ObesityNCT01595945
Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate
A study testing Gastric bypass and Caloric restriction in people with Obesity, run by KiloCoach e.U. at 2 sites in Austria.
Trial summary
Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is still unclear. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Gastric bypass and Caloric restriction
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesAustria
- Study dates
- Apr 2012to Feb 2015
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥30 kg/m2
Who cannot join
- Marked weight reduction in the last 2 years (>5% of initial body weight)
- Recent extreme fasting (during the last month)
- Manifest eating disorders (assignment to a specialist for eating disorders)
- Severe psychiatric disorders requiring treatment
- Pregnancy, lactation
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Hospital Barmherzige Schwestern Vienna
Vienna, 1060
KiloCoach e.U.
Vienna, 1060
About this study
Official title: Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects
Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is still unclear. Lower resting metabolic rates were also reported after gastric banding bariatric surgery but have not yet been investigated in subjects after gastric bypass. The purpose of this study is to investigate the consequences on resting metabolic rate in subjects with obesity after moderate caloric restriction or gastric bypass.
- Conditions
- Obesity
- Being tested
- Gastric bypass, Caloric restriction
- Keywords
- Caloric restriction, Obesity, Gastric bypass, Resting metabolic rate
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Subjects with a planned gastric bypass surgery are followed-up for resting metabolic rate.
Caloric restrictionBehavioural
Subjects receive caloric restriction as calculated by an online weight management program and are followed-up for resting metabolic rate.
| Study group | Role | What they receive |
|---|---|---|
| Gastric bypass | Other | Subjects with planned gastric bypass surgery are followed-up in regard of resting metabolic rate. Receives: Procedure: Gastric bypass |
| Caloric restriction | Other | Caloric restriction calculated by an online weight management program (based on subject's starting weight, start BMI, age, target weight and time span). Subjects are followed-up in regard to resting metabolic rate. Receives: Behavioral: Caloric restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting metabolic rate
Measured: 24 weeks
Secondary outcomes (4)
Body composition (muscle mass, fat mass)
Measured: 24 weeks
Body Mass Index
Measured: 24 weeks
Caloric restriction
Measured: 24 weeks
Weight loss
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startApr 2012
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KiloCoach e.U.
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Barmherzige Schwestern Vienna
- Responsible party
- Sponsor
- Investigators
- Rosa Aspalter, MD., Study director, KiloCoach e.U.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595945
- Sponsor's protocol ID
- KCKBHS-01
- Status last verified
- Feb 2015
- First submitted
- 9 May 2012
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Caloric Restriction and Gastric Bypass on Resting Metabolic Rate in Obese Subjects
- ClinicalTrials.gov ID
- NCT01595945
- Acronym / sponsor ID
- KCKBHS-01
- Conditions
- Obesity
- Keywords
- Caloric restriction, Obesity, Gastric bypass, Resting metabolic rate
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- KiloCoach e.U.University, hospital or other
- Collaborators
- Hospital Barmherzige Schwestern Vienna
- Study start
- Apr 2012
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 10 May 2012 (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.
Studies in overweight and obese subjects show a decline in resting metabolic rate (RMR) even after moderate caloric restriction. Yet the onset and course of such a metabolic adaption is still unclear. Lower resting metabolic rates were also reported after gastric banding bariatric surgery but have not yet been investigated in subjects after gastric bypass. The purpose of this study is to investigate the consequences on resting metabolic rate in subjects with obesity after moderate caloric restriction or gastric bypass.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric bypass | Other | Procedure: Gastric bypassSubjects with planned gastric bypass surgery are followed-up in regard of resting metabolic rate. |
| Caloric restriction | Other | Behavioral: Caloric restrictionCaloric restriction calculated by an online weight management program (based on subject's starting weight, start BMI, age, target weight and time span). Subjects are followed-up in regard to resting metabolic rate. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI ≥30 kg/m2
Key exclusion criteria (5 listed)
- Marked weight reduction in the last 2 years (>5% of initial body weight)
- Recent extreme fasting (during the last month)
- Manifest eating disorders (assignment to a specialist for eating disorders)
- Severe psychiatric disorders requiring treatment
- Pregnancy, lactation
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 |
|---|---|---|
| Gastric bypassSubjects with a planned gastric bypass surgery are followed-up for resting metabolic rate. | Procedure or surgery | Gastric bypass |
| Caloric restrictionSubjects receive caloric restriction as calculated by an online weight management program and are followed-up for resting metabolic rate. | Behavioural | Caloric restriction |
Primary outcome
Resting metabolic rate
Time frame: 24 weeks
4 secondary outcomes
Body composition (muscle mass, fat mass)
Time frame: 24 weeks
Body Mass Index
Time frame: 24 weeks
Caloric restriction
Time frame: 24 weeks
Weight loss
Time frame: 24 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
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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.
Rosa Aspalter, MD. study director
KiloCoach e.U.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric bypass and Caloric restriction in people with Obesity, run by KiloCoach e.U. at 2 sites in Austria.
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 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: stopped early, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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 stopped early. Results are not available in the source record.
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?
Resting metabolic rate (time frame: 24 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 5 Feb 2015.