Sucralose in Subjects With Diabetes Mellitus Insulin Requesting (SDMIR)
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|ClinicalTrials.gov Identifier: NCT02813759|
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Universidad de Valparaiso
Information provided by (Responsible Party):
Claudia Vega Soto, Universidad de Valparaiso
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).
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Other: Sucralose Other: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of a Sucralose Preload on Postprandial Metabolic Parameters and Satiety in Subjects With Type 2 Diabetes Mellitus Under Intensive Insulin Therapy - Controlled Clinical Trial|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||January 2016|
14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water
Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.
Placebo Comparator: Water
200 mL of water
Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.
Other Name: Water
Primary Outcome Measures :
- Glycemia [ Time Frame: up to 120 minutes ]Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.
- C peptide [ Time Frame: up to 60 minutes ]C-peptide at -15 and 60 minutes with respect to breakfast intake
- Satiety [ Time Frame: up to 120 minutes ]Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).
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