NCT07023133

Brief Summary

Loss of body weight can elicit an adaptive decline in energy expenditure during rest and physical activity beyond what is expected based on the loss of metabolically active tissue, a phenomenon termed metabolic adaptation. The weight loss-induced decrease in energy expenditure (i.e., altered energy efficiency) can hinder continued weight loss and contributes to variation in weight loss success. The molecular mechanisms responsible for metabolic adaption include changes to sympathetic nervous system activity, decreases in leptin and thyroid hormones, and increases in skeletal muscle mitochondrial efficiency and capacity, though the dominant mechanism for metabolic adaptation is unclear. We have recently shown, using near-infrared spectroscopy (NIRS) technology, that we can non-invasively assess skeletal muscle mitochondrial efficiency (i.e., oxygen consumption rate) and capacity. The purpose of this study is to evaluate the association between skeletal muscle mitochondrial efficiency and capacity after weight loss with metabolic adaption and weight loss variability. To accomplish this aim, we will recruit individuals with obesity who have elected for bariatric surgery at local bariatric centers. We will assess their energy expenditure and mitochondrial efficiency and capacity before and after weight loss.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Jul 2025

Status
not yet recruiting

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

Study Progress54%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

June 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 28, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

1.4 years

First QC Date

June 8, 2025

Last Update Submit

June 8, 2025

Conditions

Keywords

weight lossbariatric surgery

Outcome Measures

Primary Outcomes (2)

  • Weight loss

    The degree of weight loss after bariatric surgery

    4 months

  • Mitochondrial function

    Degree of change in mitochondrial function as a result of weight loss

    4 months

Study Arms (1)

study cohort group

The study cohort will be made up of individuals that have self selected for bariatric surgery.

Behavioral: Weight loss

Interventions

Weight lossBEHAVIORAL

All participants will have self selected for bariatric surgery and their weight loss and mitochondrial function will be measured in this study.

study cohort group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with obesity that have self elected for bariatric surgery

You may qualify if:

  • obesity (BMI\>30 kg/m2); self elected for bariatric surgery

You may not qualify if:

  • body mass \> 350 pounds; presence of type 2 diabetes, thyroid disease, coronary heart disease, congenital heart disease, peripheral arterial disease; having a pacemaker; the use of a walking aid; the presence of an injury that would modify normal gait; and women who are currently pregnant or trying to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Nicolas D Knuth, Doctor of Philosophy

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 8, 2025

First Posted

June 15, 2025

Study Start

July 28, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 1 year after publication with no end date.
Access Criteria
Access to study IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Please contact corresponding author for more information or to submit a request.