Predictors of Weight Loss and Metabolic Health After Bariatric Surgery

NCT05987631 | Recruiting DMC

• 3 other identifiers: 2021_136NL77692.018.21NTR9447
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 3

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

Conditions

Obesity, Morbid; Insulin Sensitivity; Bariatric Surgery Candidate; Feeding Behavior

Keywords

Obesity; Bariatric Surgery; Metabolic health; Weight loss; Predictors

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (18)

• Psychological factors - depression

  Baseline up to 5 years after surgery

• Psychological factors - anxiety

  Baseline up to 5 years after surgery

• Psychological factors - impulsivity

  Baseline up to 5 years after surgery

• Psychological factors - impulsivity

  Baseline up to 5 years after surgery

• Predictors of weight loss - food addiction

  Baseline up to 5 years after surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Obesitas Kliniek B.V.: collaborator
• Radboud University Medical Center: collaborator

Study Sites (3)

Nederlandse Obesitas Kliniek Gouda

Gouda, South Holland, 2803PW, Netherlands

NOT YET RECRUITING

Nederlandse Obesitas Kliniek Den Haag

The Hague, South Holland, 2591XR, Netherlands

RECRUITING

Nederlandse Obesitas Kliniek Nieuwegein

Nieuwegein, Utrecht, 3431HK, Netherlands

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and tissue (fat, muscle, liver)

MeSH Terms

Conditions

Obesity, Morbid; Insulin Resistance; Feeding Behavior; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Behavior, Animal; Behavior; Body Weight Changes

Study Officials

• Mireille JM Serlie, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

• Valerie M Monpellier, Dr.

  Obesitas Nederland B.V.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rieneke van der Meer, Drs.

CONTACT

+31703204703; r.vandermeer1@amsterdamumc.nl

Lianda CH Luiijpers, Drs.

CONTACT

lianda.luijpers@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Mireille JM Serlie

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: August 14, 2023
• Study Start: January 19, 2023
• Primary Completion: August 31, 2024
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

NL (3)