Sucralose in Subjects With Diabetes Mellitus Insulin Requesting (SDMIR)

Universidad de Valparaiso

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Sucralose; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02813759

17/2015

Details and patient eligibility

About

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).

Enrollment: 10 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups, including a placebo group

Sucralose

Experimental group

Description:

14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water

Treatment:

Other: Sucralose

Water

Placebo Comparator group

Description:

200 mL of water

Treatment:

Other: Placebo