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Trial record 13 of 2794 for:    Type 1 Diabetes

Glucose Variability in Patients With Type 1 Diabetes With a Sucrose-added Diet

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ClinicalTrials.gov Identifier: NCT02758483
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

BACKGROUND: The treatment with continuous glucose monitoring system (CGMS) offers improved glycemic control for patients with type 1 diabetes. However, patients with type 1 diabetes usually intake foods with sugar, even without hypoglycemic episodes, and the use of advanced carbohydrate counting method may increase the calories and carbohydrate intake.

OBJECTIVE: To evaluate and compare the influence of sucrose-free diet or sucrose-added diet on glucose variability in patients with type 1 diabetes.

METHODS: The study was a simple-blind, two-way crossover design in which patients with type 1 diabetes will receive a control diet (a diet with a little quantity of sugars) or test diet (with foods containing moderate quantity of sucrose in composition) during two-days each. During the intervention, all foods and drinks intake will have to be documented to allow quantitative estimation of dietary intake, to verify adherence to the diets. After one-week, each patient will return for download CGMS.

PURPOSE: The research proposal adds knowledge about the glucose variability in patients with type 1 diabetes who use foods with sugar in theirs habitual dietary intake.


Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Other: Control diet Other: Test Diet

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Influence of Sucrose-free Diet or Sucrose-added Diet on Glucose Variability in Patients With Type 1 Diabetes
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Sucrose
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Test diet

Diet with foods containing moderate quantity of sucrose in composition (80.22g; 30.2% of total carbohydrates of the diet).

Note: Both diets had the same calories, carbohydrates, proteins, fat, and fiber, and were prescribed according to the American Diabetes Association recommendations.

Other: Test Diet
Diet with foods containing moderate quantity of sucrose in composition (80.22g; 30.2% of total carbohydrates of the diet).
Control diet

Diet with a little quantity of sugars (30.40g; 12.7% of total carbohydrates of the diet).

Note: Both diets had the same calories, carbohydrates, proteins, fat, and fiber, and were prescribed according to the American Diabetes Association recommendations.

Other: Control diet
Diet with a little quantity of sugars (30.40g; 12.7% of total carbohydrates of the diet).


Outcome Measures

Primary Outcome Measures :
  1. Compare the intraday and interday glucose variability effect of sucrose-free with a sucrose-free diet for patients with type 1 diabetes. [ Time Frame: Through study completion, an average of 1 year ]

    Intraday and interday glucose variability will be evaluated by the following indexes:

    CONGA: continuous overall net glycemic action (mmol/L); MAGE: mean amplitude of glycemic excursion (mmol/L); MODD: mean of daily diferences (mmol/L).



Secondary Outcome Measures :
  1. Evaluate the intraday glycemic variability effect of foods containing different macronutrients quantity, through CONGA index. [ Time Frame: Through study completion, an average of 1 year ]
    CONGA: continuous overall net glycemic action (mmol/L

  2. Compare the intraday glycemic variability effect of sucrose-free diet and sucrose-added diet, through MAGE index, in patients with type 1 diabetes [ Time Frame: Through study completion, an average of 1 year ]
    MAGE: mean amplitude of glycemic excursion (mmol/L)

  3. Compare the interday glycemic variability effect of sucrose-free diet and sucrose-added diet, through MODD index, in patients with type 1 diabetes [ Time Frame: Through study completion, an average of 1 year ]
    MODD: mean of daily diferences (mmol/L


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes ( ≥ three years after diagnosis)
  • Adults
  • Using basal-bolus regimen with multiple insulin injections with long-acting insulin analogues (glargine, detemir, or degludec) combined with a short-acting analogs (aspart, lispro or glulisina) OR Continuous subcutaneous insulin infusion

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 (Creatinine clearance <90mL/min/1,73m2)
  • Gastroparesis symptoms
  • Celiac disease
  • Hypothyroidism or hyperthyroidism
  • Other types of diabetes family history
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758483


Contacts
Contact: Débora L Souto, PhD +55(21)22604139 deboralopessouto@gmail.com
Contact: Débora L Souto, PhD +55(21)991423642 deborasouto@openlink.com.br

Locations
Brazil
Clementino Fraga Filho University Hospital of Rio de Janeiro Recruiting
Rio de Janeiro, Brazil, 21941-913
Contact: Débora L Souto, PhD    +55(21)22604139    deboralopessouto@gmail.com   
Sub-Investigator: Melanie Rodacki, PhD         
Sub-Investigator: Lenita Zajdenverg, PhD         
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
Study Chair: Melanie Rodacki, PhD Universidade Federal do Rio de Janeiro
Study Chair: Lenita Zajdenverg, PhD Universidade Federal do Rio de Janeiro
More Information

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 63683417.1.0000.5257

Responsible Party: Débora Lopes Souto, Ph.D, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02758483     History of Changes
Other Study ID Numbers: UFRJNutrology
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The study was approved by Ethical Committee (Institutional Review Board)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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