ObesityBIANCT02975427
Bioimpedance Analysis for Follow-up of Dieters
An observational study of Obesity, run by Baskent University Ankara Hospital.
Trial summary
Prospective, single arm, dietary intervention study. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Diet group
- How many people
- 103 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Mar 2014
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: One hundred and eighty five participants who were admitted to hospital for weight loss therapy enrolled to the study. After initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. A total of 134 participants reported for the second visit; 51 did not. Thirty one participants who, at the second visit, reported that they failed to adhere to the diet were excluded from the analysis . Ultimately, data from 103 participants who reported that they adhered to the diet were included in the analysis.
Who may be able to join
- Participants aged 18 to 70 years without chronic disease, cancer, a pacemaker, cardiac valve replacement, malabsorption syndrome, previous history of gastrointestinal surgery, thyroid disease, pregnancy, or a history of surgery during the previous 3 months.
Who cannot join
- Participants receiving oral antidiabetic drugs, insulin, any treatment for obesity, steroids or hormonal drugs, over-the-counter drugs for weight loss, any kind of phytodrug, or any drug that could affect glucose metabolism. We also excluded patients who used any of these drugs after the initial evaluation.
- Participants who, at the second visit, reported that they failed to adhere to the diet.
About this study
Official title: Abdominal Bioelectric Impedance for Follow-up of Dieters: A Prospective Study
Prospective, single arm, dietary intervention study.
Read the detailed description
This prospective study was conducted during the period from December 2011 through June 2013 in the Department of Endocrinology and Metabolism of Başkent University.
We enrolled 185 participants who were admitted to hospital for weight loss therapy. After initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. At the end of the follow up, 103 participants attended to the research. Anthropometric, bioimpedance and laboratory measurements performed at baseline and second visit. We calculated the difference in anthropometric, bioimpedance and laboratory measurements between the first and second evaluations. Correlation analysis, multivariate linear regression analysis and receiver operating characteristic analysis performed to assess associations of laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis (BIA) measures, after diet and/or exercise therapy. The secondary aim was to determine whether abdominal BIA was better than simple anthropometric measurements and conventional BIA for assessing changes in metabolic variables.
- Conditions
- Obesity
- Being tested
- Diet group
- Keywords
- Diet, Abdominal bioelectrical impedance analysis, Anthropometry, Insulin resistance
- 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.
Diet groupOther
All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.
| Study group | Role | What they receive |
|---|---|---|
| Diet group | All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. Receives: Other: Diet group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of abdominal BIA for the follow up of dieting individual
Measured: 3 months (plus or minus 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionMar 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University Ankara Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf Bozkuş, Baskent University Ankara Hospital
- Investigators
- Yusuf Bozkuş, Dr., Principal investigator, Baskent University Ankara Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02975427
- Sponsor's protocol ID
- KA12/192
- Acronym
- BIA
- Status last verified
- Nov 2016
- First submitted
- 27 Oct 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Bioelectric Impedance for Follow-up of Dieters: A Prospective Study
- ClinicalTrials.gov ID
- NCT02975427
- Acronym / sponsor ID
- BIA / KA12/192
- Conditions
- Obesity
- Keywords
- Diet, Abdominal bioelectrical impedance analysis, Anthropometry, Insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Baskent University Ankara HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 29 Nov 2016 (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.
Prospective, single arm, dietary intervention study.
Detailed description
This prospective study was conducted during the period from December 2011 through June 2013 in the Department of Endocrinology and Metabolism of Başkent University.
We enrolled 185 participants who were admitted to hospital for weight loss therapy. After initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. At the end of the follow up, 103 participants attended to the research. Anthropometric, bioimpedance and laboratory measurements performed at baseline and second visit. We calculated the difference in anthropometric, bioimpedance and laboratory measurements between the first and second evaluations. Correlation analysis, multivariate linear regression analysis and receiver operating characteristic analysis performed to assess associations of laboratory metabolic variables with a decrease in anthropometric and bioimpedance analysis (BIA) measures, after diet and/or exercise therapy. The secondary aim was to determine whether abdominal BIA was better than simple anthropometric measurements and conventional BIA for assessing changes in metabolic variables.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diet group | – | Other: Diet groupAll participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and eighty five participants who were admitted to hospital for weight loss therapy enrolled to the study. After initial evaluation, all participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. A total of 134 participants reported for the second visit; 51 did not. Thirty one participants who, at the second visit, reported that they failed to adhere to the diet were excluded from the analysis . Ultimately, data from 103 participants who reported that they adhered to the diet were included in the analysis.
Key inclusion criteria (1 listed)
- Participants aged 18 to 70 years without chronic disease, cancer, a pacemaker, cardiac valve replacement, malabsorption syndrome, previous history of gastrointestinal surgery, thyroid disease, pregnancy, or a history of surgery during the previous 3 months.
Key exclusion criteria (2 listed)
- Participants receiving oral antidiabetic drugs, insulin, any treatment for obesity, steroids or hormonal drugs, over-the-counter drugs for weight loss, any kind of phytodrug, or any drug that could affect glucose metabolism. We also excluded patients who used any of these drugs after the initial evaluation.
- Participants who, at the second visit, reported that they failed to adhere to the diet.
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 |
|---|---|---|
| Diet groupAll participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later. | Other | Diet group |
Primary outcome
Value of abdominal BIA for the follow up of dieting individual
Time frame: 3 months (plus or minus 1 month)
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 29 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Yusuf Bozkuş, Dr. principal investigator
Baskent University Ankara Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Baskent University Ankara Hospital.
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 2 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 29 Nov 2016. 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?
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?
Value of abdominal BIA for the follow up of dieting individual (time frame: 3 months (plus or minus 1 month)). 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 29 Nov 2016.