Weight LossWLMFNCT07023133
Impact of Weight Loss on Mitochondrial Function
An observational study of Weight Loss and Bariatric Surgery, run by Towson University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss, Bariatric Surgery
- What is being tested?
- Weight loss
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with obesity that have self elected for bariatric surgery
Who may be able to join
- obesity (BMI>30 kg/m2); self elected for bariatric surgery
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The procedures for this study involve two visit, one before bariatric surgery and one approximately 4 months after surgery, to our laboratory. The specific tests performed are listed below and are the same for each visit (each visit will take about 2 hours). Participants will be asked to arrive dressed in loose-fitting shorts that allow for assessments to be done on the lower leg.
Upon receipt of a signed consent form, a Demographics and Health History survey will be emailed to participants. Participants will be asked to complete the questionnaire in advance of their first in-person visit and will not be repeated at the second visit. The questionnaire will take ~10 minutes to complete and will be used to document any health conditions and medications.
Upon arrival for their in-person visit, we will measure the participant's seated blood pressure and heart rate as well as height and weight to calculate their body mass index (BMI). The following tests will then be performed:
- Body Composition measurement: A DEXA scan will be performed while the participant lays on their back. A separate risk acknowledgment form for the DXA scan will be provided. Female participants of childbearing age who believe they may be pregnant or are not sure, will be offered a free pregnancy test prior to the DEXA scan.
- Blood pressure (SphygmoCor) measurement: An automated pressure cuff will be placed on the participant's upper arm and inflated.
- Resting whole-body metabolism. This assessment measures the amount of energy the body needs at rest (i.e., resting metabolic rate) to maintain normal bodily function and will take approximately 20 minutes. Participants will be asked to lie down and rest quietly while their expired breath, collected via an open hood worn over the head, will be analyzed for oxygen and carbon dioxide content to assess their resting metabolic rate.
- Resting muscle metabolism: Muscle metabolism will be measured using near-infrared spectroscopy (NIRS), which is the typical use of the NIRS device. Specifically, a small mark will be placed on the center of the tibialis anterior (TA) muscle on the front of the dominant lower leg. An ultrasound machine will be used over the marked site on their muscle to capture an image and calculate the thickness of the TA muscle as well as the fat and skin layer over the muscle. Next, a small NIRS probe will be placed over the mark and secured into place with flexible wrap to minimize movement. There is no known risk associated with the NIRS device beyond potential irritation of the skin akin to the placement of any plastic device on the skin. NIRS measurements will be collected continuously through the duration of the test using blue-tooth. Small adhesive electrical stimulation pads will be placed on the TA muscle above and below the probe. A pneumatic blood pressure cuff will be placed around the thigh (upper leg) of their dominant leg just above the knee. The testing protocol will begin with resting measures that include 3 x 30s occlusions of the leg in which the blood pressure cuff will be inflated between 250-300mmHg. This will be followed by 30s stimulation of the muscle to mimic "exercise" to the TA muscle using electrical stimulation and then a series of short (6 x 5s) occlusions of the leg in which the blood pressure cuff will be again inflated between 250-300mmHg. The intensity of electrical stimulation is moderate and produces a tingling sensation and twitching of the muscle but is not painful. It provides a standardized muscle movement that mimics tapping of one's foot. This test will be repeated 4 times. When the repetitions are complete, the test will end with 5-minutes of blood pressure cuff occlusion and 3 minutes of data collection after the cuff is released.
- Walking metabolism measurement: Participant's customary walking speed and metabolic cost (i.e. rate of oxygen consumption) will be measured at the level of the whole-body and at the level of the muscle during a 5-minute walking test performed over a 20-meter course. Distance traveled during the 5 minutes will be used to calculate their walking speed. Whole-body metabolic cost will be calculated from the measurement of oxygen consumption and carbon dioxide production rates while walking using a COSMED indirect calorimeter device. Specifically, participants will walk while wearing a facemask (for collection of expired breath) connected to the COSMED device harnessed to their back. The COSMED and harness weigh less than 3 pounds. Muscle oxygen consumption rate (i.e., metabolic cost) while walking will be measured using the NIRS device previously placed on the TA muscle. A pneumatic blood pressure cuff will be placed around the thigh (upper leg) of their dominant leg just above the knee and inflated between 250-300 mmHg for 10 seconds at the end of the walking to allow for measurement of muscle oxygen consumption rate during the occlusion. Participants will also wear a polar hear rate monitor around their chest for measurement of heart rate while walking; heart rate will be recorded by the COSMED device via Bluetooth. These measures are painless and non-invasive. Given that participants will walk at their normal, customary gait speed, no screening for any medical conditions will be used for exclusion beyond those listed above. There is no risk beyond that risk associated with normal ambulation given the self-selected walking speed.
- Physical activity level. Objective daily physical activity data will be collected using a wrist-worn accelerometer. At the end of their visit, participants will be fitted with this watch-like device that is worn at the wrist, wear it for seven consecutive days.
- Conditions
- Weight Loss, Bariatric Surgery
- Being tested
- Weight loss
- Keywords
- weight loss, bariatric surgery
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossBehavioural
All participants will have self selected for bariatric surgery and their weight loss and mitochondrial function will be measured in this study.
| Study group | Role | What they receive |
|---|---|---|
| study cohort group | The study cohort will be made up of individuals that have self selected for bariatric surgery. Receives: Behavioral: Weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The degree of weight loss after bariatric surgery
Measured: 4 months
Mitochondrial function
Degree of change in mitochondrial function as a result of weight loss
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start28 Jul 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Towson University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Nicolas D. Knuth, Towson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023133
- Sponsor's protocol ID
- 2340
- Acronym
- WLMF
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Weight Loss on Mitochondrial Function
- ClinicalTrials.gov ID
- NCT07023133
- Acronym / sponsor ID
- WLMF / 2340
- Conditions
- Weight Loss, Bariatric Surgery
- Keywords
- weight loss, bariatric surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Towson UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 28 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The procedures for this study involve two visit, one before bariatric surgery and one approximately 4 months after surgery, to our laboratory. The specific tests performed are listed below and are the same for each visit (each visit will take about 2 hours). Participants will be asked to arrive dressed in loose-fitting shorts that allow for assessments to be done on the lower leg.
