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Exercise and Genes in Obese (EGO) (EGO)

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ClinicalTrials.gov Identifier: NCT02311738
Recruitment Status : Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : December 7, 2018
Sponsor:
Collaborators:
Telemark University College
Vestfold University College
Duke University
University of Agder
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Jarle Berge, Sykehuset i Vestfold HF

Brief Summary:

Regular exercise has several positive health effects including increased physical fitness and muscle mass. It is well known that increased muscle mass is associated with increased resting energy expenditure which may facilitate weight loss and maintenance. Previous studies have, however, failed to show any consistent association between the intensity of physical exercise and energy expenditure, or relate the variance in these adaptations to genetic variability. Whether high-intensity exercise (HIE) is associated with improved health related quality of life in severely obese patients remains unknown.

This PhD-project is based on a planned randomised controlled study including 50 or more treatment seeking morbidly obese patients who will be randomised to either a 24 week moderate-intensity exercise (MIE) programme or a 24 week high-intensity exercise (HIE) programme. The investigators main hypothesis is that patients randomised to the HIE-program will achieve higher energy expenditure during rest and physical activity after treatment than those allocated to the MIE-programme. In addition, the investigators hypothesise that the HIE-group will achieve a better health related quality of life than the MIE-group after treatment. The investigators also hypothesize that inter-individual variability in adaptation to the two training regimens may be due to genetic factors. If the investigators hypotheses are confirmed, this project might have beneficial clinical implications for future obesity treatment strategies.


Condition or disease Intervention/treatment Phase
Obesity Other: Training intensity intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of Exercise and Genes on Energy Expenditure, Appetite and Quality of Life in Morbidly Obese Patients
Actual Study Start Date : January 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High intensity training group

HIE will consist of the following:

  1. 10 minute warm up at 70% of maximal heart rate.
  2. 4 minute exercise intervals at 90-95% of maximal heart rate.
  3. 4 minute interval bouts repeated 4 times.
  4. Between each bouts there will be a 3 minute active recovery at 70% of maximal heart rate
  5. After all four bouts are completed; 5 minute cool-down at 70% of maximal heart rate.
Other: Training intensity intervention
High intensity training group describes the group performing high intensity exercise intervention. Moderate intensity training group describes the the group performing moderate exercise intervention
Other Name: EGO-HIT

Experimental: Moderate intensity training group

MIE will consist of the following:

  1. 10 minute warm up at 50% of maximal heart rate.
  2. 35 minutes exercise at 70% of maximal heart rate.
  3. 4 minute cool-down at 50% of maximal heart rate.
Other: Training intensity intervention
High intensity training group describes the group performing high intensity exercise intervention. Moderate intensity training group describes the the group performing moderate exercise intervention
Other Name: EGO-HIT




Primary Outcome Measures :
  1. Energy expenditure during rest and physical activity [ Time Frame: up to 24 weeks ]
    Resting energy expenditure and energy expenditure (EE) during volitional activity will be measured by indirect calorimetry one week before the exercise intervention period starts, and repeated after each exercise period. Increasing the aerobic work capacity is supposed to give the same proportional increase in energy expenditure at any given maximal intensity. Therefore, indirect calorimetry measurements will be performed at wk 8 and 16 in order to recalculate the EE


Secondary Outcome Measures :
  1. Genetic susceptibility [ Time Frame: 8, 12 and 24 weeks ]
    We hypothesize that inter-individual variability in adaptation/response to the two training regimens may also be due to genetic factors. We have designed a gene panel consisting of recognized and previously reported risk genes/variants with flanking sequences relevant for exercise (VO2max), participation in physical activity, obesity, diabetes, asthma and obesity related sub-phenotypes. The panel covers 1.2 Mb and includes 299 genes (exons with exon-intron junctions) and 1468 intronic and intergenic SNPs. Next-generation sequencing will be performed using a gene panel of selected genes/genetic regions by Illumina Nextera technology. The method involves enzymatic fragmentation of DNA and probe-based enrichment. The samples will be sequenced (paired-end, 2x100 bp) on a HiScanSQ. All wet lab methods (with other gene panels) are ISO15189 certified and in routine use at Unit for Medical Genetics at Telemark Hospital.

  2. Quality of life [ Time Frame: 8, 12 and 24 weeks ]

    The following questionnaires will be used to assess quality of life, obesity related symptoms, gastrointestinal symptoms, affective symptoms, and eating behaviour:

    1. Short Form Quality of Life questionnaire (SF-36)
    2. Impact on Weight Questionnaire IWQOL-Lite.
    3. Weight-Related Symptom Measure (WRSM)

  3. Eating behavior [ Time Frame: 24 weeks ]

    Three validated questionnaires will be used for the assessment of psychological eating behavior.

    1. Power of Food Scale
    2. Binge Eating Scale (BES)
    3. Three factor eating questionnaire (TFEQ -R21)

  4. Appetite control [ Time Frame: 8, 12 and 24 weeks ]
    Patient self-appraisal of hunger and fullness will be assessed during fasting and after a standardised breakfast every 30 minutes (for a period of 3hours) using visual analogue scales.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Treatment seeking weight stable morbidly obese patients (BMI ≥ 40 kg/m2 or BMI 35 to 39.9 kg/m2 with ≥ 1 co morbidity) attending the outpatient Obesity Center, Vestfold Hospital Trust, will be informed about this RCT .

Exclusion Criteria:

  • Uncompensated heart failure
  • Recent myocardial infarction or stroke (<½ years)
  • Severe arrhythmia or heart failure
  • Unstable angina pectoris
  • Renal failure
  • Pregnancy
  • Severe eating disorders
  • Active substance abuse
  • Being on a diet
  • Taking medication known to affect appetite or metabolism (including thyroxin).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311738


Locations
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United States, North Carolina
Duke University School of Medicine
Durham, North Carolina, United States, 27708
Norway
Vestfold University College
Horten, Raveien, Norway, 3184
Telemark University College
Bø, Norway, 3800
University in Agder
Kristiansand, Norway, 4630
Norges Teknisk-naturvitenskapelig Universitet
Trondheim, Norway, 7491
Vestfold Hospital Trust
Tønsberg, Norway, 3103
Sponsors and Collaborators
Jarle Berge
Telemark University College
Vestfold University College
Duke University
University of Agder
Norwegian University of Science and Technology
Investigators
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Study Director: Jøran Hjelmesæth, professor The Hospital of Vestfold

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Responsible Party: Jarle Berge, PhD-Fellow, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT02311738     History of Changes
Other Study ID Numbers: EGO
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

Keywords provided by Jarle Berge, Sykehuset i Vestfold HF:
Exercise and Genes in Obese (EGO)