Clinical Trial: Metabolic Consequences of Heterozygous Hereditary Fructose Intolerance

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Are Heterozygous Carriers for Hereditary Fructose Intolerance Predisposed to Metabolic Disturbances When Exposed to Fructose?

Brief 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. 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.


Detailed Summary:
Sponsor: University of Lausanne

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    Energy expenditure is measured by indirect calorimetry in fasted and fed conditions
  • 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 ]
    glucose oxidation is measured by indirect calorimetry in fasted and fed conditions
  • 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 glucose concentration measured by glucose oxidase
  • 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 ]
    Plasma insulin concentration measured by ELISA


Original Secondary Outcome: Same as current

Information By: University of Lausanne

Dates:
Date Received: November 14, 2016
Date Started: January 2015
Date Completion:
Last Updated: November 28, 2016
Last Verified: November 2016