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Anthropometric Parameters, Metabolic Profile and Function of the Respiratory System in Obese Patients

14 novembre 2017 aggiornato da: Agnieszka Zawada, Poznan University of Medical Sciences

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.

Panoramica dello studio

Descrizione dettagliata

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

I. 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:

  1. 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).
  2. 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).
  3. 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:

  1. 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.
  2. Inflammatory response markers assessment, OB and CRP, using a standard method
  3. Liver function assessment (ALT, AST, GGTP) using a standard method.
  4. 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.
  5. The evaluation of markers: alfa-fetoprotein, Ca19,9, CEA using a standard method.

Furthermore, the patients will be asked to fill out additional questionnaires:

  1. Questionnaire evaluating the eating behavior and opinion on food and nutrition (QEB) and a Physical activity questionnaire
  2. Questionnaires assessing the quality of sleep: (Athens Insomnia Scale and Pittsburgh Sleep Quality Index (PSQI).
  3. Sleep apnea scale
  4. Psychological surveys: Multidimensional Health Locus and Control Scale (MHLC), Satisfaction with Life Scale (SWLS), Acceptance of Illness Scale (AIS)
  5. 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:

  1. Obesity disenabling professional work and social function performing.
  2. Necessity of body mass reduction to improve lipid parameters
  3. Sleep disorder caused by excess body mass (sleep apnea syndrome)
  4. Pre-diabetes or diabetes related to accompanying obesity
  5. 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:

  1. 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)
  2. 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).
  3. Every patient will also take two physiotherapeutic treatments recommended by a physiotherapist (laser, ultrasounds, TENS, magnetic field, iontophoresis).
  4. 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).
  5. 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.
  6. 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).
  7. 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.

  1. Evaluation of the protein profile will be performed using the mass spectrometer MALDI ToF/ToF,
  2. The serous amino acid concentration will be performed using the mass spectrometer QTRAP 4000)
  3. The Biocrates AbsolutelDQ p180 Kit will be used to evaluate the metabolic panel (glycerolophospholipids, sphingolipids).
  4. 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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

100

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Poznan, Polonia, 61-323
        • Reclutamento
        • Poznan University of Medical Sciences
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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).

Descrizione

Inclusion Criteria:

  1. patient's age: above 18 years of age
  2. BMI obesity >30kg/m2
  3. increased content of overall adipose tissue measured by bioelectrical impendance method
  4. consent to take part in the study

Exclusion Criteria:

  1. positive electrocardiographic stress test
  2. staying on a vegetarian or any other alternative diet
  3. patients with active or post cancerous disease (ongoing radiation-/chemotherapy treatment),
  4. patients with liver diseases (ALT > 3x border line ) except for patients with fatty live disease,
  5. chronic kidney disease eGFR <30 ml/ 1,73m2 / min,
  6. acute inflammation CRP > 5mg/dl,
  7. unstable ischeamic heart disease, state after bypass surgery, implanted heart stimulator- (cardioverter, defibrillator - ICD, heart pacemaker), endovascular prosthesis,
  8. patients after an ischemic or haemorrhagic stroke (<6 months)
  9. post STEMI patients with a drug-eluting stent implantation, nSTEMI (<12 months)
  10. inherited metabolic disorders: phenylketonouria, galactosaemia
  11. autoimmune diseases (an acute thyroiditis, celiac disease, systemic connective tissue disease, haemolytic anemia, vitiligo, addison's disease, hyperbilirubinemia),
  12. non specific enteneritis (Crohn's disease, ulcerative colonitis)
  13. pregnancy,
  14. psychological disorders, eating disorders such as anorexia, bulimia,
  15. antibiotic therapy, steroid therapy, (ongoing)
  16. drug, alcohol addiction (a daily consumption of more then 1 portion of alcohol).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
diet and physical activity

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
adipose tissue
Lasso di tempo: after 12 months
The assessment of the body adipose tissue content using the electrical bioimpedance device- TANITA MC-980 MA.( Percentage )
after 12 months
Satisfaction with Life Scale
Lasso di tempo: after 12 months
SWLS Questionaire
after 12 months
Respiratory system tests
Lasso di tempo: after 12 months
spirometry (%)
after 12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 febbraio 2016

Completamento primario (Anticipato)

21 dicembre 2018

Completamento dello studio (Anticipato)

21 dicembre 2020

Date di iscrizione allo studio

Primo inviato

4 ottobre 2017

Primo inviato che soddisfa i criteri di controllo qualità

14 novembre 2017

Primo Inserito (Effettivo)

17 novembre 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 novembre 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 novembre 2017

Ultimo verificato

1 novembre 2017

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • AofMPRinO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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