Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Any actual medical condition except for obesity related health issues or well treated hypothyroidism
Pregnancy anticipated in the first two years following surgery
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
Trial population
Patients of the Nederlandse Obesitas Kliniek (Dutch Obesity Clinic).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Predictors of improvement in metabolic health - insulin sensitivity
HOMA-IR
Time frame
Baseline up to 5 years after surgery2
Predictors of improvement in metabolic health - level of glucose control
HbA1C (mmol/mol)
Time frame
Baseline up to 5 years after surgery3
Predictors of improvement in metabolic health - glucose
Fasting glucose (mmol/L)
Time frame
Baseline up to 5 years after surgery4
Predictors of improvement in metabolic health - insulin
Insulin (pmol/L)
Time frame
Baseline up to 5 years after surgerySecondary outcomes
1
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
Time frame
Baseline up to 5 years after surgery2
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.
Time frame
Baseline up to 5 years after surgery3
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.
Time frame
Baseline up to 5 years after surgery4
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
Time frame
Baseline up to 5 years after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead sponsor
Obesitas Kliniek B.V.
Collaborator
Radboud University Medical Center
Collaborator
Source ClinicalTrials.gov