ObesityNCT03346421
Anthropometric Parameters, Metabolic Profile and Function of the Respiratory System in Obese Patients
An observational study of Obesity and Diet Modification, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Obesity is currently considered an increasingly more severe social and health related problem. The World Health Organization qualified obesity as a chronic disease along with circulatory diseases, diabetes, cancer and respiratory diseases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Diet Modification, Physical Activity
- What is being tested?
- diet and physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2016to 21 Dec 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study will be conducted on a group of a 100 persons with obesity who fulfilled the inclusion criteria (index BMI>30 kg/m2/ and an increased adipose tissue content assessed by the electrical bioimpedance method).
Who may be able to join
- patient's age: above 18 years of age
- BMI obesity >30kg/m2
- increased content of overall adipose tissue measured by bioelectrical impendance method
- consent to take part in the study
Who cannot join
- positive electrocardiographic stress test
- staying on a vegetarian or any other alternative diet
- patients with active or post cancerous disease (ongoing radiation-/chemotherapy treatment),
- patients with liver diseases (ALT > 3x border line ) except for patients with fatty live disease,
- chronic kidney disease eGFR <30 ml/ 1,73m2 / min,
- acute inflammation CRP > 5mg/dl,
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- unstable ischeamic heart disease, state after bypass surgery, implanted heart stimulator- (cardioverter, defibrillator - ICD, heart pacemaker), endovascular prosthesis,
- patients after an ischemic or haemorrhagic stroke (<6 months)
- post STEMI patients with a drug-eluting stent implantation, nSTEMI (<12 months)
- inherited metabolic disorders: phenylketonouria, galactosaemia
- autoimmune diseases (an acute thyroiditis, celiac disease, systemic connective tissue disease, haemolytic anemia, vitiligo, addison's disease, hyperbilirubinemia),
- non specific enteneritis (Crohn's disease, ulcerative colonitis)
- pregnancy,
- psychological disorders, eating disorders such as anorexia, bulimia,
- antibiotic therapy, steroid therapy, (ongoing)
- drug, alcohol addiction (a daily consumption of more then 1 portion of alcohol).
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 61-323
Agnieszka Zawada, 604595007, aga.zawada@gmail.com
About this study
Official title: Assessment of Anthropometric Parameters, Protein and Metabolic Profile and Function of the Respiratory System in Obese Patients Reducing Their Body Mass Under Controlled Conditions
Obesity is currently considered an increasingly more severe social and health related problem. The World Health Organization qualified obesity as a chronic disease along with circulatory diseases, diabetes, cancer and respiratory diseases. The principal physiological methods of treatment for this disease are diet and exercise. The aim of the study is assess anhtropometric parameters, metabolic and proteomic profile and respiratory truck function in obese patients reducing body weight during 21 days course of calorie restriction and physical activity.
Read the detailed description
THE AIM OF THE STUDY:
Determining changes in anthropometric parameters, both the protein and metabolic profile as well as changes in the respiratory system functional testing in obese patients, in whom an attempt to reduce body mass (through dietary treatment and physical activity), under controlled conditions (over a period of a 21-day hospitalization) was made.
RESEARCH METHODOLOGY:
The study will be conducted on a group of a 100 persons with obesity who fulfilled the inclusion criteria (index BMI>30 kg/m2/ and an increased adipose tissue content assessed by the electrical bioimpedance method)
RESEARCH PLAN
- The research will include studies conducted in The Department and Clinic of Gastroenterology, Dietetics and Internal Medicine in Poznan, performed by members of the research team, before and after a 21-day weight loss cycle:
- The assessment of anthropometric parameters (height, body mass, BMI, the waist and hip circumference, the WHR index) and the assessment of the body adipose tissue content using the electrical bioimpedance method, with TANITA MC-980 MA TANITA AB140 ViScan device).
- The detailed medical history, considering other parameters that may influence an increase in body mass, based on a detailed specially prepared questionnaire (regarding disease history, socio-economical data and eating habits).
- Objective and subjective assessment, systolic and diastolic blood pressure measurement (two-time measurement with the sphygmomanometer using the Korotkow method, in a sitting position, after a 5 minute rest), as well as a systolic and diastolic blood pressure measurement in reaction to verticalization.
The following parameters will be assessed in a study group:
- Lipid parameters (the total cholesterol density, HDL fraction, LDL and the triglycerides in the serum) using the enzymatic method. The HDL cholesterol will be calculated based on the following formula: nonHDL cholesterol = total cholesterol - HDL fraction cholesterol and the ratio TG/HDL will be calculated as well.
- Inflammatory response markers assessment, OB and CRP, using a standard method
- Liver function assessment (ALT, AST, GGTP) using a standard method.
