Clinical trial NCT05987631: Predictors of Weight Loss and Metabolic Health After Bariatric Surgery
Official title: Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Insulin Sensitivity
Bariatric Surgery Candidate
Feeding Behavior
Keywords: Obesity
Bariatric Surgery
Metabolic health
Weight loss
Predictors
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Obesitas Kliniek B.V.
name: Radboud University Medical Center
First posted: 2023-08-14
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of the Nederlandse Obesitas Kliniek (Dutch Obesity Clinic).

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predictors of improvement in metabolic health - insulin sensitivity
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of improvement in metabolic health - level of glucose control
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of improvement in metabolic health - glucose
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of improvement in metabolic health - insulin
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of improvement in metabolic health - lipid profile
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of improvement in metabolic health - biomarker inflammation
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of improvement in metabolic health
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of weight loss
timeFrame: Baseline up to 5 years after surgery
Secondary outcomes:
measure: Psychological factors - depression
timeFrame: Baseline up to 5 years after surgery
measure: Psychological factors - anxiety
timeFrame: Baseline up to 5 years after surgery
measure: Psychological factors - impulsivity
timeFrame: Baseline up to 5 years after surgery
measure: Psychological factors - impulsivity
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of weight loss - food addiction
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of weight loss - eating behaviour
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of weight loss - Quality of Life
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of weight loss - Quality of Life
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of weight loss - Quality of Life
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of weight loss - Impulsivity
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of weight loss - Impulsivity
timeFrame: Baseline up to 5 years after surgery
measure: Predictors of weight loss - Physical activity
timeFrame: Baseline up to 5 years after surgery
measure: Sexual dimorphism in weight loss
timeFrame: Baseline up to 5 years after surgery
measure: Sexual dimorphism in restoration of metabolic health - insulin sensitivity
timeFrame: Baseline up to 5 years after surgery
measure: Sexual dimorphism in restoration of metabolic health - improvement of diabetes
timeFrame: Baseline up to 5 years after surgery
measure: Sexual dimorphism in restoration of metabolic health - lipid
timeFrame: Baseline up to 5 years after surgery
measure: Sexual dimorphism in restoration of metabolic health - hypertension
timeFrame: Baseline up to 5 years after surgery
measure: Peripheral insulin sensitivity
timeFrame: Before and 3 and 18 months after bariatric surgery
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: Nederlandse Obesitas Kliniek Nieuwegein
state: Utrecht
city: Den Haag
country: Netherlands
facility: Nederlandse Obesitas Kliniek Den Haag
state: Zuid-Holland
city: Gouda
country: Netherlands
facility: Nederlandse Obesitas Kliniek Gouda
state: Zuid-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Mireille JM Serlie, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Obesitas Nederland B.V.
name: Valerie M Monpellier, Dr.
role: PRINCIPAL_INVESTIGATOR
References: