Obesity, MorbidNCT05987631
Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
An observational study of Obesity, Morbid and Insulin Sensitivity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
Trial summary
In this prospective study the investigators aim to identify preoperative predictors of improvement of metabolic health and weight loss after bariatric surgery focusing on inflammation, insulin sensitivity (in a subgroup of patients), glucoregulatory determinants, psychological traits, feeding behavior characteristics… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Morbid, Insulin Sensitivity, Bariatric Surgery Candidate
- How many people
- 1,200 participants
- Where
- 3 sitesNetherlands
- Study dates
- 19 Jan 2023to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of the Nederlandse Obesitas Kliniek (Dutch Obesity Clinic).
Who may be able to join
- Ability to provide informed consent
- Patient is ≥ 18 and ≤ 75 years old
- BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with obesity related comorbidity
- Scheduled for primary bariatric procedure: Roux-en-Y gastric bypass (RYGB) or Sleeve Gastrectomy (SG)
- Stable weight 3 months prior to inclusion weight (<10% change in body weight for 3 months prior to assessments)
- In order to be eligible to participate in the subgroup of this study, we will use the following inclusion criteria:
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- Ability to provide informed consent
- Patient is ≥ 18 and ≤ 75 years old
- BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with obesity related comorbidity
- Patients scheduled for RYGB
- Patients who are insulin resistant (impaired fasting glucose (> 5.6 mmol/L) or fasting insulin > 74 pmol/L)
- Postmenopausal women (to prevent bias due to the effect of sex hormones on insulin sensitivity)
Who cannot join
- Any actual medical condition except for obesity related health issues or well treated hypothyroidism
- Pregnancy anticipated in the first two years following surgery
- A potential subject who meet the following criteria will be excluded from participation in the subgroup of this study:
- Coagulation disorders and/or use anticoagulants
- Use of any medication except for statins, antihypertensives (except for Angiotensine converting enzyme (ACE)- or angiotensin receptor blockers) and thyroid hormone
- Diabetes mellitus type 2
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lianda CH Luiijpers, Drs. contact
Netherlands3 sites, 3 recruiting
- Not yet recruiting
Nederlandse Obesitas Kliniek Gouda
Gouda, South Holland, 2803PW
Rieneke van der Meer, Drs., +31182232040, rvandermeer@obesitaskliniek.nl
- Not yet recruiting
Nederlandse Obesitas Kliniek Nieuwegein
Nieuwegein, Utrecht, 3431HK
Lianda Luijpers, Drs., lianda.luijpers@radboudumc.nl
- Recruiting
Nederlandse Obesitas Kliniek Den Haag
The Hague, South Holland, 2591XR
Rieneke van der Meer, Drs., +31703204703, rvandermeer@obesitaskliniek.nl
About this study
Official title: Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery
In this prospective study the investigators aim to identify preoperative predictors of improvement of metabolic health and weight loss after bariatric surgery focusing on inflammation, insulin sensitivity (in a subgroup of patients), glucoregulatory determinants, psychological traits, feeding behavior characteristics and cardiorespiratory fitness
Read the detailed description
Obesity is the result of a complex interplay between genetic and epigenetic predisposition, environment, physical activity, nutrition and psychology. It is a debilitating disorder and a risk factor for the development of metabolic disorders such as dyslipidaemia, hypertension and hyperglycaemia as well as certain cancers. Bariatric surgery has proven to be the most effective treatment for morbid obesity with established long-term results of weight loss, remission of comorbid conditions and the improvement of Quality of Life (QoL). However, variability in these results after bariatric surgery is well known. Identifying preoperative predictors of postoperative weight loss and metabolic health is of clinical priority. Predictors could help further improve the efficacy of care for obesity by tailoring treatment to the individual, based on their predicted response and therefore optimize outcome after bariatric surgery.
- Keywords
- Obesity, Bariatric Surgery, Metabolic health, Weight loss, Predictors
- Medical subject headings
- Obesity, Morbid, Insulin Resistance, Feeding Behavior, Obesity, Weight Loss
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictors of improvement in metabolic health - insulin sensitivity
HOMA-IR
Measured: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - level of glucose control
HbA1C (mmol/mol)
Measured: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - glucose
Fasting glucose (mmol/L)
Measured: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - insulin
Insulin (pmol/L)
Measured: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - lipid profile
Lipids (mmol/L)
Measured: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - biomarker inflammation
CRP (mg/L)
Measured: Baseline up to 5 years after surgery
Predictors of improvement in metabolic health
Genetic variants using GWAS analysis
Measured: Baseline up to 5 years after surgery
Predictors of weight loss
Genetic variants using GWAS analysis
Measured: Baseline up to 5 years after surgery
Secondary outcomes (18)
Psychological factors - depression
Patient-Reported Outcomes Measurement Information System Depression (PROMIS-D: validated questionnaire for bariatric surgery. PROMIS-D: range in score from 8 to 40, higher scores indicating greater severity of depression
Measured: Baseline up to 5 years after surgery
Psychological factors - anxiety
Patient-Reported Outcomes Measurement Information System Anxiety (PROMIS-A): validated questionnaire for bariatric surgery. PROMIS-A: range in score from 7 to 35, higher scores indicating greater severity of anxiety.
