NCT04865965

Brief Summary

The purpose of this study is to determine the effects of a single bout of exercise on changes in the genes and small molecules in blood and fat tissue, before and after a bout of exercise. This research may contribute to a better understanding of the beneficial effects of exercise on the body.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2021

Typical duration for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2024

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

3 years

First QC Date

April 13, 2021

Last Update Submit

February 21, 2025

Conditions

Keywords

adipose tissue transcriptomicsadipose tissue metabolomicsperipheral blood mononuclear cell transcriptomicsobesityexercise

Outcome Measures

Primary Outcomes (2)

  • Transcriptome in white adipose tissue

    Gene transcription changes in RNA-based expression within subcutaneous adipose tissue

    Baseline; 2 hours

  • Metabolome in fat

    Changes in concentration of metabolites within subcutaneous adipose tissue

    Baseline; 2 hours

Secondary Outcomes (1)

  • Transcriptomic changes in peripheral blood mononuclear cell in people with obesity

    Baseline; 2 hours

Study Arms (2)

Acute Bout of Exercise

EXPERIMENTAL

Exercising for 60 minutes at 55-60% of VO₂ peak

Procedure: Acute Bout of Exercise

No Exercise

NO INTERVENTION

No Exercise Session

Interventions

Exercising for 60 minutes at 55-60% of VO₂ peak

Acute Bout of Exercise

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-60 years
  • Body mass index (BMI) ≥30.0 ± 0.1 and ≤40.0 ± 0.1 kg/m2
  • HbA1c ≤ 5.7 ± 0.1%
  • No history of diabetes (type 1 and type 2)
  • In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
  • Willing to adhere to the protocol requirements for the duration of the study

You may not qualify if:

  • Exercises frequently i.e. ≥ 150 minutes per week of moderate intensity or ≥ 75 min high intensity.
  • Blood glucose rises ≥140mg/dl at 2 hours after OGTT on Visit 1
  • Use of weight loss medications (i.e. GLP-1 agonists)
  • Use of any medications related to diabetes
  • Use of beta-blockers
  • Use of anticoagulation and aspirin
  • Use of agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives
  • Currently pregnant or breastfeeding
  • Current smoker
  • Heart or lung disease
  • Acute infection, including COVID-19 (current or recent infection of COVID-19 in the previous 3 months)
  • Any hospitalization due to COVID-19.
  • Severe hypertension (systolic \>160 mmHg or diastolic \>90 mmHg)
  • Inability to exercise for any reason
  • Any known contraindication to exercise testing based on current ACSM guidelines (5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Roeland JW Middelbeek, MD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR
  • Laurie Goodyear, PhD

    Joslin Diabetes Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 29, 2021

Study Start

May 27, 2021

Primary Completion

May 23, 2024

Study Completion

May 23, 2024

Last Updated

February 24, 2025

Record last verified: 2025-02

Locations