Sucralose in Subjects With Diabetes Mellitus Insulin Requesting (SDMIR)

June 22, 2016 updated by: Claudia Vega Soto, Universidad de Valparaiso

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemia
Time Frame: up to 120 minutes
Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.
up to 120 minutes
C peptide
Time Frame: up to 60 minutes
C-peptide at -15 and 60 minutes with respect to breakfast intake
up to 60 minutes
Satiety
Time Frame: up to 120 minutes
Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).
up to 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Valparaiso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 22, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Sucralose

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe