Fructose and Glucose and TAS1R2 in Type 1 Diabetes
TAS1R2
Effect of Fructose and Glucose and TAS1R2 in Glucose, Triglycerides, Uremia, Oxidative Stress, Feelings Related to Food Intake of Individuals With Type 1 Diabetes
2 other identifiers
interventional
16
1 country
1
Brief Summary
- BACKGROUND: Individuals with diabetes report innate preference for sweet foods, possibly due to genetic variants. In addition, studies have shown that ingestion of fructose promotes lower postprandial blood glucose, compared to glucose. However, excessive intake may increase triglycerides, uric acid and oxidative stress, due to oxidative priority.
- AIMS: To investigate the influence of fructose and glucose and taste receptor, type 1, member 2 (TAS1R2) in glucose, triglycerides, uremia, oxidative stress, feelings related to food intake and palatability of individuals with type 1 diabetes.
- METHODS: The trial is a single-blind, two-way crossover (1-week washout) study in 30 subjects with type 1 diabetes. Blood samples were collected before and 2-hours after the participants receive 75g of fructose or 75g of glucose dissolved in 200 ml water. Capillary blood glucose were assessed at 30, 90, 120, and 180 minutes to determine glucose, and visual analogue scales for measurement of appetite sensation were assessed at 70, 120, and 190 minutes.
- PURPOSE: The research proposal adds knowledge about the TAS1R2 (Ile191Val) polymorphism and around the most suitable monosaccharide for individuals with diabetes type 1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedApril 15, 2016
April 1, 2016
1.8 years
October 19, 2012
April 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare the effects of fructose and glucose and TAS1R2 in postprandial metabolism of individuals with type 1 diabetes
Determine the blood glucose, triglycerides, oxidation of substrates, uremia, oxidative stress, feelings related to food intake of individuals with type 1 diabetes, before and 3-hours after ingestion of 75g of fructose or 75g of glucose.
baseline up to 3 hours each day study. Total study: 2 years
Secondary Outcomes (9)
Effect of fructose or glucose on blood glucose
Baseline, and up to 3-hours after solutions
Effect of fructose or glucose on triglycerides levels
Baseline, and up to 3-hours after solutions
Effect of fructose or glucose on uric acid, pyruvic acid, and lactate
Baseline, and up to 3-hours after solutions
Effect of fructose or glucose on oxidative stress
Baseline, and up to 3-hours after solutions
Effect of two polymorphisms in the gene TAS1R2 in the sweet taste perception
only at baseline
- +4 more secondary outcomes
Study Arms (2)
Glucose solution
EXPERIMENTALSolution containing 75g of glucose diluted in 200 mL of water
Fructose solution
EXPERIMENTALSolution containing 75g of fructose diluted in 200 mL of water
Interventions
The same described in Arm description
The same described in Arm description
Eligibility Criteria
You may qualify if:
- Type 1 diabetes ( ≥ three years after diagnosis)
- Adults
- Normal-weight (BMI between 18.5 e 25.0 kg/m2)
- Using basal-bolus regimen with insulin infusion pump or insulin analogs (basal: detemir or glargine; bolus: lispro, glulisine or aspart).
You may not qualify if:
- Smokers;
- Drinkers;
- Use of exogenous hormone (with the exception of insulin);
- Use of antibiotics, anti-inflammatories or oral antidiabetics pharmacotherapy;
- Diagnosis of nephropathy;
- Diagnosis of liver diseases;
- With other types of diabetes family history;
- Visual disturbances.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Rio de Janeiro, Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941-590, Brazil
Related Publications (1)
Souto DL, Lima EDS, Dantas JR, Zajdenverg L, Rodacki M, Rosado EL. Postprandial metabolic effects of fructose and glucose in type 1 diabetes patients: a pilot randomized crossover clinical trial. Arch Endocrinol Metab. 2019 Jul 29;63(4):376-384. doi: 10.20945/2359-3997000000148.
PMID: 31365624DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Débora L Souto
Ph. D. student in Nutrition Sciences at the Federal University of Rio de Janeiro, Brazil
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph. D. student in Nutrition Sciences at the Federal University of Rio de Janeiro
Study Record Dates
First Submitted
October 19, 2012
First Posted
October 24, 2012
Study Start
March 1, 2013
Primary Completion
December 1, 2014
Study Completion
January 1, 2016
Last Updated
April 15, 2016
Record last verified: 2016-04