Fructose and Glucose and TAS1R2 in Type 1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Universidade Federal do Rio de Janeiro
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Débora Lopes Souto, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01713023
First received: October 19, 2012
Last updated: March 26, 2014
Last verified: March 2014
  Purpose
  • 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.

Condition Intervention
Type 1 Diabetes
Dietary Supplement: Glucose
Dietary Supplement: Fructose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Effect of Fructose and Glucose and TAS1R2 in Glucose, Triglycerides, Uremia, Oxidative Stress, Feelings Related to Food Intake of Individuals With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Universidade Federal do Rio de Janeiro:

Primary Outcome Measures:
  • Compare the effects of fructose and glucose and TAS1R2 in postprandial metabolism of individuals with type 1 diabetes [ Time Frame: baseline up to 3 hours each day study. Total study: 2 years ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Effect of fructose or glucose on blood glucose [ Time Frame: Baseline, and up to 3-hours after solutions ] [ Designated as safety issue: Yes ]

    Determine the peak plasma blood glucose before and 3-hours after ingestion of 75g of fructose or 75g of glucose.

    We also test capillary blood glucose before and 30, 90, 120, and 180 minutes after solutions.


  • Effect of fructose or glucose on triglycerides levels [ Time Frame: Baseline, and up to 3-hours after solutions ] [ Designated as safety issue: No ]
    Determine the triglycerides levels before and 3-hours after ingestion of 75g of fructose or 75g of glucose.

  • Effect of fructose or glucose on uric acid, pyruvic acid, and lactate [ Time Frame: Baseline, and up to 3-hours after solutions ] [ Designated as safety issue: No ]
    Determine the uric acid, pyruvic acid, and lactate levels before and 3-hours after ingestion of 75g of fructose or 75g of glucose.

  • Effect of fructose or glucose on oxidative stress [ Time Frame: Baseline, and up to 3-hours after solutions ] [ Designated as safety issue: No ]
    Determine the malondialdehyde level before and 3-hours after ingestion of 75g of fructose or 75g of glucose.

  • Effect of two polymorphisms in the gene TAS1R2 in the sweet taste perception [ Time Frame: only at baseline ] [ Designated as safety issue: Yes ]

    TAS1R2 (taste receptor, type 1, member 2 T1R2) is the component specific to sweet taste perception, and does not change during the life.

    We will determine whether Ser9Cys (dbSNP: rs9701796) and Ile191Val (dbSNP: rs35874116)variations in TAS1R2 were associated with differences the sweet taste perceptions.


  • Effect of fructose or glucose on blood glucose [ Time Frame: Baseline, and up to 3-hours after solutions ] [ Designated as safety issue: Yes ]

    Determine the peak plasma blood glucose before and 3-hours after ingestion of 75g of fructose or 75g of glucose.

    We also test capillary blood glucose before and 30, 90, 120 and 180 minutes after solutions.


  • Effect of fructose or glucose on appetite and palatability [ Time Frame: Baseline, and up 120 minutes ] [ Designated as safety issue: No ]

    Two different visual analogue scales will be used to assess hunger, satiety, fullness, prospective food consumption, palatability, taste, aftertaste, smell, and visual appeal of the solutions.

    The scales will be performed at 7, 35, 95 and 120 minutes after solutions.


  • Effect of fructose or glucose on glucagon levels [ Time Frame: Baseline, and up to 3-hours after solutions ] [ Designated as safety issue: Yes ]
    Determine the glucagon levels before and 3-hours after ingestion of 75g of fructose or 75g of glucose

  • Effect of fructose or glucose on leptin levels [ Time Frame: Baseline, and up to 3-hours after solutions ] [ Designated as safety issue: Yes ]
    Determine the leptin levels before and 3-hours after ingestion of 75g of fructose or 75g of glucose


Estimated Enrollment: 30
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucose solution
Solution containing 75g of glucose diluted in 200 mL of water
Dietary Supplement: Glucose
The same described in Arm description
Other Name: 75g of glucose diluted in 200 mL of water
Dietary Supplement: Fructose
The same described in Arm description
Other Name: 75g of fructose diluted in 200 mL of water
Experimental: Fructose solution
Solution containing 75g of fructose diluted in 200 mL of water
Dietary Supplement: Glucose
The same described in Arm description
Other Name: 75g of glucose diluted in 200 mL of water
Dietary Supplement: Fructose
The same described in Arm description
Other Name: 75g of fructose diluted in 200 mL of water

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713023

Contacts
Contact: Débora L Souto, Dra 55 (21) 2260-4139 deboralopessouto@gmail.com

Locations
Brazil
University Hospital of Rio de Janeiro, Federal University of Rio de Janeiro Recruiting
Rio de Janeiro, Brazil, 21941-590
Contact: Débora L Souto    55 (21) 2260-4139    deboralopessouto@gmail.com   
Contact: Érika S Lima       erikalima.nutri@gmail.com   
Principal Investigator: Débora L Souto         
Sub-Investigator: Eliane L Rosado         
Sub-Investigator: Érika S Lima         
Sub-Investigator: Melanie Rodacki         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Principal Investigator: Débora L Souto Ph. D. student in Nutrition Sciences at the Federal University of Rio de Janeiro, Brazil
  More Information

Additional Information:
No publications provided

Responsible Party: Débora Lopes Souto, Ph. D. student in Nutrition Sciences at the Federal University of Rio de Janeiro, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01713023     History of Changes
Other Study ID Numbers: Debora-TAS1R2, CEP-151/2011
Study First Received: October 19, 2012
Last Updated: March 26, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Federal do Rio de Janeiro:
type 1 diabetes
fructose
glucose
TAS1R2
oxidative stress

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014