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

Primary Purpose

Prediabetic State

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
resistance training
aerobic training
Sponsored by
Nanjing University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetic State focused on measuring resistance training, Prediabetic state, Metabolomics

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The first Affiliated hospital of Guangxi medical universityRecruiting
  • Southeast University, ChinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

resistance training

aerobic training

standard care

Arm Description

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 consisted of aerobic exercise and progressed from 15-20min/session at 60% maximum heart rate to 45-50min/session at 75% maximum heart rate.

standard care complied with the daily lifestyle.

Outcomes

Primary Outcome Measures

glycemic control
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 6 months.
glycemic control
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 12 months.

Secondary Outcome Measures

small molecule metabolites
Biological markers, with the method of metabolomics approach, will be measured at 6 months
small molecule metabolites
Biological markers, with the method of metabolomics approach, will be measured at 12 months.
Incidence rate of diabetes
Evaluate the incidence of diabetes in prediabetes population at 6 months.
Incidence rate of diabetes
Evaluate the incidence of diabetes in prediabetes population at 12 months.

Full Information

First Posted
September 24, 2015
Last Updated
September 28, 2015
Sponsor
Nanjing University of Traditional Chinese Medicine
Collaborators
Guangxi Medical University, Southeast University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02561377
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University of Traditional Chinese Medicine
Collaborators
Guangxi Medical University, Southeast University, China

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State
Keywords
resistance training, Prediabetic state, Metabolomics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
resistance training
Arm Type
Experimental
Arm Description
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.
Arm Title
aerobic training
Arm Type
Experimental
Arm Description
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.
Arm Title
standard care
Arm Type
No Intervention
Arm Description
standard care complied with the daily lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
resistance training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
aerobic training
Intervention Description
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.
Primary Outcome Measure Information:
Title
glycemic control
Description
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 6 months.
Time Frame
6 months
Title
glycemic control
Description
Fasting blood glucose, postprandial blood glucose and HbA1c will be measured at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
small molecule metabolites
Description
Biological markers, with the method of metabolomics approach, will be measured at 6 months
Time Frame
6 months
Title
small molecule metabolites
Description
Biological markers, with the method of metabolomics approach, will be measured at 12 months.
Time Frame
12 months
Title
Incidence rate of diabetes
Description
Evaluate the incidence of diabetes in prediabetes population at 6 months.
Time Frame
6 months
Title
Incidence rate of diabetes
Description
Evaluate the incidence of diabetes in prediabetes population at 12 months.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Lou, director
Phone
8615312019129
Email
lqq188@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Liu
Phone
8615951079021
Email
liulin163com@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingqing Lou
Organizational Affiliation
Nanjing University of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
The first Affiliated hospital of Guangxi medical university
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xia Dai, director
Phone
8613977166323
Email
daixia333@aliyun.com
Facility Name
Southeast University, China
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210096
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Ji
Phone
8613511681180
Email
1059653855@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22275442
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.
Results Reference
background
PubMed Identifier
20505214
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.
Results Reference
background
PubMed Identifier
20433212
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.
Results Reference
background
PubMed Identifier
34649825
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.
Results Reference
derived
PubMed Identifier
31737686
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.
Results Reference
derived

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

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