):334-41. doi: 10.2337/dc11-1635. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary glycemic control Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 6 months. 6 months No
Primary glycemic control Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 12 months. 12 months No
Secondary small molecule metabolites Biological markers, with the method of metabolomics approach, will be measured at 6 months 6 months No
Secondary small molecule metabolites Biological markers, with the method of metabolomics approach, will be measured at 12 months. 12 months No
Secondary Incidence rate of diabetes Evaluate the incidence of diabetes in prediabetes population at 6 months. 6 months No
Secondary Incidence rate of diabetes Evaluate the incidence of diabetes in prediabetes population at 12 months. 12 months No
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