Bariatric surgery and fructose handling in obese subjects

Recruiting

Conditions: Insuline resistentie
suikerziekte
10018424

Registration Number: NL-OMON51827

Lead Sponsor: Vasculaire Geneeskunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

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

- 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 (<= 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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