Skip to content

Bariatric surgery and fructose handling in obese subjects

Bariatric surgery and fructose handling in obese subjects - BREADFRUIT STUDY

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51827
Enrollment
20
Registered
2022-10-31
Start date
2023-08-22
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insuline resistentie suikerziekte

Interventions

Subjects will be put on either their normal regular diet (>100 gram fructose / day) versus a low fructose diet (

Sponsors

Vasculaire Geneeskunde
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Scheduled for a RYGB gastric bypass at Spaarne Gasthuis* - 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 - 18-65 years of age

Exclusion criteria

Exclusion criteria: - Unstable metabolic condition defined as; o diabetes with poor glycemic control (HbA1c > 8.5%), or use of an antidiabetic or anti-obesity drug; o 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 (

Design outcomes

Primary

MeasureTime frame
Primary endpoints are changes in oral fructose handling (measured by a fructose tolerance test with 120mg 13C6-labeled fructose in relation to glucose handling (HOMA and Freestyle Libre) at baseline and after 4 weeks (in the week of surgery) after both diets.

Secondary

MeasureTime frame
Secondary endpoints are changes in histology and RNA seq gene expression in liver, adipose and jejunum tissue harvested with biopsy during bariatric surgery and changes in fecal gut microbiota composition, 24h feces and urine for fructose content and (postprandial) plasma metabolites including endogenous ethanol at both timepoints. Of note, dietary intake including fructose content will be monitored by an experienced dietician from Spaarne Gasthuis. Finally, to study relations with (long term) weight loss up to 1 year after surgery related to dietary intake, the last time points at 6 and 12 months after surgery (during regular clinical outpatient visits) will be used as an exploratory endpoint to gain more insight into the relationship between gut microbiota, (pre surgery) dietary fructose intake and weight loss after bariatric surgery.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)