Measured: Baseline up to 5 years after surgery
Psychological factors - impulsivity
Measurements of impulsiveness Barret Impulsiveness Scale (BIS): validated questionnaire to assess level of impulsivity
BIS-11: The total scores can range from 30 to 120. Higher scores on the BIS reflect higher levels of impulsiveness.
Measured: Baseline up to 5 years after surgery
Psychological factors - impulsivity
Measurements of impulsiveness Iowa Gambling Task: validated task to study impulsive behaviour
Iowa gambling task: The net score is calculated by subtracting the number of disadvantageous selections from the advantageous selections. A positive net score indicates better performance
Measured: Baseline up to 5 years after surgery
Predictors of weight loss - food addiction
Food addiction scale (YFAS 2.0): validated questionnaire to assess food addiction.
YFAS 2.0 includes two scoring methods, a continuous symptom count and a diagnosis of food addiction.
Continious symptom count ranges from zero to eleven, Diagnosis of food addiction: no food addiction (0-1 symptoms), a mild food addicition (2-3 symptoms), a moderate food addiction (4-5 symptoms), or a severe food addiction (>6 symptoms).
Measured: Baseline up to 5 years after surgery
Predictors of weight loss - eating behaviour
Dutch Eating Behaviour Questionnaire (DEBQ): validated questionnaire to assess eating behaviour.
DEBQ consists of 33 items.Items on the DEBQ range from 1 (never) to 5 (very often), with higher scores indicating greater endorsement of the eating behavior.
Measured: Baseline up to 5 years after surgery
Predictors of weight loss - Quality of Life
Selfesteem scale of Impact of Weight on Quality of Life - lite (IWQOL-lite): validated questionnaire after weight loss interventions. The self-esteem scale consists of 7 items. Each item is rated on a 5-point scale. Higher scores represent better quality of life.
Measured: Baseline up to 5 years after surgery
Predictors of weight loss - Quality of Life
OBESI-Q (Obesity): validated questionnaire for reporting Health Related Quality of Life. Outcome is expressed on a 100 point scale, a higher score is higher quality of life, with the exception of item "Excess skin".
Measured: Baseline up to 5 years after surgery
Predictors of weight loss - Quality of Life
EuroQuality of Life (EQ-5D): validated questionnaire for reporting Quality of Life after bariatric surgery. Each item is rated on a 5-point scale. Higher scores represent lower reported quality of life.
Measured: Baseline up to 5 years after surgery
Predictors of weight loss - Impulsivity
Measurements of impulsiveness Barret Impulsiveness Scale (BIS): validated questionnaire to assess level of impulsivity
BIS-11: The total scores can range from 30 to 120. Higher scores on the BIS reflect higher levels of impulsiveness.
Measured: Baseline up to 5 years after surgery
Predictors of weight loss - Impulsivity
Measurements of impulsiveness Iowa Gambling Task: validated task to study impulsive behaviour
Iowa gambling task: The net score is calculated by subtracting the number of disadvantageous selections from the advantageous selections. A positive net score indicates better performance
Measured: Baseline up to 5 years after surgery
Predictors of weight loss - Physical activity
Short Questionnaire to Assess Health Enhancing Physical Activity (SQUASH): validated questionnaire to assess physical activity.
The SQUASH measures the frequency, duration and intensity of 5 different physical activities: commuting (traveling to and from work/study), housekeeping , activities at work, leisure time, and sports. A higher score = more time spend on physical activities.
