NCT03325933

Brief Summary

This study will investigate the relationship between resistance training load and repetitions on cardiometabolic outcomes. The primary objective of this clinical trial is to determine whether high load or low load resistance exercise training affects arterial stiffness in overweight or obese men and women. Our secondary objectives are to investigate the effects of high and low load RT on vascular function, cardiac structure, and markers of insulin sensitivity. Finally, we are going to preliminarily explore the effects of resistance training on intestinal bacteria.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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 21, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

2.9 years

First QC Date

October 13, 2017

Last Update Submit

April 14, 2021

Conditions

Keywords

insulin sensitivitymusclestrengthresistance trainingstrength trainingvascular functionarterial stiffnessglucose tolerance

Outcome Measures

Primary Outcomes (1)

  • Arterial Stiffness

    Measured via pulse wave velocity

    Change from Baseline Pulse Wave Velocity at 12 weeks

Secondary Outcomes (11)

  • Insulin Sensitivity

    Change from Baseline Matsuda Index at 12 weeks

  • Endothelial Function

    Change from Baseline %FMD at 12 weeks

  • Cardiac echocardiography

    Changes in systolic and diastolic parameters from baseline to 12 weeks

  • Isokinetic Strength

    Change from Baseline isokinetic strength at 12 weeks

  • Isometric Strength

    Change from Baseline Isometric strength at 12 weeks

  • +6 more secondary outcomes

Other Outcomes (1)

  • Maximal Oxygen Consumption

    Change from Baseline VO2peak at 12 weeks

Study Arms (3)

Resistance Training 1

EXPERIMENTAL

Participants will perform resistance training with high training loads and low repetitions (high load/low rep resistance training).

Other: High Load/Low Rep Resistance Training

Resistance Training 2

EXPERIMENTAL

Participants will perform resistance training with low training loads and high repetitions (Low load/high rep resistance training).

Other: Low Load/High Rep Resistance Training

Wait-list control

NO INTERVENTION

This group will be offered the option of participating in either experimental group after the study is completed.

Interventions

Participants will be prescribed High Load/Low Rep resistance training.

Resistance Training 1

Participants will be prescribed Low Load/High Rep resistance training.

Resistance Training 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female
  • years of age
  • BMI 25-40
  • No recent history of starting a structured exercise program or diet in the last 3 months

You may not qualify if:

  • Current smoker and/or recreational drug user
  • Answers "yes" to one or more questions on the Physical Activity Readiness Questionnaire
  • Diagnosed diabetes, heart disease
  • History of anabolic steroid use in the past six months
  • Taking medications for treatment of diabetes, heart disease, and hypertension.
  • Orthopedic or musculoskeletal contraindications to resistance training
  • Unwilling to follow any aspect of the study protocol including blood sampling and weight training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (43)

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MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Siddhartha S Angadi, PhD

    Arizona State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 13, 2017

First Posted

October 30, 2017

Study Start

September 21, 2017

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

This data will be used primarily for a doctoral dissertation project as well as manuscript publication.

Locations