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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05987631
Other study ID # 2021_136
Secondary ID NL77692.018.21NT
Status Recruiting
Phase
First received
Last updated
Start date January 19, 2023
Est. completion date August 31, 2027

Study information

Verified date August 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Rieneke van der Meer, Drs.
Phone +31703204703
Email r.vandermeer1@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 and cardiorespiratory fitness


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1200
Est. completion date August 31, 2027
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - 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: - 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) Exclusion Criteria: - 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

Study Design


Locations

Country Name City State
Netherlands Nederlandse Obesitas Kliniek Den Haag Den Haag Zuid-Holland
Netherlands Nederlandse Obesitas Kliniek Gouda Gouda Zuid-Holland
Netherlands Nederlandse Obesitas Kliniek Nieuwegein Nieuwegein Utrecht

Sponsors (3)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Obesitas Kliniek B.V., Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Predictors of improvement in metabolic health - insulin sensitivity HOMA-IR Baseline up to 5 years after surgery
Primary Predictors of improvement in metabolic health - level of glucose control HbA1C (mmol/mol) Baseline up to 5 years after surgery
Primary Predictors of improvement in metabolic health - glucose Fasting glucose (mmol/L) Baseline up to 5 years after surgery
Primary Predictors of improvement in metabolic health - insulin Insulin (pmol/L) Baseline up to 5 years after surgery
Primary Predictors of improvement in metabolic health - lipid profile Lipids (mmol/L) Baseline up to 5 years after surgery
Primary Predictors of improvement in metabolic health - biomarker inflammation CRP (mg/L) Baseline up to 5 years after surgery
Primary Predictors of improvement in metabolic health Genetic variants using GWAS analysis Baseline up to 5 years after surgery
Primary Predictors of weight loss Genetic variants using GWAS analysis Baseline up to 5 years after surgery
Secondary 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 Baseline up to 5 years after surgery
Secondary 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. Baseline up to 5 years after surgery
Secondary 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.
Baseline up to 5 years after surgery
Secondary 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
Baseline up to 5 years after surgery
Secondary 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).
Baseline up to 5 years after surgery
Secondary 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.
Baseline up to 5 years after surgery
Secondary 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. Baseline up to 5 years after surgery
Secondary 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". Baseline up to 5 years after surgery
Secondary 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. Baseline up to 5 years after surgery
Secondary 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.
Baseline up to 5 years after surgery
Secondary 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
Baseline up to 5 years after surgery
Secondary 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.
Baseline up to 5 years after surgery
Secondary Sexual dimorphism in weight loss Males versus females regarding weight loss (kg) and percentage of total weight loss Baseline up to 5 years after surgery
Secondary Sexual dimorphism in restoration of metabolic health - insulin sensitivity Males versus females regarding insulin sensitivity (HOMA-IR) and measurements of glucose and insuline Baseline up to 5 years after surgery
Secondary Sexual dimorphism in restoration of metabolic health - improvement of diabetes Males versus females regarding HbA1c values and diabetic drug use Baseline up to 5 years after surgery
Secondary Sexual dimorphism in restoration of metabolic health - lipid Males versus females regarding lipids (mmol/L) and lipid-lowering agents use Baseline up to 5 years after surgery
Secondary Sexual dimorphism in restoration of metabolic health - hypertension Males versus females regarding blood pressure (mmHg) and anithypertensive medication use Baseline up to 5 years after surgery
Secondary 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) Before and 3 and 18 months after bariatric surgery
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