Morbid ObesityEnergyNCT00671957
Energy Expenditure and Gastric Bypass Surgery Study
An observational study of Morbid Obesity, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The aim of this study is to assess whether the energy you burn daily increases after you have bariatric surgery. Until now, there hasn't been an effective way of measuring all activity on a daily basis. Physical Activity Monitoring System (PAMS) has been created just for this purpose. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Morbid Obesity
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jun 2019
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbidly obese patients undergoing Bariatric surgery.
Who may be able to join
- No acute illnesses
- Weight less than 227 kg (limit of Bod Pod and Treadmill)
- Able to walk at 2.4 mph for 15 minutes (needed for the energy expenditure testing)
- No tobacco use
- Ability to stop alcohol consumption during test phases
- For female subjects; no plans for pregnancy in 24 months and menstrual cycles of 21-35 days
Show all 10Show fewer
- No history of eating disorder
- No history of current substance abuse
- No history of chest pain or shortness of breath at rest or on exertion.
- Negative pregnancy in women.
Who cannot join
- Informed consent not obtained
- Prior bariatric surgery
- Unlikely to comply with follow-up protocol (e.g., travel time from home too long to make visits feasible, unwilling to return for follow-up visits)
- Unable to communicate with local study staff
- Lactating women
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The aim of this study is to assess whether the energy you burn daily increases after you have bariatric surgery. Until now, there hasn't been an effective way of measuring all activity on a daily basis. Physical Activity Monitoring System (PAMS) has been created just for this purpose. PAMS is a garment that can be worn under your clothes, that records body position and movement through space. We will use the PAMS along with special water to measure your total daily energy expenditure right before surgery, and again 6 months and 24 months after surgery.
Study subjects will be initially recruited from OHSU IRB-Approved advertisements. Interested study subjects will be screened through an informal telephone interview. If there are no health conditions that exclude participation, subjects will be asked to give IRB-approved consent.
Subjects will be consenting to undergo three 18 day phases. Each phase will consist of 15 daily visits to the Clinical \& Translational Research Center (CTRC), and 3 full day and nights in the CTRC.
Read the detailed description
The aim of this study is to assess whether the energy you burn daily increases after you have bariatric surgery. Until now, there hasn't been an effective way of measuring all activity on a daily basis. Physical Activity Monitoring System (PAMS) has been created just for this purpose. PAMS is a garment that can be worn under your clothes, that records body position and movement through space. We will use the PAMS along with special water to measure your total daily energy expenditure right before surgery, and again 6 months and 24 months after surgery.
Study subjects will be initially recruited from OHSU IRB-Approved advertisements. Interested study subjects will be screened through an informal telephone interview. If there are no health conditions that exclude participation, subjects will be asked to give IRB-approved consent.
Subjects will be consenting to undergo three 18 day phases. Each phase will consist of 15 daily visits to the Clinical \& Translational Research Center (CTRC), and 3 full day and nights in the CTRC. The CTRC day visits will be 1 hour visits, where subjects will shower, replace their dirty PAMS with a clean PAMS, have their weight measured and be asked to walk on a treadmill for a total of 12 minutes with 3 minutes each at 0.0, 0.6, 1.6 and 2.4 mph. Subjects will be asked to drink special water on Day 2, and daily urine samples will be collected for 14 days. On Day 16 subjects will undergo a series of Energy Expenditure tests using a breath analyzer. Subjects will begin with lying for 30 minutes, then sitting for 20 minutes, standing for 20 minutes, and a transitional period of standing and sitting for 20 minutes. Subjects will then be asked to walk for three 15 minute intervals at 0.8, 1.6, and 2.4 mph. Day 17 will be a repeat of Day 16 but will be followed by Dual Energy X-Ray Absorptiometry (DEXA) or BodPod (for individuals over 350 lbs) which is device which uses the movement of air to measure your muscle and fat volumes. Day 18 subjects will begin with lying for 30 minutes,then be given a breakfast to eat. Their breathing test will then continue every 15 of 30 minutes after eating breakfast to assess how much energy their body burns during digestion, for 450 minutes (7.5 hours).
PAMS allows physical activity to be measured precisely during daily activities. By attaching sensors (inclinometers) to the torso and thigh, body posture can be defined:
Lying: torso and thigh sensors indicate horizontal, Standing: torso and thigh sensors indicate vertical, Sitting: torso sensor = vertical, thigh sensor = horizontal. Duplicate sensor sets are used in all subjects to gather duplicate data every ½ second for 14 days. The physical activity data are combined with the breath measurement data to allow us to measure all forms of activity. The following are key features; specialized sensors (accelerometers) are completely integrated with the inclinometers so that data on body position and movement are continuously gathered; the sensors are attached to the subject using a harnesses that allows a full range of daytime and nighttime physical activities as well as bathroom use.
Data analysis is simple requiring a standard PC that runs Excel and written macros programs. Once this data is downloaded, it will be sent to Mayo Rochester where it will be analyzed for the following:
- Time-spent lying, sitting, standing and walking,
- Average accelerometer output for non-walking activities (lying, sitting and standing).
