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Energy Expenditure From ECAL Indirect Calorimeter in a Multicomponent Weight Management Service (ECAL)

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ClinicalTrials.gov Identifier: NCT03638895
Recruitment Status : Unknown
Verified August 2018 by Prof. John Wilding, University of Liverpool.
Recruitment status was:  Not yet recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Collaborators:
Metabolic Health Solutions UK
Medtronic
Information provided by (Responsible Party):
Prof. John Wilding, University of Liverpool

Brief Summary:
Whether greater weight loss is as a result of a smaller reduction in energy expenditure with caloric restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. In some cases, relatively reduced rates of 24h EE predict weight gain in some populations who have high prevalence of obesity. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.

Condition or disease Intervention/treatment Phase
Obesity Severe Obesity Sleep Apnoea Device: ECAL Indirect Calorimeter Behavioral: Diet, exercise & behaviour modification therapy Not Applicable

Detailed Description:
Weight loss is important to improve overall health and reduce risk of obesity-related comorbidities such as diabetes. Numerous studies performed on individuals with predisposed genetic propensity to obesity who are deemed to be metabolically 'thrifty', require further structured intensification of caloric restriction and change in physical activity in order to achieve weight loss. Whether greater weight loss is as a result of smaller reduction in energy expenditure with calorie restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The ECAL device also measures the respiratory quotient (RQ) which is the ratio of the volume of carbon dioxide expired to that of oxygen consumed by the individual for every breath. Previous studies demonstrated variability in role of RQ in predicting weight loss, but individuals who demonstrated an RQ in the lower range (<0.72) were more likely to maintain the weight-loss achieved on a caloric restriction and avoid a weight loss rebound as compared to those with RQ in the higher range (>0.75). This suggests that RQ could prove useful in clinical practice as a prognostic marker for long-term effectiveness of low- and very-low-calorie diets used to induce weight loss. Baltimore Longitudinal Study on Aging shared a similar finding that fasting RQ or respiratory exchange ratio adjusted for age, BMI, and fat free mass was positively related to weight change. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Care Provider)
Masking Description: Double (Participant, Practitioner) Energy expenditure information (resting energy expenditure & respiratory quotient) is withheld from participant and practitioner providing care to participants in the control group.
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Evaluate Impact of Energy Expenditure Information From Indirect Calorimeter on the Outcome of Weight Loss During a Standardised Multicomponent Weight Management Intervention in Non-diabetic & Pre-diabetic Obese Subjects
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ECAL group
Intervention group (ECAL) - practitioners and participants receive measured energy information from ECAL indirect calorimeter including resting energy expenditure and respiratory quotient to diagnose, manage and advise on modification of caloric restriction and physical activity level. Energy information also allows participant and practitioner to monitor and compare changes to their metabolic health throughout the duration of intervention.
Device: ECAL Indirect Calorimeter
The ECAL is an open-circuit portable indirect calorimeter that measures both volume of CO2 expired and O2 consumed using a small mixing chamber. Participants will breathe through a mouthpiece with a nose clip applied whilst lying in a restful and comfortable position for 15 minutes. ECAL device will provide breath-by-breath measurements of the resting energy expenditure and respiratory quotient which will allow both practitioners and participants to monitor their metabolic health and compare the effect of dietary and physical activity intervention over the course of the structured intensive lifestyle intervention (24-weeks).

Placebo Comparator: SC group
Standard care (SC) - participants receive standard care (diet, exercise & behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention.
Behavioral: Diet, exercise & behaviour modification therapy
Standard care (SC) - participants receive standard care (diet, exercise & behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention.




Primary Outcome Measures :
  1. Magnitude of weight loss (in kg) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Resting metabolic rate (RMR) [ Time Frame: 6 months ]
    The measurement of number of calories that the body burns at rest in 24 hours, expressed as kcal/day

  2. Respiratory Quotient (RQ) [ Time Frame: 6 months ]
    The ratio of carbon dioxide production to oxygen consumption and reflects the relative contribution of fat, carbohydrate, and protein in the oxidation fuel mixture.

  3. Secretion of gut hormones (GLP-1, GIP, PYY) [ Time Frame: 6 months ]
    Secretion of appetite regulating gut hormone (GLP-1, GIP, PYY) in fasting and post-prandial phase

  4. Glycaemic variability [ Time Frame: 6 months ]
    Change from baseline in the swings in blood glucose levels, expressed as the mean amplitude of glycaemic excursion (MAGE)

  5. Insulin sensitivity [ Time Frame: 6 months ]
    Change from baseline in the measure of insulin rise in response to blood sugar levels, expressed as the homeostasis model assessment (HOMA). HOMA estimates steady state beta cell function and insulin sensitivity as percentages of the normal reference population.

  6. Sensory Neuropathy Testing in Prediabetic Obese Individuals [ Time Frame: 6 months ]
    Change from baseline in vibration perception threshold measurement using the neurothesiometer

  7. Douleur Neuropathique en4 Questions (DN4) [ Time Frame: 6 months ]
    Change from baseline in Douleur Neuropathique en4 Questions (DN4) using seven interview questions and three physical tests.

  8. Visual analogue score [ Time Frame: 6 months ]
    Change from baseline in visual analogue score of pain, expressed as Units on a scale of 0 to 100. where 0 is worst possible health and 100 is the best possible health.

  9. modified Total Neuropathy Score [ Time Frame: 6 months ]
    Change from baseline in modified Total Neuropathy Score (mTNS) questionnaire expressed as the average of the five components

  10. Brief Pain Inventory Short Form [ Time Frame: 6 months ]
    Change from baseline in brief pain inventory short form (BPI-SF) scored as the mean of the seven interference items.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI > or equivalent to 30 kg/m2 to - 60 kg/m2
  • Stable weight (change of <5% within 12 weeks before screening based on medical history)
  • Subjects are well-motivated, capable and willing to learn how to undergo indirect calorimetry testing
  • Willing and able to adhere to prohibitions and restrictions specified within this protocol

For Subjects participating in the glycaemic variability sub-study:

  • Subject understands instructions on the use of continuous glucose monitor sensor and is willing to undergo appropriate training and testing

Exclusion Criteria:

  • Taking weight loss medication within 12 weeks prior to randomisation
  • Previous or planned bariatric surgery
  • History of Type 1, Type 2 diabetes mellitus, DKA or diabetes secondary to pancreatitis
  • Has HbA1c > or equal to 6.5% or Fasting Plasma Glucose > or equal to 7.0 mmol/L at screening.

NOTE: a one-time repeat measurement is allowed, if value of HbA1c and/or FPG is not consistent with prior values

  • History of obesity with a known secondary cause (Cushing's disease/syndrome)
  • Oral corticosteroid use (except in the short term use of a 7-10 day course)
  • Ongoing, inadequately controlled thyroid disorder defined as thyroid-stimulating hormone > 6 mIU/litre or < 0.4 mIU/litre
  • History of malignancy within 3 years before screening (or diagnosis of malignancy within this period)
  • estimated glomerular filtration rate < 30 ml/min/1.73m2 on serum testing
  • Alanine aminotransferase level is <2.0 times the upper limit of normal or total bilirubin is >1.5 times the upper limit of normal at screening
  • Other major illness likely to preclude participation in the trial
  • History of glucagonoma
  • A myocardial infarction, unstable angina, revascularisation procedure (stent or bypass graft surgery) or cerebrovascular accident within 12 weeks before screening

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): NCT03638895


Contacts
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Contact: John PH Wilding, DM FRCP 0151 529 5885 ext 5885 j.p.h.wilding@liverpool.ac.uk
Contact: Jonathan ZM Lim, MBChB 0151 529 5917 ext 5917 j.z.lim@liverpool.ac.uk

Sponsors and Collaborators
University of Liverpool
Metabolic Health Solutions UK
Medtronic
Investigators
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Principal Investigator: John Wilding, DM FRCP University of Liverpool
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. John Wilding, Professor of Medicine & Honorary Consultant Physician, Obesity and Endocrinology Research, Theme Lead for Metabolism and Nutrition, University of Liverpool
ClinicalTrials.gov Identifier: NCT03638895    
Other Study ID Numbers: UoL001379
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. John Wilding, University of Liverpool:
weight management
obesity
severe obesity
structured dietary intervention
calorie restriction
indirect calorimetry
resting energy expenditure
resting metabolic rate
respiratory quotient
substrate oxidation
glycemic variability
insulin sensitivity
peripheral neuropathy
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight