Sucralose in Subjects With Diabetes Mellitus Insulin Requesting
Not Applicable
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: PlaceboOther: Sucralose
- Registration Number
- NCT02813759
- Lead Sponsor
- Universidad de Valparaiso
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Water Placebo 200 mL of water Sucralose Sucralose 14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water
- Primary Outcome Measures
Name Time Method Glycemia up to 120 minutes Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.
Satiety up to 120 minutes Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).
C peptide up to 60 minutes C-peptide at -15 and 60 minutes with respect to breakfast intake
- Secondary Outcome Measures
Name Time Method