Bariatric Surgery CandidateBaSENCT06274606
Exercise Training Study Before Bariatric Surgery
A study testing Exercise Group in people with Bariatric Surgery Candidate, run by University of Virginia at 1 site in United States.
Trial summary
The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Bariatric Surgery Candidate
- What is being tested?
- Exercise Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI: 35 - 45 kg/m2. For adults of Asian race or descent, the BMI cutoff is between 25-27.5 kg/m2 to be considered for surgery and thus will be considered for inclusion in this study.
- Considered sedentary based on self-reported inactivity of < 2-3 x/week of MVPA within previous 3 months before enrollment.
- Able to walk without use of assistive device, such as cane or walker for ≥ 10 minutes.
- Surgery approved within 6-9 months of initial visit.
- Signed approval from study physician (Dr. Catherine W. Varney; Medical PI of study) that participant is capable to participate.
- Willingness to accept group randomization assignment.
Who cannot join
- Any serious medical conditions, such as cancer; history cardiovascular disease of stroke, heart attack, or heart failure; type 1 diabetes mellitus; severe psychiatric illness (such as severe depression); kidney disease.
- Autoimmune diseases such as lupus, multiple sclerosis, Graves' disease, or rheumatoid arthritis.
- HIV or tuberculosis.
- Currently taking medications that lead to significant weight loss (e.g., semaglutide; tirzepatide, etc).
- Resting SBP > 150 mmHg, DBP > 100 mmHg.
- Current pregnancy or plans to become pregnant during intervention.
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- Plans to be away from the Charlottesville, VA area for > 1 week during intervention or plans of relocating during the intervention.
- Any medical or health condition (e.g., musculoskeletal, orthopedic, or neurological conditions) that is contraindicated for safe exercise testing and training.
- Previous weight-loss surgeries or revisions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22902
About this study
The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).
Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.
Read more
Researchers will compare the effects of walking before bariatric surgery on:
- Insulin sensitivity (diabetes risk factor)
- Health of blood vessels
- Rate of complications after surgery
- Weight
- Body Fat
- Fitness level
Read the detailed description
The purpose of the present study is to evaluate the impact of 8 weeks of supervised aerobic exercise prior to bariatric surgery on insulin sensitivity using the hyperinsulinemic-euglycemic clamp. Participants will be recruited from the area surrounding the UVA hospital, while the primary outcome will be insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp procedure and secondary outcomes include the effects of the exercise intervention on surgical outcomes and cardiometabolic and arterial health in bariatric patients.
Objectives:
Primary Objective: To investigate the effects of exercise + standard care and standard care only in obese individuals prior to bariatric surgery on insulin sensitivity after bariatric surgery.
Secondary Objectives: To examine the effects of exercise + standard care and standard care only in obese individuals prior to bariatric surgery on surgical outcomes, such as length of stay post-surgery, and other clinically relevant outcomes, such as cardiometabolic and arterial health, in adults following bariatric surgery.
Hypotheses:
Primary Hypothesis: An 8-week exercise intervention before bariatric surgery will improve insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp following bariatric surgery.
Secondary Hypothesis: An 8-week exercise intervention will improve clinically relevant post-surgical outcomes, such as surgical outcomes, quality of life, arterial health, and other cardiometabolic factors following bariatric surgery.
- Conditions
- Bariatric Surgery Candidate
- Being tested
- Exercise Group
- Keywords
- Bariatric surgery, Obesity, Insulin sensitivity, Exercise intervention
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise GroupOther
Previously sedentary adults awaiting bariatric surgery will be randomized to either an Exercise group (EX-group) or Standard care only group (SC-group) for 8 weeks. Outcome visits will occur before the exercise intervention, after the exercise intervention, and after surgery
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group (EX-group) | Experimental | The EX-group will complete 8 weeks of supervised aerobic exercise training. The EX-group will also continue normal care with bariatric doctors and nurses along with the exercise intervention. Receives: Other: Exercise Group |
| Standard Care Only Group (SC-group) | No intervention | The SC-group will only complete the orientation visit and testing visits. The participants that are randomized to this group will continue normal care with bariatric doctors and nurses. They will participate in study assessment visits only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity measured via the hyperinsulinemic-euglycemic clamp
Measured: Change from baseline to after surgery (12 weeks)
Secondary outcomes (19)
Surgical outcomes - readmission within 30 days of surgery
Variables recorded after surgery such as readmission within 30 days of surgery
Measured: within 30 days
Surgical outcomes - IV treatment as an outpatient
Variables recorded after surgery such as IV treatment as an outpatient
Measured: Change from baseline to after surgery (12 weeks)
Surgical outcomes - emergency department visits
Variables recorded after surgery such as emergency department visits
Measured: Change from baseline to after surgery (12 weeks)
Surgical outcomes - time of surgery
Variables recorded after surgery such as time of surgery (min).
Measured: Intraoperative
Surgical outcomes - length of stay after surgery completion
Variables recorded after surgery such as length of stay after surgery
Measured: Change from baseline to after surgery (12 weeks)
Flow-mediated dilation (FMD)
Endothelial function measured via flow mediated dilation (FMD) (%) - indication of shear-stress-mediated dilation following occlusion
Measured: Change from baseline to after surgery (12 weeks)
Pulse-wave analysis (PWA)
Pulse-wave analysis (PWA) as measured with a SphygmoCor Xcel to measure brachial systolic and diastolic pressures and to capture a brachial waveform.
Measured: Change from baseline to after surgery (12 weeks)
Pulse-wave velocity (PWV)
Pulse-wave velocity (PWV) as measured with a SphygmoCor Xcel to measure the blood pressure waveforms at the carotid and femoral artery sites.
Measured: Change from baseline to after surgery (12 weeks)
Body fat
Dual-energy x-ray absorptiometry (DEXA) will be used to access body fat (g)
Measured: Change from baseline to after surgery (12 weeks)
Lean body mass
Dual-energy x-ray absorptiometry (DEXA) will be used to access lean body mass
Measured: Change from baseline to after surgery (12 weeks)
Bone mineral density
Dual-energy x-ray absorptiometry (DEXA) will be used to access bone mineral density (g)
Measured: Change from baseline to after surgery (12 weeks)
Visceral adiposity
Dual-energy x-ray absorptiometry (DEXA) will be used to access visceral adiposity measures (g)
Measured: Change from baseline to after surgery (12 weeks)
Weight
Body weight measured on a level beam scale; minimum value 0 kg-500kg; higher scores tend to suggest worsened outcomes
Measured: Change from baseline to after surgery (12 weeks)
Blood Lipids
Cholesterol values, including HDL-C, LDL-C, and VLDL-C (mg/dL) from intravenous line
Measured: Change from baseline to after surgery (12 weeks)
Plasma glucose
Plasma glucose (mg/dL) from intravenous line
Measured: Change from baseline to after surgery (12 weeks)
Plasma insulin
Plasma insulin (uIU/dL) from intravenous line
Measured: Change from baseline to after surgery (12 weeks)
Hemoglobin A1c
Hemoglobin A1C (%) - an average of blood glucose levels in the previous 3 months
Measured: up to 12 weeks
Cardiorespiratory fitness
Vo2 max measured via a maximal exercise test on a treadmill
Measured: Change from baseline to after surgery (12 weeks)
Quality of life (SF-36)
Quality of life will be assessed via the SF-36 and the variables included in the questionnaire are physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH)
Measured: Change from baseline to after surgery (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Why it stopped: Project during development was discontinued before the enrollment of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery CandidateStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In accordance with a parallel study design, 30 pre-bariatric-surgery patients will be randomized in a 1:1 ratio to either undergo 8-weeks of pre-operative standard of care or 8-weeks of pre-operative standard of care plus moderate exercise prior to undergoing bariatric-surgery. Randomization scheme: The randomization will be generated utilizing a permuted block randomization scheme in which 5 blocks of 6 treatment assignments (3 per treatment) will be generated via a computer algorithm. The 6 treatment assignments of each block will be listed in random sequential order and the treatment assignments will be assigned according to the random sequential order. The randomization will be generated by our biostatistician.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damon Swift, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274606
- Sponsor's protocol ID
- HSR230106
- Acronym
- BaSE
- Status last verified
- Jun 2024
- First submitted
- 18 Jan 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training Study Before Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06274606
- Acronym / sponsor ID
- BaSE / HSR230106
- Conditions
- Bariatric Surgery Candidate
- Keywords
- Bariatric surgery, Obesity, Insulin sensitivity, Exercise intervention
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Project during development was discontinued before the enrollment of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 23 Feb 2024 (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.
The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).
Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.
Researchers will compare the effects of walking before bariatric surgery on:
- Insulin sensitivity (diabetes risk factor)
- Health of blood vessels
- Rate of complications after surgery
- Weight
- Body Fat
- Fitness level
Detailed description
The purpose of the present study is to evaluate the impact of 8 weeks of supervised aerobic exercise prior to bariatric surgery on insulin sensitivity using the hyperinsulinemic-euglycemic clamp. Participants will be recruited from the area surrounding the UVA hospital, while the primary outcome will be insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp procedure and secondary outcomes include the effects of the exercise intervention on surgical outcomes and cardiometabolic and arterial health in bariatric patients.
Objectives:
Primary Objective: To investigate the effects of exercise + standard care and standard care only in obese individuals prior to bariatric surgery on insulin sensitivity after bariatric surgery.
Secondary Objectives: To examine the effects of exercise + standard care and standard care only in obese individuals prior to bariatric surgery on surgical outcomes, such as length of stay post-surgery, and other clinically relevant outcomes, such as cardiometabolic and arterial health, in adults following bariatric surgery.
Hypotheses:
Primary Hypothesis: An 8-week exercise intervention before bariatric surgery will improve insulin sensitivity as measured by the hyperinsulinemic-euglycemic clamp following bariatric surgery.
Secondary Hypothesis: An 8-week exercise intervention will improve clinically relevant post-surgical outcomes, such as surgical outcomes, quality of life, arterial health, and other cardiometabolic factors following bariatric surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In accordance with a parallel study design, 30 pre-bariatric-surgery patients will be randomized in a 1:1 ratio to either undergo 8-weeks of pre-operative standard of care or 8-weeks of pre-operative standard of care plus moderate exercise prior to undergoing bariatric-surgery. Randomization scheme: The randomization will be generated utilizing a permuted block randomization scheme in which 5 blocks of 6 treatment assignments (3 per treatment) will be generated via a computer algorithm. The 6 treatment assignments of each block will be listed in random sequential order and the treatment assignments will be assigned according to the random sequential order. The randomization will be generated by our biostatistician.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group (EX-group) | Experimental | Other: Exercise GroupThe EX-group will complete 8 weeks of supervised aerobic exercise training. The EX-group will also continue normal care with bariatric doctors and nurses along with the exercise intervention. |
| Standard Care Only Group (SC-group) | No intervention | –The SC-group will only complete the orientation visit and testing visits. The participants that are randomized to this group will continue normal care with bariatric doctors and nurses. They will participate in study assessment visits only. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI: 35 - 45 kg/m2. For adults of Asian race or descent, the BMI cutoff is between 25-27.5 kg/m2 to be considered for surgery and thus will be considered for inclusion in this study.
- Considered sedentary based on self-reported inactivity of < 2-3 x/week of MVPA within previous 3 months before enrollment.
- Able to walk without use of assistive device, such as cane or walker for ≥ 10 minutes.
- Surgery approved within 6-9 months of initial visit.
- Signed approval from study physician (Dr. Catherine W. Varney; Medical PI of study) that participant is capable to participate.
Key exclusion criteria (9 listed)
- Any serious medical conditions, such as cancer; history cardiovascular disease of stroke, heart attack, or heart failure; type 1 diabetes mellitus; severe psychiatric illness (such as severe depression); kidney disease.
- Autoimmune diseases such as lupus, multiple sclerosis, Graves' disease, or rheumatoid arthritis.
- HIV or tuberculosis.
- Currently taking medications that lead to significant weight loss (e.g., semaglutide; tirzepatide, etc).
- Resting SBP > 150 mmHg, DBP > 100 mmHg.
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 |
|---|---|---|
| Exercise GroupPreviously sedentary adults awaiting bariatric surgery will be randomized to either an Exercise group (EX-group) or Standard care only group (SC-group) for 8 weeks. Outcome visits will occur before the exercise intervention, after the exercise intervention, and after surgery | Other | Exercise Group (EX-group) |
Primary outcome
Insulin sensitivity
Time frame: Change from baseline to after surgery (12 weeks)
Insulin sensitivity measured via the hyperinsulinemic-euglycemic clamp
19 secondary outcomes
Surgical outcomes - readmission within 30 days of surgery
Time frame: within 30 days
Surgical outcomes - IV treatment as an outpatient
Time frame: Change from baseline to after surgery (12 weeks)
Surgical outcomes - emergency department visits
Time frame: Change from baseline to after surgery (12 weeks)
Surgical outcomes - time of surgery
Time frame: Intraoperative
Surgical outcomes - length of stay after surgery completion
Time frame: Change from baseline to after surgery (12 weeks)
Flow-mediated dilation (FMD)
Time frame: Change from baseline to after surgery (12 weeks)
Pulse-wave analysis (PWA)
Time frame: Change from baseline to after surgery (12 weeks)
Pulse-wave velocity (PWV)
Time frame: Change from baseline to after surgery (12 weeks)
Body fat
Time frame: Change from baseline to after surgery (12 weeks)
Lean body mass
Time frame: Change from baseline to after surgery (12 weeks)
Bone mineral density
Time frame: Change from baseline to after surgery (12 weeks)
Visceral adiposity
Time frame: Change from baseline to after surgery (12 weeks)
Weight
Time frame: Change from baseline to after surgery (12 weeks)
Blood Lipids
Time frame: Change from baseline to after surgery (12 weeks)
Plasma glucose
Time frame: Change from baseline to after surgery (12 weeks)
Plasma insulin
Time frame: Change from baseline to after surgery (12 weeks)
Hemoglobin A1c
Time frame: up to 12 weeks
Cardiorespiratory fitness
Time frame: Change from baseline to after surgery (12 weeks)
Quality of life (SF-36)
Time frame: Change from baseline to after surgery (12 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Group in people with Bariatric Surgery Candidate, run by University of Virginia at 1 site in United States.
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 6 inclusion and 9 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: withdrawn, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: Change from baseline to after surgery (12 weeks)). 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 14 Jun 2024.