- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06309238
Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial (LightBAR)
Intensive Weight Loss Intervention Versus Bariatric Surgery for Adults With Severe and Complex Obesity: the LightBAR Randomised Trial. Lighthouse Consortium on Obesity Management (LightCOM) Trial no 4
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the LightBAR trial, an intensive weight loss (IWL) intervention will be compared with bariatric surgery. The IWL consists of three phases:
'Induction' phase (week 0-12 after randomisation): total dietary replacement (TDR) programme and behavioural support with weight loss medication (WLM) if rate of weight loss is insufficient.
'Weight loss continuation' phase (week 13-32 after randomisation): progression of dietary programme including reduction in use of TDR products, reintroduction of healthy foods, with behavioural support, introduction of physical activity, WLM (as required).
'Maintenance' phase (week 33-104 after randomisation): Continued healthy diet and physical activity with WLM (if required), with return to induction phase if weight regain occurs induction, weight loss continuation, maintenance. The IWL lasts two years, and includes total dietary replacements, behavioural support, and weight loss medication. Bariatric surgery will be standard Roux-en-Y gastric bypass or sleeve gastrectomy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kirstine N Bojsen-Møller, MD, PhD
- Phone Number: +45 3862 3862
- Email: kirstine.nyvold.bojsen-moeller@regionh.dk
Study Contact Backup
- Name: Susan Jebb, Professor
- Phone Number: +44 (0) 1865 617 847
- Email: lightcom@phc.ox.ac.uk
Study Locations
-
-
-
Aarhus, Denmark, 8200
- Not yet recruiting
- Steno Diabetes Center Aarhus, Aarhus Universitets Hospital
-
Contact:
- Jens Bruun
-
Esbjerg, Denmark, 6700
- Not yet recruiting
- The Department of Medicine and Department of Surgery, University Hospital of South West Jutland
-
Contact:
- Claus Borg Juhl
-
Hvidovre, Denmark, 2650
- Recruiting
- The Department of Medicine and the Gastro Unit, Copenhagen University Hospital - Amager and Hvidovre
-
Contact:
- Kirstine N Bojsen-Møller
-
Køge, Denmark, 4600
- Not yet recruiting
- The Department of Medicine and the Department of Surgery, Zealand University Hospital Køge
-
Contact:
- Merethe Hansen
-
Viborg, Denmark, 8800
- Not yet recruiting
- Department of Surgery, Viborg Regional Hospital
-
Contact:
- Peter Rask
-
-
-
-
-
Bristol, United Kingdom, BS10 5NB
- Not yet recruiting
- Southmead Hospital, North Bristol NHS Trust
-
Contact:
- Dimitri Pournaras
-
Southampton, United Kingdom, SO16 6YD
- Not yet recruiting
- Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
-
Contact:
- James Byrne
-
Taunton, United Kingdom, TA1 5DA
- Not yet recruiting
- Musgrove Park Hospital, Somerset Foundation NHS Trust
-
Contact:
- Richard Welbourn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Please note that participants need to be invited in order to take part in the trial.
Inclusion Criteria:
- Aged 18 to 60 years (inclusive) at time of screening.
Eligible for and willing to undergo bariatric surgery, i.e., fulfilment of criteria for bariatric surgery from the respective national health authorities:
- DK: BMI ≥ 35 kg/m2 with one or more of the following: T2D, severe hypertension, sleep apnoea requiring treatment, symptomatic arthrosis in lower extremities, female infertility related to overweight, or BMI>40 kg/m2 with other strong medical reasons for weight loss (28). Prior to surgery, an 8% weight loss is required as well as smoking cessation.
- UK: BMI of 35 kg/m2 to 40 kg/m2 and other significant disease (e.g., type 2 diabetes or high blood pressure), or BMI ≥40 kg/m2. Has been or is willing to receive intensive management in a specialist tier 3 obesity service (29).
- Fit for anaesthesia and surgery.
- Informed consent.
Exclusion Criteria:
- Prior bariatric or hiatal surgery, not including intragastric balloons or duodenal-jejunal bypass sleeve (Endobarrier™ or similar) if the device has been removed >1 year before screening.
- Use of any WLM (including liraglutide and semaglutide for diabetes) within last 3 months.
- Conditions that contraindicate or complicate total diet replacement (including type 1 diabetes or other diabetes requiring basal bolus insulin therapy or insulin pump therapy (for Denmark) and any diabetes requiring insulin therapy (for UK), phenylketonuria, or other conditions requiring strict adherence to special diets).
