Investigating the effects of fructose intake on insulin resistance in obese patients undergoing bariatric surgery

BaRiatric Surgery AnD FRUctose Handeling In Obese subjecTs

This study is testing how different amounts of fructose in the diet affect insulin resistance and weight loss in obese people getting gastric bypass surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Amsterdam)
• Trial ID: NCT05717595 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to explore how different levels of dietary fructose intake affect insulin resistance and weight loss outcomes in obese individuals scheduled for Roux-en-Y gastric bypass (RYGB) surgery. Participants, who are Caucasian males and premenopausal females aged 18 and older, will be randomly assigned to either a high fructose diet or a low fructose diet for four weeks prior to surgery. The study will measure changes in glucose and insulin levels following a fructose challenge, as well as analyze liver and gut microbiota changes through biopsies and fecal samples. The long-term impact on weight loss will also be assessed up to one year post-surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are Caucasian males and premenopausal women over 18 years old who are scheduled for RYGB surgery and meet specific obesity criteria.

Not a fit: Patients with unstable metabolic conditions, significant liver disease, or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved dietary recommendations for managing insulin resistance and enhancing weight loss outcomes in obese patients post-bariatric surgery.

How similar studies have performed: While the specific dietary intervention in this study may be novel, previous studies have shown that dietary modifications can significantly impact insulin resistance and weight loss outcomes.

Eligibility criteria

Inclusion Criteria:

* Scheduled for a RYGB gastric bypass\*
* Men and premenopausal women \> 18 years of age
* Caucasian descent
* Ability to provide written informed consent

  \* All subjects on the waiting list meet the criteria for bariatric surgery, that is:
* BMI \> 40 kg/m2 OR \>35 kg/m2 with obesity related co-morbidity
* Reasonable supervised attempts to lose weight

Exclusion Criteria:

* Unstable metabolic condition defined as;

  * Diabetes with poor glycemic control (HbA1c \> 8.5%);
  * Use of an antidiabetic or anti-obesity drug;
  * Malabsorptive or restrictive bariatric (weight loss) surgery in history
* Evidence for a form of liver disease (except for NAFLD without cirrhosis)
* Known genetic basis for insulin resistance or glucose intolerance
* Use of certain drugs known to produce hepatic steatosis in the previous 6 months (such as oral corticosteroids, high-dose estrogens, methotrexate, tetracycline, amiodarone)
* Malabsorptive disease orders (celiac disease, inflammatory bowel disease)
* Use of certain drugs that may injure the lining of the intestine in the previous months (colchicine, cholestyramine)
* Excessive alcohol intake (≥5 IU per day or ≥ 14 IU per week)
* Recent use of antibiotics (≤ 3 months before surgery)
* Hemostasis disorders or current treatment with anticoagulants Any primary lipid disorder
* Unable to maintain diet intervention, or unable to reliably rapport diet

Where this trial is running

Amsterdam

• Amsterdam UMC location AMC — Amsterdam, Netherlands (Recruiting)

Study contacts

• Study coordinator: daniko sindhunata, MD

Conditions Insulin Resistance