Hereditary Fructose IntoleranceNCT02979106
Metabolic Consequences of Heterozygous Hereditary Fructose Intolerance
A study testing Test meal in people with Hereditary Fructose Intolerance and Fructose Metabolism, Inborn Errors, run by University of Lausanne.
Trial summary
Background: High fructose intake increases blood lactate, triglyceride and uric acid concentrations. Uric acid may contribute to insulin resistance and dyslipidemia in the general population. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Fructose Intolerance, Fructose Metabolism, Inborn Errors, Glucose Metabolism Disorders
- What is being tested?
- Test meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Nov 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 8 healthy Volunteers (4 male, 4 female) parents of a child with hereditary fructose intolerance with ALDOB with heterozygous mutation of ALDOB gene
- 8 healthy Volunteers (4 male, 4 female), healthy with no mutation of ALDOB gene
Who cannot join
- Fasting glycemia > 7.0 mmol/L
- Fasting total triglycerides > 4.0 mmol/L
- Chronic renal insufficiency (eGFR ≤ 50 ml/min)
- Anemia (ferritin < 20 ug/L, hemoglobin < 13.5 ou 12.5 g/dl)
- Drugs
- Pregnancy
About this study
Official title: Are Heterozygous Carriers for Hereditary Fructose Intolerance Predisposed to Metabolic Disturbances When Exposed to Fructose?
Background: High fructose intake increases blood lactate, triglyceride and uric acid concentrations. Uric acid may contribute to insulin resistance and dyslipidemia in the general population. In patients with hereditary fructose intolerance fructose consumption is associated with acute hypoglycemia, renal tubular acidosis, and hyperuricemia.
Objective: We investigated whether asymptomatic carriers for hereditary fructose intolerance (HFI) would have a higher sensitivity to adverse effects of fructose than the general population.
Design: Eight subjects heterozygous for HFI (hHFI; 4 males, 4 females) and eight controls received for 7 days a low fructose diet and on the eighth day ingested a test meal calculated to provide 25% of basal energy requirement containing labeled fructose (13C fructose 0.35 g/kg), protein (0.21 g/kg) and lipid (0.22 g/kg). Total fructose oxidation, total endogenous glucose production (by 6,6-2H2-glucose dilution), carbohydrate and lipid oxidation, lipids, uric acid, lactate, creatinine, urea and amino acids were monitored for 6 hours.
- Conditions
- Hereditary Fructose Intolerance, Fructose Metabolism, Inborn Errors, Glucose Metabolism Disorders
- Being tested
- Test meal
- Medical subject headings
- Fructose Intolerance, Fructose Metabolism, Inborn Errors, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test mealOther
Assessment of postprandial responses to a mixed meal containing fructose in carriers of one mutated ALDOB allele.
| Study group | Role | What they receive |
|---|---|---|
| oral fructose load | Experimental | test meal calculated to provide 25% of basal energy requirement containing 13C-labeled fructose (0.35 g/kg), protein (0.21 g/kg) and lipid (0.22 g/kg). Receives: Other: Test meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose kinetics
Modelling of rate of glucose appearance after administration of a bolus of 6,6-2H2 glucose (bolus, 2 mg/kg and continuous infusion, 0.02 mg/kg/min) will be measured in fasted and fed conditions
Measured: -120 min before ingestion of a test meal to 360 min after ingestion of a test meal
Secondary outcomes (5)
Energy expenditure rate
Energy expenditure is measured by indirect calorimetry in fasted and fed conditions
Measured: 120 min before ingestion of a test meal, and every 30 min until 360 min after ingestion of a test meal
Glucose oxidation rate
glucose oxidation is measured by indirect calorimetry in fasted and fed conditions
Measured: 120 min before ingestion of a test meal, and every 30 min until 360 min after ingestion of a test meal
Plasma glucose concentration
plasma glucose concentration measured by glucose oxidase
Measured: -120 min before ingestion of a test meal, and every 30 min until 360 min after ingestion of a test meal
plasma insulin concentration
Plasma insulin concentration measured by ELISA
Measured: -120 min before ingestion of a test meal, and every 30 min until 360 min after ingestion of a test meal
Fructose oxidation
Fructose oxidation is measured from 13CO2 production
Measured: Every 30 min until 360 min after ingestion of a test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionJan 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hereditary Fructose IntoleranceStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Tappy Luc, MD, Study director, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979106
- Sponsor's protocol ID
- PB_2016-00289 (302/14)
- Status last verified
- Jul 2019
- First submitted
- 14 Nov 2016
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Debray FG, Damjanovic K, Rosset R, Mittaz-Crettol L, Roux C, Braissant O, Barbey F, Bonafe L, De Bandt JP, Tappy L, Paquot N, Tran C. Are heterozygous carriers for hereditary fructose intolerance predisposed to metabolic disturbances when exposed to fructose? Am J Clin Nutr. 2018 Aug 1;108(2):292-299. doi: 10.1093/ajcn/nqy092.
PubMed 29955837
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Heterozygous Carriers for Hereditary Fructose Intolerance Predisposed to Metabolic Disturbances When Exposed to Fructose?
- ClinicalTrials.gov ID
- NCT02979106
- Acronym / sponsor ID
- PB_2016-00289 (302/14)
- Conditions
- Hereditary Fructose Intolerance, Fructose Metabolism, Inborn Errors, Glucose Metabolism Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 1 Dec 2016 (estimated)
- 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.
Background: High fructose intake increases blood lactate, triglyceride and uric acid concentrations. Uric acid may contribute to insulin resistance and dyslipidemia in the general population. In patients with hereditary fructose intolerance fructose consumption is associated with acute hypoglycemia, renal tubular acidosis, and hyperuricemia.
Objective: We investigated whether asymptomatic carriers for hereditary fructose intolerance (HFI) would have a higher sensitivity to adverse effects of fructose than the general population.
Design: Eight subjects heterozygous for HFI (hHFI; 4 males, 4 females) and eight controls received for 7 days a low fructose diet and on the eighth day ingested a test meal calculated to provide 25% of basal energy requirement containing labeled fructose (13C fructose 0.35 g/kg), protein (0.21 g/kg) and lipid (0.22 g/kg). Total fructose oxidation, total endogenous glucose production (by 6,6-2H2-glucose dilution), carbohydrate and lipid oxidation, lipids, uric acid, lactate, creatinine, urea and amino acids were monitored for 6 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral fructose load | Experimental | Other: Test mealtest meal calculated to provide 25% of basal energy requirement containing 13C-labeled fructose (0.35 g/kg), protein (0.21 g/kg) and lipid (0.22 g/kg). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 8 healthy Volunteers (4 male, 4 female) parents of a child with hereditary fructose intolerance with ALDOB with heterozygous mutation of ALDOB gene
- 8 healthy Volunteers (4 male, 4 female), healthy with no mutation of ALDOB gene
Key exclusion criteria (6 listed)
- Fasting glycemia > 7.0 mmol/L
- Fasting total triglycerides > 4.0 mmol/L
- Chronic renal insufficiency (eGFR ≤ 50 ml/min)
- Anemia (ferritin < 20 ug/L, hemoglobin < 13.5 ou 12.5 g/dl)
- Drugs
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 |
|---|---|---|
| Test mealAssessment of postprandial responses to a mixed meal containing fructose in carriers of one mutated ALDOB allele. | Other | oral fructose load |
Primary outcome
Plasma glucose kinetics
Time frame: -120 min before ingestion of a test meal to 360 min after ingestion of a test meal
Modelling of rate of glucose appearance after administration of a bolus of 6,6-2H2 glucose (bolus, 2 mg/kg and continuous infusion, 0.02 mg/kg/min) will be measured in fasted and fed conditions
5 secondary outcomes
Energy expenditure rate
Time frame: 120 min before ingestion of a test meal, and every 30 min until 360 min after ingestion of a test meal
Glucose oxidation rate
Time frame: 120 min before ingestion of a test meal, and every 30 min until 360 min after ingestion of a test meal
Plasma glucose concentration
Time frame: -120 min before ingestion of a test meal, and every 30 min until 360 min after ingestion of a test meal
plasma insulin concentration
Time frame: -120 min before ingestion of a test meal, and every 30 min until 360 min after ingestion of a test meal
Fructose oxidation
Time frame: Every 30 min until 360 min after ingestion of a test meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Derived from this study: PubMed 29955837Debray FG, Damjanovic K, Rosset R, Mittaz-Crettol L, Roux C, Braissant O, Barbey F, Bonafe L, De Bandt JP, Tappy L, Paquot N, Tran C. Are heterozygous carriers for hereditary fructose intolerance predisposed to metabolic disturbances when exposed to fructose? Am J Clin Nutr. 2018 Aug 1;108(2):292-299. doi: 10.1093/ajcn/nqy092.
- Individual participant dataSharing planned: No
Related trials for Hereditary Fructose Intolerance
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
Not yet recruiting
New Microbiota-endocrine Axis in Fructose Malabsorption-caused Visceral Hypersensitivity in Irritable Bowel Syndrome.
Irritable Bowel Syndrome (IBS)
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.
Tappy Luc, MD study director
University of Lausanne
Questions about this trial
What is this clinical trial studying?
A study testing Test meal in people with Hereditary Fructose Intolerance and Fructose Metabolism, Inborn Errors, run by University of Lausanne.
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 2 inclusion and 6 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: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose kinetics (time frame: -120 min before ingestion of a test meal to 360 min after ingestion of a test meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02979106, which also lists 1 linked publication.
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 17 Jul 2019.