Sucralose in Subjects With Diabetes Mellitus Insulin Requesting

Universidad de Valparaiso10 enrolled

Overview

To evaluate the acute effect of a preload of sucralose in presence of carbohydrate (HC) available on the glycemic response, postprandial C peptide and satiety in patients with type 2 diabetes mellitus (DM2) in intensive insulin therapy (IIT).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

SucraloseOTHER

Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.

PlaceboOTHER

Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Minimum period of six month intensive insulin therapy * Prescription rapid insulin in the breakfast * Aged 35 to 70 years * BMI 25 to 39.9 kg / m2 * HbA1c lower than or equal to 10% (86 mmol / mol) * Menopausal women under hormone replacement therapy Exclusion Criteria: * History of intolerance artificial sweetener sucralose * Pregnant women * Puerperal women * Subjects with neurological disease, endocrine disorder no treatment, kidney disease stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, HIV * Subjects with history of stroke , acute myocardial infarction and gastrointestinal resection

Outcomes

Primary Outcomes

Glycemia

Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.

Time frame: up to 120 minutes

C peptide

C-peptide at -15 and 60 minutes with respect to breakfast intake

Time frame: up to 60 minutes

Satiety

Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).

Time frame: up to 120 minutes

Data from ClinicalTrials.gov

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