Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT02813759
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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 ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Claudia Vega Soto, Nutritionist, Universidad de Valparaiso
ClinicalTrials.gov 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:
GLYCEMIA
SATIETY
C PEPTIDE
PRELOAD
INSULIN
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases