NCT01713023

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

1.8 years

First QC Date

October 19, 2012

Last Update Submit

April 14, 2016

Conditions

Keywords

type 1 diabetesfructoseglucoseTAS1R2oxidative stress

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

EXPERIMENTAL

Solution containing 75g of glucose diluted in 200 mL of water

Dietary Supplement: GlucoseDietary Supplement: Fructose

Fructose solution

EXPERIMENTAL

Solution containing 75g of fructose diluted in 200 mL of water

Dietary Supplement: GlucoseDietary Supplement: Fructose

Interventions

GlucoseDIETARY_SUPPLEMENT

The same described in Arm description

Also known as: 75g of glucose diluted in 200 mL of water
Fructose solutionGlucose solution
FructoseDIETARY_SUPPLEMENT

The same described in Arm description

Also known as: 75g of fructose diluted in 200 mL of water
Fructose solutionGlucose solution

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

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.

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

GlucoseWaterFructose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsKetoses

Study Officials

  • Débora L Souto

    Ph. D. student in Nutrition Sciences at the Federal University of Rio de Janeiro, Brazil

    PRINCIPAL INVESTIGATOR

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

Locations