- Kidney function assessment (the creatinine concentration in the serum including the estimated indicator of glomerular filtration rate (eGFR) according to the Modification of Diet Renal Disease Study Equation (MDRD) norm: 90-120ml/min/1,73 m². CChN will be classified according to the estimated indicator of glomerular filtration rate: stage G1 (eGFR≥90 ml/min/1,73 m²), stage G2 (eGFR 60-89 ml/min/1,73 m²), stage G3a (eGFR45-59 ml/min/1,73 m²), stage G3b (eGFR30-45 ml/min/1,73 m²) stage G4 (eGFR 5-29 ml/min/1,73 m²) and stage G5 (eGFR<15 ml/min/1,73 m² or dialysis treatment). [1] The plan is to assess, within the study group, the albumin/creatinine index in a morning urine sample. The value of the albumin/creatinine index>30mg/g will be considered positive.
- The evaluation of markers: alfa-fetoprotein, Ca19,9, CEA using a standard method.
Furthermore, the patients will be asked to fill out additional questionnaires:
- Questionnaire evaluating the eating behavior and opinion on food and nutrition (QEB) and a Physical activity questionnaire
- Questionnaires assessing the quality of sleep: (Athens Insomnia Scale and Pittsburgh Sleep Quality Index (PSQI).
- Sleep apnea scale
- Psychological surveys: Multidimensional Health Locus and Control Scale (MHLC), Satisfaction with Life Scale (SWLS), Acceptance of Illness Scale (AIS)
- Additionally for patients with accompanying diabetes: Problem Areas in Diabetes (PAID) Diabetes Treatment Questionnaire (DTSQ) II. 21-day stay in the Greater Poland Pulmonology and Thoracic Surgery Centre, The Department of Pulmonology and Rehabilitation (Unit in Ludwikowo near Poznan)
Indications for hospitalization:
- Obesity disenabling professional work and social function performing.
- Necessity of body mass reduction to improve lipid parameters
- Sleep disorder caused by excess body mass (sleep apnea syndrome)
- Pre-diabetes or diabetes related to accompanying obesity
- Osteoarticular system disorders related to obesity disenabling the execution of planned orthopedic procedures
The following will be conducted on subjects of the study during hospitalization:
- A 21-day body mass reduction attempt will be implemented under sanatorial conditions. A rational hypo-calorie diet will be applied to all patients (calorie reduction proportional to the BMR calculated into actual body mass, macro-elements: 15-20% protein, 25-30% fat, 50-55% carbohydrates, simple sugar content <5%, dietary fiber 30g)
- Throughout a period of the weight loss program the following will be implemented: standard motor rehabilitation - kinesitherapy (2 x a day for 25 minutes), stationary bike training (1x a day for 10 minutes) as well as passive mechanical exercises (1x a day for 15 minutes), abdominal muscle exercises (1x a day with an increasing, by 10, number of repetitions starting with 30).
- Every patient will also take two physiotherapeutic treatments recommended by a physiotherapist (laser, ultrasounds, TENS, magnetic field, iontophoresis).
- The following respiratory system tests will be conducted before the beginning as well as on the 21-st day of the weight loss cycle: arterial blood gasometry, spirometry, ergospirometry, body plethysmography, diffusing capacity of the lung for carbon dioxide (DLCO).
- Furthermore, on the starting day of the program as well as after 21 days, the measurement of neck circumference and neck adipose tissue will be performed.
- Each patient, who will be taking part in the study, will be educated in the aspect of correct nutrition and rational reduction diet rules (3 meetings -30 minutes each, conducted at 7 day intervals).
- Furthermore, the oxidative stress parameters and the inflammatory response markers will be evaluated both at the beginning and at the end of the hospitalization period.
III. The assessment of amino acid concentration and the metabolic profile evaluation will be performed in the Department of Inorganic and Analytical Chemistry.
- Evaluation of the protein profile will be performed using the mass spectrometer MALDI ToF/ToF,
- The serous amino acid concentration will be performed using the mass spectrometer QTRAP 4000)
- The Biocrates AbsolutelDQ p180 Kit will be used to evaluate the metabolic panel (glycerolophospholipids, sphingolipids).
- Venous blood, in the amount of 20 ml will be used in order to assess parameters listed above. Determination of the above parameters will be performed twice, before and after the end of each stage (40 ml of venous blood will be sampled from each patient throughout the duration of the study).
IV. The evaluation of hormones released by the muscle and adipose tissue, the concentration of free oxygen radicals, and the total oxidation capacity in plasma will be assessed from blood samples obtained at the beginning and at the end of the 21 day study period in The Academy of Physical Education The Department of Physiology.
- Conditions
- Obesity, Diet Modification, Physical Activity
- Being tested
- diet and physical activity
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet and physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| diet and physical activity | Not described Receives: Behavioral: diet and physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
adipose tissue
The assessment of the body adipose tissue content using the electrical bioimpedance device- TANITA MC-980 MA.( Percentage )
Measured: after 12 months
Satisfaction with Life Scale
SWLS Questionaire
Measured: after 12 months
Respiratory system tests
spirometry (%)
Measured: after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Feb 2016
- Primary completion21 Dec 2018 (estimated)
- Study completion21 Dec 2020 (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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Zawada, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346421
- Sponsor's protocol ID
- AofMPRinO
- Status last verified
- Nov 2017
- First submitted
- 4 Oct 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Anthropometric Parameters, Protein and Metabolic Profile and Function of the Respiratory System in Obese Patients Reducing Their Body Mass Under Controlled Conditions
- ClinicalTrials.gov ID
- NCT03346421
- Acronym / sponsor ID
- AofMPRinO
- Conditions
- Obesity, Diet Modification, Physical Activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 21 Dec 2018 (estimated)
- Study completion
- 21 Dec 2020 (estimated)
- First posted
- 17 Nov 2017 (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.
Obesity is currently considered an increasingly more severe social and health related problem. The World Health Organization qualified obesity as a chronic disease along with circulatory diseases, diabetes, cancer and respiratory diseases. The principal physiological methods of treatment for this disease are diet and exercise. The aim of the study is assess anhtropometric parameters, metabolic and proteomic profile and respiratory truck function in obese patients reducing body weight during 21 days course of calorie restriction and physical activity.
Detailed description
THE AIM OF THE STUDY:
Determining changes in anthropometric parameters, both the protein and metabolic profile as well as changes in the respiratory system functional testing in obese patients, in whom an attempt to reduce body mass (through dietary treatment and physical activity), under controlled conditions (over a period of a 21-day hospitalization) was made.
RESEARCH METHODOLOGY:
The study will be conducted on a group of a 100 persons with obesity who fulfilled the inclusion criteria (index BMI>30 kg/m2/ and an increased adipose tissue content assessed by the electrical bioimpedance method)
RESEARCH PLAN
- The research will include studies conducted in The Department and Clinic of Gastroenterology, Dietetics and Internal Medicine in Poznan, performed by members of the research team, before and after a 21-day weight loss cycle:
- The assessment of anthropometric parameters (height, body mass, BMI, the waist and hip circumference, the WHR index) and the assessment of the body adipose tissue content using the electrical bioimpedance method, with TANITA MC-980 MA TANITA AB140 ViScan device).
- The detailed medical history, considering other parameters that may influence an increase in body mass, based on a detailed specially prepared questionnaire (regarding disease history, socio-economical data and eating habits).
- Objective and subjective assessment, systolic and diastolic blood pressure measurement (two-time measurement with the sphygmomanometer using the Korotkow method, in a sitting position, after a 5 minute rest), as well as a systolic and diastolic blood pressure measurement in reaction to verticalization.
The following parameters will be assessed in a study group:
- Lipid parameters (the total cholesterol density, HDL fraction, LDL and the triglycerides in the serum) using the enzymatic method. The HDL cholesterol will be calculated based on the following formula: nonHDL cholesterol = total cholesterol - HDL fraction cholesterol and the ratio TG/HDL will be calculated as well.
- Inflammatory response markers assessment, OB and CRP, using a standard method
- Liver function assessment (ALT, AST, GGTP) using a standard method.
- Kidney function assessment (the creatinine concentration in the serum including the estimated indicator of glomerular filtration rate (eGFR) according to the Modification of Diet Renal Disease Study Equation (MDRD) norm: 90-120ml/min/1,73 m². CChN will be classified according to the estimated indicator of glomerular filtration rate: stage G1 (eGFR≥90 ml/min/1,73 m²), stage G2 (eGFR 60-89 ml/min/1,73 m²), stage G3a (eGFR45-59 ml/min/1,73 m²), stage G3b (eGFR30-45 ml/min/1,73 m²) stage G4 (eGFR 5-29 ml/min/1,73 m²) and stage G5 (eGFR<15 ml/min/1,73 m² or dialysis treatment). [1] The plan is to assess, within the study group, the albumin/creatinine index in a morning urine sample. The value of the albumin/creatinine index>30mg/g will be considered positive.
- The evaluation of markers: alfa-fetoprotein, Ca19,9, CEA using a standard method.
Furthermore, the patients will be asked to fill out additional questionnaires:
- Questionnaire evaluating the eating behavior and opinion on food and nutrition (QEB) and a Physical activity questionnaire
- Questionnaires assessing the quality of sleep: (Athens Insomnia Scale and Pittsburgh Sleep Quality Index (PSQI).
- Sleep apnea scale
- Psychological surveys: Multidimensional Health Locus and Control Scale (MHLC), Satisfaction with Life Scale (SWLS), Acceptance of Illness Scale (AIS)
- Additionally for patients with accompanying diabetes: Problem Areas in Diabetes (PAID) Diabetes Treatment Questionnaire (DTSQ) II. 21-day stay in the Greater Poland Pulmonology and Thoracic Surgery Centre, The Department of Pulmonology and Rehabilitation (Unit in Ludwikowo near Poznan)
Indications for hospitalization:
- Obesity disenabling professional work and social function performing.
- Necessity of body mass reduction to improve lipid parameters
- Sleep disorder caused by excess body mass (sleep apnea syndrome)
- Pre-diabetes or diabetes related to accompanying obesity
- Osteoarticular system disorders related to obesity disenabling the execution of planned orthopedic procedures
The following will be conducted on subjects of the study during hospitalization:
- A 21-day body mass reduction attempt will be implemented under sanatorial conditions. A rational hypo-calorie diet will be applied to all patients (calorie reduction proportional to the BMR calculated into actual body mass, macro-elements: 15-20% protein, 25-30% fat, 50-55% carbohydrates, simple sugar content <5%, dietary fiber 30g)
- Throughout a period of the weight loss program the following will be implemented: standard motor rehabilitation - kinesitherapy (2 x a day for 25 minutes), stationary bike training (1x a day for 10 minutes) as well as passive mechanical exercises (1x a day for 15 minutes), abdominal muscle exercises (1x a day with an increasing, by 10, number of repetitions starting with 30).
- Every patient will also take two physiotherapeutic treatments recommended by a physiotherapist (laser, ultrasounds, TENS, magnetic field, iontophoresis).
- The following respiratory system tests will be conducted before the beginning as well as on the 21-st day of the weight loss cycle: arterial blood gasometry, spirometry, ergospirometry, body plethysmography, diffusing capacity of the lung for carbon dioxide (DLCO).
- Furthermore, on the starting day of the program as well as after 21 days, the measurement of neck circumference and neck adipose tissue will be performed.
- Each patient, who will be taking part in the study, will be educated in the aspect of correct nutrition and rational reduction diet rules (3 meetings -30 minutes each, conducted at 7 day intervals).
- Furthermore, the oxidative stress parameters and the inflammatory response markers will be evaluated both at the beginning and at the end of the hospitalization period.
III. The assessment of amino acid concentration and the metabolic profile evaluation will be performed in the Department of Inorganic and Analytical Chemistry.
- Evaluation of the protein profile will be performed using the mass spectrometer MALDI ToF/ToF,
- The serous amino acid concentration will be performed using the mass spectrometer QTRAP 4000)
- The Biocrates AbsolutelDQ p180 Kit will be used to evaluate the metabolic panel (glycerolophospholipids, sphingolipids).
- Venous blood, in the amount of 20 ml will be used in order to assess parameters listed above. Determination of the above parameters will be performed twice, before and after the end of each stage (40 ml of venous blood will be sampled from each patient throughout the duration of the study).
IV. The evaluation of hormones released by the muscle and adipose tissue, the concentration of free oxygen radicals, and the total oxidation capacity in plasma will be assessed from blood samples obtained at the beginning and at the end of the 21 day study period in The Academy of Physical Education The Department of Physiology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diet and physical activity | – | Behavioral: diet and physical activity |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be conducted on a group of a 100 persons with obesity who fulfilled the inclusion criteria (index BMI>30 kg/m2/ and an increased adipose tissue content assessed by the electrical bioimpedance method).
Key inclusion criteria (4 listed)
- patient's age: above 18 years of age
- BMI obesity >30kg/m2
- increased content of overall adipose tissue measured by bioelectrical impendance method
- consent to take part in the study
Key exclusion criteria (16 listed)
- positive electrocardiographic stress test
- staying on a vegetarian or any other alternative diet
- patients with active or post cancerous disease (ongoing radiation-/chemotherapy treatment),
- patients with liver diseases (ALT > 3x border line ) except for patients with fatty live disease,
- chronic kidney disease eGFR <30 ml/ 1,73m2 / min,
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 and physical activity | Behavioural | diet and physical activity |
Primary outcome
adipose tissue
Time frame: after 12 months
The assessment of the body adipose tissue content using the electrical bioimpedance device- TANITA MC-980 MA.( Percentage )
Satisfaction with Life Scale
Time frame: after 12 months
SWLS Questionaire
Respiratory system tests
Time frame: after 12 months
spirometry (%)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
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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.
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 Obesity and Diet Modification, run by Poznan University of Medical Sciences at 1 site in Poland.
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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 17 Nov 2017. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adipose tissue (time frame: after 12 months). The study lists 3 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 17 Nov 2017; AzTrials last refreshed its copy on 6 Nov 2026.