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

NCT02758483 | Completed DMC

• 1 other identifier: UFRJNutrology
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Compare the intraday and interday glucose variability effect of sucrose-free with a sucrose-free diet for patients with type 1 diabetes.

  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).

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Evaluate the intraday glycemic variability effect of foods containing different macronutrients quantity, through CONGA index.

  Through study completion, an average of 1 year

• Compare the intraday glycemic variability effect of sucrose-free diet and sucrose-added diet, through MAGE index, in patients with type 1 diabetes

  Through study completion, an average of 1 year

• Compare the interday glycemic variability effect of sucrose-free diet and sucrose-added diet, through MODD index, in patients with type 1 diabetes

  Through study completion, an average of 1 year

Study Arms (2)

Test diet

OTHER

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

Control diet

OTHER

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

Interventions

Control diet OTHER

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

Control diet

Test Diet OTHER

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

Test diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Clementino Fraga Filho University Hospital of Rio de Janeiro

Rio de Janeiro, 21941-913, Brazil

Location

Related Publications (1)

• Souto DL, Dantas JR, Oliveira MMDS, Rosado EL, Luiz RR, Zajdenverg L, Rodacki M. Does sucrose affect the glucose variability in patients with type 1 diabetes? a pilot crossover clinical study. Nutrition. 2018 Nov;55-56:179-184. doi: 10.1016/j.nut.2018.05.009. Epub 2018 Jun 8.

  PMID: 30086487 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Melanie Rodacki, PhD

  Universidade Federal do Rio de Janeiro

  STUDY CHAIR

• Lenita Zajdenverg, PhD

  Universidade Federal do Rio de Janeiro

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: April 14, 2016
• First Posted: May 2, 2016
• Study Start: March 23, 2017
• Primary Completion: July 31, 2017
• Study Completion: January 1, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

BR (1)