Predictors of Weight Loss and Metabolic Health After Bariatric Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Obesity, Morbid; Bariatric Surgery Candidate; Insulin Sensitivity; Feeding Behavior

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 Type: Observational
• Enrollment (Estimated): 1200

Contacts and Locations

• Study Contact: Name: Rieneke van der Meer, Drs.; Phone Number: +31703204703; Email: r.vandermeer1@amsterdamumc.nl
• Study Contact Backup: Name: Lianda CH Luiijpers, Drs.; Email: lianda.luijpers@radboudumc.nl

Study Locations

• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3431HK
      • Not yet recruiting
      • Nederlandse Obesitas Kliniek Nieuwegein
      • Contact: Lianda Luijpers, Drs.; Email: lianda.luijpers@radboudumc.nl
  • Zuid-Holland
    • Den Haag, Zuid-Holland, Netherlands, 2591XR
      • Recruiting
      • Nederlandse Obesitas Kliniek Den Haag
      • Contact: Rieneke van der Meer, Drs.; Phone Number: +31703204703; Email: rvandermeer@obesitaskliniek.nl
    • Gouda, Zuid-Holland, Netherlands, 2803PW
      • Not yet recruiting
      • Nederlandse Obesitas Kliniek Gouda
      • Contact: Rieneke van der Meer, Drs.; Phone Number: +31182232040; Email: rvandermeer@obesitaskliniek.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients of the Nederlandse Obesitas Kliniek (Dutch Obesity Clinic).

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of improvement in metabolic health - insulin sensitivity	HOMA-IR	Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - level of glucose control	HbA1C (mmol/mol)	Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - glucose	Fasting glucose (mmol/L)	Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - insulin	Insulin (pmol/L)	Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - lipid profile	Lipids (mmol/L)	Baseline up to 5 years after surgery
Predictors of improvement in metabolic health - biomarker inflammation	CRP (mg/L)	Baseline up to 5 years after surgery
Predictors of improvement in metabolic health	Genetic variants using GWAS analysis	Baseline up to 5 years after surgery
Predictors of weight loss	Genetic variants using GWAS analysis	Baseline up to 5 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: Radboud University Medical Center; Obesitas Kliniek B.V.
• Investigators: Principal Investigator: Mireille JM Serlie, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Principal Investigator: Valerie M Monpellier, Dr., Obesitas Nederland B.V.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Weight loss; Bariatric Surgery; Metabolic health; Predictors
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Hyperinsulinism; Body Weight Changes; Obesity; Weight Loss; Insulin Resistance; Obesity, Morbid
• Other Study ID Numbers: 2021_136; NL77692.018.21 (Other Identifier: Amsterdam UMC); NTR9447 (Registry Identifier: Nederlands Trial Register)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No