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Sucralose in Subjects With Diabetes Mellitus Insulin Requesting (SDMIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02813759
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Information provided by (Responsible Party):
Claudia Vega Soto, 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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Other: Sucralose Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Sucralose
14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water
Other: Sucralose
Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.

Placebo Comparator: Water
200 mL of water
Other: Placebo
Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.
Other Name: Water

Primary Outcome Measures :
  1. Glycemia [ Time Frame: up to 120 minutes ]
    Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.

  2. C peptide [ Time Frame: up to 60 minutes ]
    C-peptide at -15 and 60 minutes with respect to breakfast intake

  3. Satiety [ Time Frame: up to 120 minutes ]
    Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Claudia Vega Soto, Nutritionist, Universidad de Valparaiso Identifier: NCT02813759    
Other Study ID Numbers: 17/2015
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: June 27, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Claudia Vega Soto, Universidad de Valparaiso:
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases