NCT02561377

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 29, 2015

Status Verified

September 1, 2015

Enrollment Period

10 months

First QC Date

September 24, 2015

Last Update Submit

September 28, 2015

Conditions

Keywords

resistance trainingPrediabetic stateMetabolomics

Outcome Measures

Primary Outcomes (2)

  • glycemic control

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

    6 months

  • glycemic control

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

    12 months

Secondary Outcomes (4)

  • small molecule metabolites

    6 months

  • small molecule metabolites

    12 months

  • Incidence rate of diabetes

    6 months

  • Incidence rate of diabetes

    12 months

Study Arms (3)

resistance training

EXPERIMENTAL

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.

Behavioral: resistance training

aerobic training

EXPERIMENTAL

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.

Behavioral: aerobic training

standard care

NO INTERVENTION

standard care complied with the daily lifestyle.

Interventions

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.

resistance 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.

aerobic training

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The first Affiliated hospital of Guangxi medical university

Nanning, Guangxi, 530021, China

RECRUITING

Southeast University, China

Nanjing, Jiangsu, 210096, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 22275442BACKGROUND
  • 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.

    PMID: 20505214BACKGROUND
  • 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.

    PMID: 20433212BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Prediabetic State

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Qingqing Lou

    Nanjing University of Traditional Chinese Medicine

    STUDY DIRECTOR

Central Study Contacts

Qingqing Lou, director

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director, department of education

Study Record Dates

First Submitted

September 24, 2015

First Posted

September 28, 2015

Study Start

September 1, 2015

Primary Completion

July 1, 2016

Study Completion

September 1, 2016

Last Updated

September 29, 2015

Record last verified: 2015-09

Locations