Insulin ResistanceBREADFRUITNCT05717595
BaRiatric Surgery AnD FRUctose Handeling In Obese subjecTs
A study testing fructose in people with Insulin Resistance, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
To investigate whether changes in fructose dietary intake can help to improve dietary fructose-induced insulin resistance and post bariatric weight loss in obese subjects of Caucasian descent Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- fructose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Feb 2023to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC location AMC
Amsterdam
max nieuwdorp, MD PhD, 0031 20 5669111, m.nieuwdorp@amsterdamumc.nl
About this study
To investigate whether changes in fructose dietary intake can help to improve dietary fructose-induced insulin resistance and post bariatric weight loss in obese subjects of Caucasian descent
Read the detailed description
In this Randomized controlled trial, males and premenopausal women, scheduled for RYGB bariatric surgery at Spaarne Gasthuis of Caucasian Dutch descent, age ≥18 years will be put on either their high fructose diet (>100 gram fructose / day) versus a low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) 4 weeks before bariatric surgery. For both groups, an oral (13-C labeled) fructose challenge will be performed at baseline as well as 4 weeks after start of the diet (in the week of the surgery).
Outcome measures: Primary endpoints are changes in oral fructose induced glucose and insulin postprandial plasma excursions (measured by a fructose tolerance test with 120mg 13C6-labeled fructose in relation to long term glucose handling (HOMA and Freestyle Libre) at baseline and after 4 weeks (in the week of surgery) after both diets. 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.
- Conditions
- Insulin Resistance
- Being tested
- fructose
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fructoseDietary supplement
Also called dextrose
oral ingestion of fructose vs dextrose
| Study group | Role | What they receive |
|---|---|---|
| high fructose | Other | high fructose (>100 gram fructose / day) for 4 weeks Receives: Dietary Supplement: fructose |
| low fructose | Other | low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks Receives: Dietary Supplement: fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral fructose handling
to correlate changes in oral fructose excursions (measured by AUC of fructose tolerance test enriched with 13C6-labeled fructose with glucose excursions (MAGE by Freestyle Libre)
Measured: 4 weeks
Secondary outcomes (4)
fructose changes in visceral organs
to correlate with changes in histology and RNA seq gene expression in liver, adipose and jejunum tissue harvested with biopsy during bariatric surgery
Measured: 4 weeks up to one year
gutmicrobiota
to correlate with changes in fecal gut microbiota composition
Measured: 4 weeks up to one year
metabolites
to correlate with (postprandial) plasma metabolites including endogenous ethanol
Measured: 4 weeks up to one year
weight
to correlate with with (long term) weight loss at 6 and 12 months after surgery
Measured: 4 weeks up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start5 Feb 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double blinded trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Nieuwdorp, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717595
- Sponsor's protocol ID
- 2022.0595 - NL8236601822
- Acronym
- BREADFRUIT
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not allowed due to GDPR in Netherlands
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BaRiatric Surgery AnD FRUctose Handeling In Obese subjecTs
- ClinicalTrials.gov ID
- NCT05717595
- Acronym / sponsor ID
- BREADFRUIT / 2022.0595 - NL8236601822
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 5 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether changes in fructose dietary intake can help to improve dietary fructose-induced insulin resistance and post bariatric weight loss in obese subjects of Caucasian descent
Detailed description
In this Randomized controlled trial, males and premenopausal women, scheduled for RYGB bariatric surgery at Spaarne Gasthuis of Caucasian Dutch descent, age ≥18 years will be put on either their high fructose diet (>100 gram fructose / day) versus a low fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) 4 weeks before bariatric surgery. For both groups, an oral (13-C labeled) fructose challenge will be performed at baseline as well as 4 weeks after start of the diet (in the week of the surgery).
Outcome measures: Primary endpoints are changes in oral fructose induced glucose and insulin postprandial plasma excursions (measured by a fructose tolerance test with 120mg 13C6-labeled fructose in relation to long term glucose handling (HOMA and Freestyle Libre) at baseline and after 4 weeks (in the week of surgery) after both diets. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized double blinded trial
| Arm | Type | Receives |
|---|---|---|
| high fructose | Other | Dietary Supplement: fructosehigh fructose (>100 gram fructose / day) for 4 weeks |
| low fructose | Other | Dietary Supplement: fructoselow fructose diet (<30 gram fructose intake per day isocaloric correction with dextrose) for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Scheduled for a RYGB gastric bypass*
- Men and premenopausal women > 18 years of age
- Caucasian descent
- Ability to provide written informed consent
- BMI > 40 kg/m2 OR >35 kg/m2 with obesity related co-morbidity
Key exclusion criteria (13 listed)
- Unstable metabolic condition defined as;
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fructoseAlso: dextroseoral ingestion of fructose vs dextrose | Dietary supplement | high fructose, low fructose |
Primary outcome
oral fructose handling
Time frame: 4 weeks
to correlate changes in oral fructose excursions (measured by AUC of fructose tolerance test enriched with 13C6-labeled fructose with glucose excursions (MAGE by Freestyle Libre)
4 secondary outcomes
fructose changes in visceral organs
Time frame: 4 weeks up to one year
gutmicrobiota
Time frame: 4 weeks up to one year
metabolites
Time frame: 4 weeks up to one year
weight
Time frame: 4 weeks up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No. not allowed due to GDPR in Netherlands
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fructose in people with Insulin Resistance, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact daniko sindhunata, MD (0031 20 5669111, d.p.sindhunata@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral fructose handling (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.