Upon receipt of a signed consent form, a Demographics and Health History survey will be emailed to participants. Participants will be asked to complete the questionnaire in advance of their first in-person visit and will not be repeated at the second visit. The questionnaire will take ~10 minutes to complete and will be used to document any health conditions and medications.
Upon arrival for their in-person visit, we will measure the participant's seated blood pressure and heart rate as well as height and weight to calculate their body mass index (BMI). The following tests will then be performed:
- Body Composition measurement: A DEXA scan will be performed while the participant lays on their back. A separate risk acknowledgment form for the DXA scan will be provided. Female participants of childbearing age who believe they may be pregnant or are not sure, will be offered a free pregnancy test prior to the DEXA scan.
- Blood pressure (SphygmoCor) measurement: An automated pressure cuff will be placed on the participant's upper arm and inflated.
- Resting whole-body metabolism. This assessment measures the amount of energy the body needs at rest (i.e., resting metabolic rate) to maintain normal bodily function and will take approximately 20 minutes. Participants will be asked to lie down and rest quietly while their expired breath, collected via an open hood worn over the head, will be analyzed for oxygen and carbon dioxide content to assess their resting metabolic rate.
- Resting muscle metabolism: Muscle metabolism will be measured using near-infrared spectroscopy (NIRS), which is the typical use of the NIRS device. Specifically, a small mark will be placed on the center of the tibialis anterior (TA) muscle on the front of the dominant lower leg. An ultrasound machine will be used over the marked site on their muscle to capture an image and calculate the thickness of the TA muscle as well as the fat and skin layer over the muscle. Next, a small NIRS probe will be placed over the mark and secured into place with flexible wrap to minimize movement. There is no known risk associated with the NIRS device beyond potential irritation of the skin akin to the placement of any plastic device on the skin. NIRS measurements will be collected continuously through the duration of the test using blue-tooth. Small adhesive electrical stimulation pads will be placed on the TA muscle above and below the probe. A pneumatic blood pressure cuff will be placed around the thigh (upper leg) of their dominant leg just above the knee. The testing protocol will begin with resting measures that include 3 x 30s occlusions of the leg in which the blood pressure cuff will be inflated between 250-300mmHg. This will be followed by 30s stimulation of the muscle to mimic "exercise" to the TA muscle using electrical stimulation and then a series of short (6 x 5s) occlusions of the leg in which the blood pressure cuff will be again inflated between 250-300mmHg. The intensity of electrical stimulation is moderate and produces a tingling sensation and twitching of the muscle but is not painful. It provides a standardized muscle movement that mimics tapping of one's foot. This test will be repeated 4 times. When the repetitions are complete, the test will end with 5-minutes of blood pressure cuff occlusion and 3 minutes of data collection after the cuff is released.
- Walking metabolism measurement: Participant's customary walking speed and metabolic cost (i.e. rate of oxygen consumption) will be measured at the level of the whole-body and at the level of the muscle during a 5-minute walking test performed over a 20-meter course. Distance traveled during the 5 minutes will be used to calculate their walking speed. Whole-body metabolic cost will be calculated from the measurement of oxygen consumption and carbon dioxide production rates while walking using a COSMED indirect calorimeter device. Specifically, participants will walk while wearing a facemask (for collection of expired breath) connected to the COSMED device harnessed to their back. The COSMED and harness weigh less than 3 pounds. Muscle oxygen consumption rate (i.e., metabolic cost) while walking will be measured using the NIRS device previously placed on the TA muscle. A pneumatic blood pressure cuff will be placed around the thigh (upper leg) of their dominant leg just above the knee and inflated between 250-300 mmHg for 10 seconds at the end of the walking to allow for measurement of muscle oxygen consumption rate during the occlusion. Participants will also wear a polar hear rate monitor around their chest for measurement of heart rate while walking; heart rate will be recorded by the COSMED device via Bluetooth. These measures are painless and non-invasive. Given that participants will walk at their normal, customary gait speed, no screening for any medical conditions will be used for exclusion beyond those listed above. There is no risk beyond that risk associated with normal ambulation given the self-selected walking speed.
- Physical activity level. Objective daily physical activity data will be collected using a wrist-worn accelerometer. At the end of their visit, participants will be fitted with this watch-like device that is worn at the wrist, wear it for seven consecutive days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study cohort group | – | Behavioral: Weight lossThe study cohort will be made up of individuals that have self selected for bariatric surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with obesity that have self elected for bariatric surgery
Key inclusion criteria (1 listed)
- obesity (BMI>30 kg/m2); self elected for bariatric surgery
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight lossAll participants will have self selected for bariatric surgery and their weight loss and mitochondrial function will be measured in this study. | Behavioural | study cohort group |
Primary outcome
Weight loss
Time frame: 4 months
The degree of weight loss after bariatric surgery
Mitochondrial function
Time frame: 4 months
Degree of change in mitochondrial function as a result of weight loss
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss and Bariatric Surgery, run by Towson University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas D Knuth, Doctor of Philosophy (410-704-6247, nknuth@towson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.