Sucralose in Subjects With Diabetes Mellitus Insulin Requesting

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02813759

Acronym

SDMIR

Enrollment

Registered

2016-06-27

Start date

2015-07-31

Completion date

2016-01-31

Last updated

2016-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

GLYCEMIA, SATIETY, C PEPTIDE, PRELOAD, INSULIN

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).

Interventions

OTHERSucralose

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

OTHERPlacebo

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026