Fructose and Glucose and TAS1R2 in Type 1 Diabetes
This study is currently recruiting participants.
Verified March 2013 by Federal University of Rio de Janeiro
Sponsor:
Federal University of Rio de Janeiro
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Débora Lopes Souto, Federal University of Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01713023
First received: October 19, 2012
Last updated: March 19, 2013
Last verified: March 2013
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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:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Dextrose
U.S. FDA Resources
Further study details as provided by Federal University of 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.
- 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, 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 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 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 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 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 fructose or glucose on appetite and palatability [ Time Frame: 0, 70, 130, and 190 minutes after solutions ] [ 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
- Effect of polymorphism in TAS1R2 (Ile191Val) on sweet taste perception [ Time Frame: only at baseline ] [ Designated as safety issue: No ]TAS1R2 (taste receptor, type 1, member 2 T1R2) is the component specific to sweet taste perception, and does not change during the life.
- Effect of fructose or glucose on blood glucose [ Time Frame: Baseline, and 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.
| 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
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
Federal University of 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, Federal University of 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 19, 2013 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of 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 May 19, 2013