Measured: Baseline up to 5 years after surgery
Sexual dimorphism in weight loss
Males versus females regarding weight loss (kg) and percentage of total weight loss
Measured: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - insulin sensitivity
Males versus females regarding insulin sensitivity (HOMA-IR) and measurements of glucose and insuline
Measured: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - improvement of diabetes
Males versus females regarding HbA1c values and diabetic drug use
Measured: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - lipid
Males versus females regarding lipids (mmol/L) and lipid-lowering agents use
Measured: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - hypertension
Males versus females regarding blood pressure (mmHg) and anithypertensive medication use
Measured: Baseline up to 5 years after surgery
Peripheral insulin sensitivity
In a subset of 40 patients insulin sensitivity will be assessed using hyperinsulinemic euglycemic clamps, and adipose tissue and skeletal muscle biopsies will be taken to assess insulin signalling (expression of mRNA and phosphorylated proteins)
Measured: Before and 3 and 18 months after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start19 Jan 2023
- Primary completion31 Aug 2024 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Obesitas Kliniek B.V., Radboud University Medical Center
- Responsible party
- Principal investigator, Prof. Dr. Mireille JM Serlie, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Mireille JM Serlie, Prof. Dr., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Valerie M Monpellier, Dr., Principal investigator, Obesitas Nederland B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987631
- Sponsor's protocol ID
- 2021_136
- Other IDs
- NL77692.018.21, NTR9447
- Status last verified
- Aug 2023
- First submitted
- 21 Apr 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT05987631
- Acronym / sponsor ID
- 2021_136
- Keywords
- Obesity, Bariatric Surgery, Metabolic health, Weight loss, Predictors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Obesitas Kliniek B.V., Radboud University Medical Center
- Study start
- 19 Jan 2023 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this prospective study the investigators aim to identify preoperative predictors of improvement of metabolic health and weight loss after bariatric surgery focusing on inflammation, insulin sensitivity (in a subgroup of patients), glucoregulatory determinants, psychological traits, feeding behavior characteristics and cardiorespiratory fitness
Detailed description
Obesity is the result of a complex interplay between genetic and epigenetic predisposition, environment, physical activity, nutrition and psychology. It is a debilitating disorder and a risk factor for the development of metabolic disorders such as dyslipidaemia, hypertension and hyperglycaemia as well as certain cancers. Bariatric surgery has proven to be the most effective treatment for morbid obesity with established long-term results of weight loss, remission of comorbid conditions and the improvement of Quality of Life (QoL). However, variability in these results after bariatric surgery is well known. Identifying preoperative predictors of postoperative weight loss and metabolic health is of clinical priority. Predictors could help further improve the efficacy of care for obesity by tailoring treatment to the individual, based on their predicted response and therefore optimize outcome after bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Nederlandse Obesitas Kliniek (Dutch Obesity Clinic).
Key inclusion criteria (12 listed)
- Ability to provide informed consent
- Patient is ≥ 18 and ≤ 75 years old
- BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with obesity related comorbidity
- Scheduled for primary bariatric procedure: Roux-en-Y gastric bypass (RYGB) or Sleeve Gastrectomy (SG)
- Stable weight 3 months prior to inclusion weight (<10% change in body weight for 3 months prior to assessments)
Key exclusion criteria (6 listed)
- Any actual medical condition except for obesity related health issues or well treated hypothyroidism
- Pregnancy anticipated in the first two years following surgery
- A potential subject who meet the following criteria will be excluded from participation in the subgroup of this study:
- Coagulation disorders and/or use anticoagulants
- Use of any medication except for statins, antihypertensives (except for Angiotensine converting enzyme (ACE)- or angiotensin receptor blockers) and thyroid hormone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictors of improvement in metabolic health - insulin sensitivity
Time frame: Baseline up to 5 years after surgery
HOMA-IR
Predictors of improvement in metabolic health - level of glucose control
Time frame: Baseline up to 5 years after surgery
HbA1C (mmol/mol)
Predictors of improvement in metabolic health - glucose
Time frame: Baseline up to 5 years after surgery
Fasting glucose (mmol/L)
Predictors of improvement in metabolic health - insulin
Time frame: Baseline up to 5 years after surgery
Insulin (pmol/L)
Predictors of improvement in metabolic health - lipid profile
Time frame: Baseline up to 5 years after surgery
Lipids (mmol/L)
Predictors of improvement in metabolic health - biomarker inflammation
Time frame: Baseline up to 5 years after surgery
CRP (mg/L)
Predictors of improvement in metabolic health
Time frame: Baseline up to 5 years after surgery
Genetic variants using GWAS analysis
Predictors of weight loss
Time frame: Baseline up to 5 years after surgery
Genetic variants using GWAS analysis
18 secondary outcomes
Psychological factors - depression
Time frame: Baseline up to 5 years after surgery
Psychological factors - anxiety
Time frame: Baseline up to 5 years after surgery
Psychological factors - impulsivity
Time frame: Baseline up to 5 years after surgery
Psychological factors - impulsivity
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - food addiction
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - eating behaviour
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Quality of Life
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Quality of Life
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Quality of Life
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Impulsivity
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Impulsivity
Time frame: Baseline up to 5 years after surgery
Predictors of weight loss - Physical activity
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in weight loss
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - insulin sensitivity
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - improvement of diabetes
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - lipid
Time frame: Baseline up to 5 years after surgery
Sexual dimorphism in restoration of metabolic health - hypertension
Time frame: Baseline up to 5 years after surgery
Peripheral insulin sensitivity
Time frame: Before and 3 and 18 months after bariatric surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lianda CH Luiijpers, Drs. contact
Mireille JM Serlie, Prof. Dr. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Valerie M Monpellier, Dr. principal investigator
Obesitas Nederland B.V.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Insulin Sensitivity, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rieneke van der Meer, Drs. (+31703204703, r.vandermeer1@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of improvement in metabolic health - insulin sensitivity (time frame: Baseline up to 5 years after surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.