- Average accelerometer output for walking and,
- Number of transitions made between postures (e.g. 'sitting-to-standing'). Breathing feedback will be used to calculate, in duplicate measurements of the Energy Expenditure (EE) of sitting, standing, transitions and walking at 0.8, 1.6 and 2.4 mph.
Posture and activity EE data collection. For the physical activity monitoring period (Days 2-15), the EE for sitting, standing and transitions will be calculated by multiplying the time engaged in each activity (or number of transitions) by the EE for that activity.
Non-Exercise Activity EE = EE sitting + EE standing + EE transitions + EE walking.
The special water will be measured in the urine collected daily. The daily urine samples will be shipped to and analyzed by University of Wisconsin's special instrument in Dr. Schoeller's lab. This special water has the ability to tell us your total energy expenditure over the whole day. The special water has a marker or label attached to the water molecule. The special instrument reads how many water molecules possess this special label. Body water excreted through urine can tell us a person's total daily energy expenditure.
- Conditions
- Morbid Obesity
- Keywords
- Obesity, Bariatric, Surgery, Activity
- Medical subject headings
- Obesity, Morbid, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing gastric bypass | Patients undergoing gastric bypass surgery and who are participants in Longitudinal Assessment of Bariatric Surgery (LABS-2). Inclusion Criteria: * No acute illnesses * Weight less than 227 kg (limit of Bod Pod and Treadmill) * Able to walk at 2.4 mph for 15 minutes (needed for the energy expenditure testing) * No tobacco use * Ability to stop alcohol consumption during test phases * For female subjects; no plans for pregnancy in 24 months and menstrual cycles of 21-35 days * No history of eating disorder * No history of current substance abuse * No history of chest pain or shortness of breath at rest or on exertion. * Negative pregnancy in women. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare physical activity and activity thermogenesis in patients undergoing gastric bypass bariatric surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
To compare physical activity and activity thermogenesis in patients undergoing gastric bypass bariatric surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
Measured: 24 months
Secondary outcomes (2)
To evaluate whether changes in weight correlate with changes in activity thermogenesis in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
To evaluate whether changes in weight correlate with changes in activity thermogenesis in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
Measured: 24 months
To evaluate the changes in basal metabolic rate (BMR) and thermic effect of food (TEF) in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
To evaluate the changes in basal metabolic rate (BMR) and thermic effect of food (TEF) in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2008 (estimated)
- Study startFeb 2006
- Primary completionJul 2007
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Bruce Wolfe, Oregon Health and Science University
- Investigators
- Bruce M Wolfe, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671957
- Sponsor's protocol ID
- IRB00002212
- Acronym
- Energy
- Status last verified
- Jun 2019
- First submitted
- 2 May 2008
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Expenditure and Gastric Bypass Surgery Study
- ClinicalTrials.gov ID
- NCT00671957
- Acronym / sponsor ID
- Energy / IRB00002212
- Conditions
- Morbid Obesity
- Keywords
- Obesity, Bariatric, Surgery, Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- Feb 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 6 May 2008 (estimated)
- 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 aim of this study is to assess whether the energy you burn daily increases after you have bariatric surgery. Until now, there hasn't been an effective way of measuring all activity on a daily basis. Physical Activity Monitoring System (PAMS) has been created just for this purpose. PAMS is a garment that can be worn under your clothes, that records body position and movement through space. We will use the PAMS along with special water to measure your total daily energy expenditure right before surgery, and again 6 months and 24 months after surgery.
Study subjects will be initially recruited from OHSU IRB-Approved advertisements. Interested study subjects will be screened through an informal telephone interview. If there are no health conditions that exclude participation, subjects will be asked to give IRB-approved consent.
Subjects will be consenting to undergo three 18 day phases. Each phase will consist of 15 daily visits to the Clinical \& Translational Research Center (CTRC), and 3 full day and nights in the CTRC.
Detailed description
The aim of this study is to assess whether the energy you burn daily increases after you have bariatric surgery. Until now, there hasn't been an effective way of measuring all activity on a daily basis. Physical Activity Monitoring System (PAMS) has been created just for this purpose. PAMS is a garment that can be worn under your clothes, that records body position and movement through space. We will use the PAMS along with special water to measure your total daily energy expenditure right before surgery, and again 6 months and 24 months after surgery.
Study subjects will be initially recruited from OHSU IRB-Approved advertisements. Interested study subjects will be screened through an informal telephone interview. If there are no health conditions that exclude participation, subjects will be asked to give IRB-approved consent.
