Image

Predictors of Weight Loss and Metabolic Health After Bariatric Surgery

Predictors of Weight Loss and Metabolic Health After Bariatric Surgery

Recruiting
18-75 years
All
Phase N/A

Powered by AI

Overview

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

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

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 details
    Obesity
    Morbid
    Insulin Sensitivity
    Bariatric Surgery Candidate
    Feeding Behavior

NCT05987631

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

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.