- Conditions that contraindicate or complicate treatment with GLP-1 receptor analogues (including history of pancreatitis or known allergies).
- Conditions that contraindicate or complicate bariatric surgery (GI motility disorders, large abdominal wall hernia, large hiatus hernia (>5cm), Crohn's disease, liver cirrhosis, or other conditions preventing laparoscopic bariatric surgery e.g. multiple previous abdominal surgery).
- Conditions that contraindicate or complicate study adherence and bariatric surgery (mental disorder, unstable psychiatric disease, recent history of alcohol/medication abuse, cancer treatment within 5 years).
- Pregnant or planning pregnancy in the next two years or currently breast feeding.
- Not achieving a 5% weight loss within 12 weeks prior to randomisation.
- People taking part in other research involving multidisciplinary obesity treatment that would compromise their participation in this trial.
- Another member of the household enrolled in the trial.
- Diagnosis of or treatment for severe eating disorder within the last 6 months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intensive weight loss intervention
The intensive weight loss intervention (IWL) includes total dietary replacements, behavioural support, and weight loss medication.
The intervention consists of three phases: induction, weight loss continuation, maintenance, and it will lasts two years in total.
|
Intensive weight loss intervention, incl.
total meal replacements, behavioural support, and weight loss medication
|
Active Comparator: Bariatric surgery
Bariatric surgery: Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
|
Roux-en-Y Gastric Bypass (RYGB) or Sleeve Gastrectomy (SG)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MetS-Z
Time Frame: 104 weeks after randomisation
|
Metabolic syndrome severity Z-score
|
104 weeks after randomisation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 104 weeks after randomisation
|
Weight (kg)
|
104 weeks after randomisation
|
Gait speed
Time Frame: 104 weeks after randomisation
|
4-metre gait speed (m/s)
|
104 weeks after randomisation
|
Short-Form-36, mental component score
Time Frame: 104 weeks after randomisation
|
Quality of life, SF36-mental component score (scale from 0-100, higher scores indicate better mental health)
|
104 weeks after randomisation
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SAE
Time Frame: 104 weeks after randomisation
|
Proportion of participants with at least one serious adverse event (according to ICH-GCP guidelines)
|
104 weeks after randomisation
|
Proportion of participants with at least one adverse events (AE) of special interest. Each of the AE will also be assessed individually exploratorily.
Time Frame: 104 weeks after randomisation
|
|
104 weeks after randomisation
|
Cardiometabolic health - metabolic syndrome
Time Frame: 104 weeks after randomisation
|
Proportion of participants with metabolic syndrome
|
104 weeks after randomisation
|
Cardiometabolic health - blood pressure
Time Frame: 104 weeks after randomisation
|
Systolic and diastolic blood pressure (mmHg)
|
104 weeks after randomisation
|
Cardiometabolic health - pulse
Time Frame: 104 weeks after randomisation
|
Pulse rate (beats per minute)
|
104 weeks after randomisation
|
Cardiometabolic health - glucose
Time Frame: 104 weeks after randomisation
|
Fasting glucose concentration (mmol/l)
|
104 weeks after randomisation
|
Cardiometabolic health - Hb1Ac
Time Frame: 104 weeks after randomisation
|
Haemoglobin A1c (mmol/mol)
|
104 weeks after randomisation
|
Cardiometabolic health - insulin
Time Frame: 104 weeks after randomisation
|
Fasting insulin concentration (pmol/L)
|
104 weeks after randomisation
|
Cardiometabolic health - HOMA2-IR
Time Frame: 104 weeks after randomisation
|
HOMA2-IR (calculated from glucose and C-peptide concentration) (ratio)
|
104 weeks after randomisation
|
Cardiometabolic health - lipids
Time Frame: 104 weeks after randomisation
|
Fasting lipid profile (HDL, LDL and triglycerides) (mmol/L)
|
104 weeks after randomisation
|
Cardiometabolic health - eGFR
Time Frame: 104 weeks after randomisation
|
Estimated Glomerular Filtration Rate (eGFR), creatinine (µmol/L), calculated from creatinine, sex and years
|
104 weeks after randomisation
|
Cardiometabolic health - hsCRP