Subjects will be consenting to undergo three 18 day phases. Each phase will consist of 15 daily visits to the Clinical \& Translational Research Center (CTRC), and 3 full day and nights in the CTRC. The CTRC day visits will be 1 hour visits, where subjects will shower, replace their dirty PAMS with a clean PAMS, have their weight measured and be asked to walk on a treadmill for a total of 12 minutes with 3 minutes each at 0.0, 0.6, 1.6 and 2.4 mph. Subjects will be asked to drink special water on Day 2, and daily urine samples will be collected for 14 days. On Day 16 subjects will undergo a series of Energy Expenditure tests using a breath analyzer. Subjects will begin with lying for 30 minutes, then sitting for 20 minutes, standing for 20 minutes, and a transitional period of standing and sitting for 20 minutes. Subjects will then be asked to walk for three 15 minute intervals at 0.8, 1.6, and 2.4 mph. Day 17 will be a repeat of Day 16 but will be followed by Dual Energy X-Ray Absorptiometry (DEXA) or BodPod (for individuals over 350 lbs) which is device which uses the movement of air to measure your muscle and fat volumes. Day 18 subjects will begin with lying for 30 minutes,then be given a breakfast to eat. Their breathing test will then continue every 15 of 30 minutes after eating breakfast to assess how much energy their body burns during digestion, for 450 minutes (7.5 hours).
PAMS allows physical activity to be measured precisely during daily activities. By attaching sensors (inclinometers) to the torso and thigh, body posture can be defined:
Lying: torso and thigh sensors indicate horizontal, Standing: torso and thigh sensors indicate vertical, Sitting: torso sensor = vertical, thigh sensor = horizontal. Duplicate sensor sets are used in all subjects to gather duplicate data every ½ second for 14 days. The physical activity data are combined with the breath measurement data to allow us to measure all forms of activity. The following are key features; specialized sensors (accelerometers) are completely integrated with the inclinometers so that data on body position and movement are continuously gathered; the sensors are attached to the subject using a harnesses that allows a full range of daytime and nighttime physical activities as well as bathroom use.
Data analysis is simple requiring a standard PC that runs Excel and written macros programs. Once this data is downloaded, it will be sent to Mayo Rochester where it will be analyzed for the following:
- Time-spent lying, sitting, standing and walking,
- Average accelerometer output for non-walking activities (lying, sitting and standing).
- Average accelerometer output for walking and,
- Number of transitions made between postures (e.g. 'sitting-to-standing'). Breathing feedback will be used to calculate, in duplicate measurements of the Energy Expenditure (EE) of sitting, standing, transitions and walking at 0.8, 1.6 and 2.4 mph.
Posture and activity EE data collection. For the physical activity monitoring period (Days 2-15), the EE for sitting, standing and transitions will be calculated by multiplying the time engaged in each activity (or number of transitions) by the EE for that activity.
Non-Exercise Activity EE = EE sitting + EE standing + EE transitions + EE walking.
The special water will be measured in the urine collected daily. The daily urine samples will be shipped to and analyzed by University of Wisconsin's special instrument in Dr. Schoeller's lab. This special water has the ability to tell us your total energy expenditure over the whole day. The special water has a marker or label attached to the water molecule. The special instrument reads how many water molecules possess this special label. Body water excreted through urine can tell us a person's total daily energy expenditure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing gastric bypass | – | –Patients undergoing gastric bypass surgery and who are participants in Longitudinal Assessment of Bariatric Surgery (LABS-2). Inclusion Criteria: * No acute illnesses * Weight less than 227 kg (limit of Bod Pod and Treadmill) * Able to walk at 2.4 mph for 15 minutes (needed for the energy expenditure testing) * No tobacco use * Ability to stop alcohol consumption during test phases * For female subjects; no plans for pregnancy in 24 months and menstrual cycles of 21-35 days * No history of eating disorder * No history of current substance abuse * No history of chest pain or shortness of breath at rest or on exertion. * Negative pregnancy in women. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbidly obese patients undergoing Bariatric surgery.
Key inclusion criteria (10 listed)
- No acute illnesses
- Weight less than 227 kg (limit of Bod Pod and Treadmill)
- Able to walk at 2.4 mph for 15 minutes (needed for the energy expenditure testing)
- No tobacco use
- Ability to stop alcohol consumption during test phases
Key exclusion criteria (5 listed)
- Informed consent not obtained
- Prior bariatric surgery
- Unlikely to comply with follow-up protocol (e.g., travel time from home too long to make visits feasible, unwilling to return for follow-up visits)
- Unable to communicate with local study staff
- Lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare physical activity and activity thermogenesis in patients undergoing gastric bypass bariatric surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
Time frame: 24 months
To compare physical activity and activity thermogenesis in patients undergoing gastric bypass bariatric surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
2 secondary outcomes
To evaluate whether changes in weight correlate with changes in activity thermogenesis in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
Time frame: 24 months
To evaluate the changes in basal metabolic rate (BMR) and thermic effect of food (TEF) in patients undergoing gastric bypass surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
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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.
Bruce M Wolfe, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Oregon Health and Science University 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 21 Jun 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare physical activity and activity thermogenesis in patients undergoing gastric bypass bariatric surgery at baseline (pre-operatively) and 6 and 24 months after gastric bypass surgery. (time frame: 24 months). 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 21 Jun 2019.