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NCT Number: NCT05987631

Predictors of Weight Loss and 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

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Key information

Conditions

Obesity, Morbid Bariatric Surgery Candidate Behavior Behavior, Animal Body Weight Body Weight Changes Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nederlandse Obesitas Kliniek Gouda, Gouda, South Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Predictors of improvement in metabolic health - insulin sensitivity

    Time frame: Baseline up to 5 years after surgery

    HOMA-IR

  2. Predictors of improvement in metabolic health - level of glucose control

    Time frame: Baseline up to 5 years after surgery

    HbA1C (mmol/mol)

  3. Predictors of improvement in metabolic health - glucose

    Time frame: Baseline up to 5 years after surgery

    Fasting glucose (mmol/L)

  4. Predictors of improvement in metabolic health - insulin

    Time frame: Baseline up to 5 years after surgery

    Insulin (pmol/L)

  5. Predictors of improvement in metabolic health - lipid profile

    Time frame: Baseline up to 5 years after surgery

    Lipids (mmol/L)

  6. Predictors of improvement in metabolic health - biomarker inflammation

    Time frame: Baseline up to 5 years after surgery

    CRP (mg/L)

  7. Predictors of improvement in metabolic health

    Time frame: Baseline up to 5 years after surgery

    Genetic variants using GWAS analysis

  8. Predictors of weight loss

    Time frame: Baseline up to 5 years after surgery

    Genetic variants using GWAS analysis

Secondary outcomes

  1. Psychological factors - depression

    Time frame: Baseline up to 5 years after surgery

    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

  2. Psychological factors - anxiety

    Time frame: Baseline up to 5 years after surgery

    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.

  3. Psychological factors - impulsivity

    Time frame: Baseline up to 5 years after surgery

    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.

  4. Psychological factors - impulsivity

    Time frame: Baseline up to 5 years after surgery

    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

  5. Predictors of weight loss - food addiction

    Time frame: Baseline up to 5 years after surgery

    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).

  6. Predictors of weight loss - eating behaviour

    Time frame: Baseline up to 5 years after surgery

    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.

  7. Predictors of weight loss - Quality of Life

    Time frame: Baseline up to 5 years after surgery

    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.

  8. Predictors of weight loss - Quality of Life

    Time frame: Baseline up to 5 years after surgery

    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".

  9. Predictors of weight loss - Quality of Life

    Time frame: Baseline up to 5 years after surgery

    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.

  10. Predictors of weight loss - Impulsivity

    Time frame: Baseline up to 5 years after surgery

    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.

  11. Predictors of weight loss - Impulsivity

    Time frame: Baseline up to 5 years after surgery

    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

  12. Predictors of weight loss - Physical activity

    Time frame: Baseline up to 5 years after surgery

    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.

  13. Sexual dimorphism in weight loss

    Time frame: Baseline up to 5 years after surgery

    Males versus females regarding weight loss (kg) and percentage of total weight loss

  14. Sexual dimorphism in restoration of metabolic health - insulin sensitivity

    Time frame: Baseline up to 5 years after surgery

    Males versus females regarding insulin sensitivity (HOMA-IR) and measurements of glucose and insuline

  15. Sexual dimorphism in restoration of metabolic health - improvement of diabetes

    Time frame: Baseline up to 5 years after surgery

    Males versus females regarding HbA1c values and diabetic drug use

  16. Sexual dimorphism in restoration of metabolic health - lipid

    Time frame: Baseline up to 5 years after surgery

    Males versus females regarding lipids (mmol/L) and lipid-lowering agents use

  17. Sexual dimorphism in restoration of metabolic health - hypertension

    Time frame: Baseline up to 5 years after surgery

    Males versus females regarding blood pressure (mmHg) and anithypertensive medication use

  18. Peripheral insulin sensitivity

    Time frame: Before and 3 and 18 months after bariatric surgery

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Lianda CH Luiijpers, Drs.

CONTACT

[email protected]

Rieneke van der Meer, Drs.

CONTACT

[email protected]

+31703204703

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • Obesitas Kliniek B.V.
  • Radboud University Medical Center

Registry information

Official study title

Preoperative Predictors of Weight Loss and Improved Metabolic Health After Bariatric Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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