Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics)

Prediabetic State Clinical Trial

Official title:

Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02561377
• Other study ID #: 81370923
• 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

• Prediabetic State

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