NCT03162991

Brief Summary

Overview- In this study, overweight or obese, sedentary participants (age=35-55 years, n=20) will be randomized to a 12-week control period or an aerobic exercise intervention. Those randomized into the control group will then complete the exercise intervention subsequently. The planned energy expenditure per week of exercise will be 10-12 kilocalories per kilogram of body weight per week. Participants will complete three non-consecutive exercise sessions per week. Body weight, resting metabolic rate via indirect calorimetry, peak oxygen consumption (VO2peak) through graded exercise testing, fasting blood samples, CGM, sleep and dietary habits via self-report, and physical activity monitoring will be completed at prior to and following the aerobic exercise intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

November 13, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

May 19, 2017

Last Update Submit

April 16, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • Continuous Glucose Monitoring

    Fasting, Postprandial, and Matched Time Point Glucose Measurements

    3-6 months

  • Glucose Regulatory Hormones

    Fasting blood concentrations of Glucose Regulatory Hormones

    3-6 months

Study Arms (2)

12-Week Aerobic Exercise Intervention

EXPERIMENTAL
Other: Aerobic Exercise Intervention

12-Week Control Period

NO INTERVENTION

Interventions

Aerobic Exercise Intervention- 12-weeks, exercise 3 non-consecutive days/week for \~30-55 minutes per exercise session.

12-Week Aerobic Exercise Intervention

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • be age 35-55 years of age,
  • have 25≤body mass index (BMI)≤40 kg/m2,
  • be weight stable (±2%) during the previous 3 months,
  • have ˂120 minutes of resistance or endurance exercise per week during the previous 3 months, and
  • for females, be eumenorrheic, or post-menopausal for ≥1 year.

You may not qualify if:

  • self-reported medical conditions (e.g. diabetes), cardiovascular diseases, chronic or recurrent respiratory conditions (e.g. uncontrolled asthma or chronic obstructive pulmonary disease), active cancer, and eating, or neurological disorders,
  • medications that affect metabolism (e.g. thyroid medications, statins),
  • psychological issues, including but not limited to untreated depression and attention deficit disorder,
  • excessive caffeine use (\>500 mg/day),
  • smoking during the past year,
  • pregnant or lactating females,
  • unwillingness to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Public Health Research Center

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Glucose Metabolism DisordersMotor ActivitySedentary Behavior

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate; Graduate/Research Assistant

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 22, 2017

Study Start

November 13, 2017

Primary Completion

April 15, 2019

Study Completion

April 15, 2019

Last Updated

April 18, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations