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

NCT03346421 | Unknown

• 1 other identifier: AofMPRinO
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Diet Modification; Physical Activity

Outcome Measures

Primary Outcomes (3)

• adipose tissue

  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

  SWLS Questionaire

  after 12 months

• Respiratory system tests

  spirometry (%)

  after 12 months

Study Arms (1)

diet and physical activity

Behavioral: diet and physical activity

Interventions

diet and physical activity BEHAVIORAL

diet and physical activity

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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)

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 61-323, Poland

RECRUITING

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: November 17, 2017
• Study Start: February 1, 2016
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2020
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

PL (1)