Sucralose in Subjects With Diabetes Mellitus Insulin Requesting

NCT ID: NCT02813759

Last Updated: 2016-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sucralose

14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water

Group Type EXPERIMENTAL

Sucralose

Intervention Type OTHER

Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.

Water

200 mL of water

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sucralose

Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.

Intervention Type OTHER

Placebo

Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Water

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad de Valparaiso

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Claudia Vega Soto

Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.

Reference Type DERIVED
PMID: 32449201 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

17/2015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.