Time Frame: 104 weeks after randomisation
|
High-sensitivity C-reactive protein (hsCRP), mg/L
|
104 weeks after randomisation
|
Cardiometabolic health - Fib-4
Time Frame: 104 weeks after randomisation
|
Fib-4 (ALT/AST/platelets) (ratio)
|
104 weeks after randomisation
|
Cardiometabolic health - proteinuria
Time Frame: 104 weeks after randomisation
|
Proteinuria, measured as urine albumin/creatinine (ratio)
|
104 weeks after randomisation
|
Cardiometabolic health - TSH
Time Frame: 104 weeks after randomisation
|
Thyroid-stimulating hormone (IU/L)
|
104 weeks after randomisation
|
Weight and body composition - weight loss
Time Frame: 104 weeks after randomisation
|
Proportion of participants with body weight loss of ≥20% and ≥15%
|
104 weeks after randomisation
|
Weight and body composition - waist circumference
Time Frame: 104 weeks after randomisation
|
Waist circumference (cm)
|
104 weeks after randomisation
|
Weight and body composition - body fat and lean body mass
Time Frame: 104 weeks after randomisation
|
Body fat (%) and lean body mass (%) assessed by DXA
|
104 weeks after randomisation
|
Physical functioning - sit to stand test
Time Frame: 104 weeks after randomisation
|
Number of sit to stands completed 30 Second Sit to Stand test
|
104 weeks after randomisation
|
Medication use
Time Frame: 104 weeks after randomisation
|
|
104 weeks after randomisation
|
Micronutrient status, assessed as proportion of participants with deficiency
Time Frame: During follow-up until 104 weeks after randomisation
|
|
During follow-up until 104 weeks after randomisation
|
Bone mineral density (BMD) assessed by DXA
Time Frame: 104 weeks after randomisation
|
|
104 weeks after randomisation
|
Sleep - ESS
Time Frame: 104 weeks after randomisation
|
Epworth Sleepiness Scale Questionnaire Score (scale from 0-24, higher scores indicate more sleepiness)
|
104 weeks after randomisation
|
Sleep - sleep and wake time
Time Frame: 104 weeks after randomisation
|
Estimated sleep and wake time (minutes/day)
|
104 weeks after randomisation
|
Sleep - sleep movement
Time Frame: 104 weeks after randomisation
|
Movement during sleep estimated by SENS.
|
104 weeks after randomisation
|
Health-related quality of life and mental health - EQ-5D-5L, index score
Time Frame: 104 weeks after randomisation
|
EQ-5D-5L, index score (score between -1 and 1, higher scores indicate better health)
|
104 weeks after randomisation
|
Health-related quality of life and mental health - EQ-5D-5L, VAS
Time Frame: 104 weeks after randomisation
|
EQ-5D-5L, VAS score (scale from 0-100, higher scores indicate better health)
|
104 weeks after randomisation
|
Health-related quality of life and mental health - SF-36
Time Frame: 104 weeks after randomisation
|
Short-Form-36, physical component score (scale from 0-100, higher scores indicate better physical health)
|
104 weeks after randomisation
|
Health-related quality of life and mental health - EDE-Q
Time Frame: 104 weeks after randomisation
|
Eating Disorder Examination Questionnaire (EDE-Q) score (scale from 0 to 6, higher scores indicate higher degree of eating disorder)
|
104 weeks after randomisation
|
Health-related quality of life and mental health - WBIS-M
Time Frame: 104 weeks after randomisation
|
Weight Bias Internalization Scale (WBIS-M) score (scale from 1-7, higher scores indicate higher degree of internalised weight bias)
|
104 weeks after randomisation
|
Health-related quality of life and mental health - MDI
Time Frame: 104 weeks after randomisation
|
Major Depression Inventory (MDI) (scale from 0-50, higher scores indicate more symptoms of depression)
|
104 weeks after randomisation
|
Labour market attachment - WPAI
Time Frame: 104 weeks after randomisation
|
Work productivity and impairment (WPAI) score points (scale from 0-100, higher scores indicate more limitations in ability to work and lower productivity)
|
104 weeks after randomisation
|
Labour market attachment - days of sick leave
Time Frame: 104 weeks after randomisation
|
Self-reported number of days sick leave during follow-up
|
104 weeks after randomisation
|
Continuous glucose monitoring - hypoglycaemic range
Time Frame: 104 weeks after randomisation:
|
Time spent in level 1 hypoglycaemic range (interstitial fluid glucose (IFG) <3.9 mmol/L)
|
104 weeks after randomisation:
|
Continuous glucose monitoring - hypoglycaemic events
Time Frame: 104 weeks after randomisation:
|
Number of hypoglycaemic events (15 minutes of IFG<3 mmol/L)
|
104 weeks after randomisation:
|
Continuous glucose monitoring - glucose variability
Time Frame: 104 weeks after randomisation:
|
Glucose variability (CV)
|
104 weeks after randomisation:
|
Continuous glucose monitoring - hypoglycaemic symptoms
Time Frame: 104 weeks after randomisation:
|
Self-reported hypoglycaemic symptoms as recorded in hypoglycaemic symptom diary (reported descriptively)
|
104 weeks after randomisation:
|
Pending additional funding: Genetic profiles' (using comprehensive genetic mapping) association with the metabolic and/or weight loss response to IWL vs bariatric surgery
Time Frame: 104 weeks after randomisation
|
|
104 weeks after randomisation
|
Health economy: Within-trial cost-effectiveness analysis - quality of life
Time Frame: 104 weeks after randomisation
|
Quality of life (measured using EQ-5D-5L)
|
104 weeks after randomisation
|
Health economy: Within-trial cost-effectiveness analysis - costs
Time Frame: 104 weeks after randomisation
|
24-month costs, DKK
|
104 weeks after randomisation
|
Health economy: Within-trial cost-effectiveness analysis - QALY
Time Frame: 104 weeks after randomisation
|
Incremental cost per quality-adjusted-life-year (QALY) gained, DKK
|
104 weeks after randomisation
|
Health economy: Model-based cost-effectiveness analysis - QALY
Time Frame: 104 weeks after randomisation
|
Predicted lifetime QALYs gained
|
104 weeks after randomisation
|
Health economy: Model-based cost-effectiveness analysis - healthcare costs
Time Frame: 104 weeks after randomisation
|
Predicted lifetime healthcare costs, DKK
|
104 weeks after randomisation
|
Health economy: Model-based cost-effectiveness analysis - cost effectiveness ratios
Time Frame: 104 weeks after randomisation
|
Long-term incremental cost effectiveness ratios
|
104 weeks after randomisation
|
Long-term effects - mortality and major cardiovascular disease (CVD)
Time Frame: 5, 10 and 20 years after randomisation
|
|
5, 10 and 20 years after randomisation
|
Long-term effects - prescription patterns
Time Frame: 5, 10 and 20 years after randomisation
|
|
5, 10 and 20 years after randomisation
|
Long-term effect - incident cancer
Time Frame: 5, 10 and 20 years after randomisation
|
|
5, 10 and 20 years after randomisation
|
Long-term effect - surgical procedures
Time Frame: 5, 10 and 20 years after randomisation
|
|
5, 10 and 20 years after randomisation
|
Long-term effect - fracture risk
Time Frame: 5, 10 and 20 years after randomisation
|
|
5, 10 and 20 years after randomisation
|
Long-term effect - health economic and labour market attachment, employment status
Time Frame: 5, 10 and 20 years after randomisation
|
Employment status each participant
|
5, 10 and 20 years after randomisation
|
Long-term effect - health economic and labour market attachment, salary
Time Frame: 5, 10 and 20 years after randomisation
|
Salary for each participant
|
5, 10 and 20 years after randomisation
|
Long-term effect - health economic and labour market attachment, absence
Time Frame: 5, 10 and 20 years after randomisation
|
Number of absence days
|
5, 10 and 20 years after randomisation
|
Long-term effect - health economic and labour market attachment, sick leave
Time Frame: 5, 10 and 20 years after randomisation
|
Proportion of participants with any sick leave
|
5, 10 and 20 years after randomisation
|
Long-term effect - health economic and labour market attachment, long-term sick leave
Time Frame: 5, 10 and 20 years after randomisation
|
Proportion of participants with long-term sick leave (more than 4 weeks continuous sickness absence)
|
5, 10 and 20 years after randomisation
|
Physical functioning - sedentary and active
Time Frame: 104 weeks after randomisation
|
Time spent sedentary and active (moderate to vigorous physical activity) estimated by SENS activity tracker (minutes/day)
|
104 weeks after randomisation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Carsten Dirksen, Ass Professor, Department of Medicine, Copenhagen University Hospital - Amager and Hvidovre
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LightBAR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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