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Sucralose in Subjects With Diabetes Mellitus Insulin Requesting (SDMIR)

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Sucralose

Placebo

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring GLYCEMIA, SATIETY, C PEPTIDE, PRELOAD, INSULIN

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sucralose

Water

Arm Description

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

200 mL of water

Outcomes

Primary Outcome Measures

Glycemia

Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.

C peptide

C-peptide at -15 and 60 minutes with respect to breakfast intake

Satiety

Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).

Secondary Outcome Measures

Full Information

NCT ID

NCT02813759

First Posted

June 16, 2016

Last Updated

June 22, 2016

Sponsor

Universidad de Valparaiso

1. Study Identification

Unique Protocol Identification Number

NCT02813759

Brief Title

Sucralose in Subjects With Diabetes Mellitus Insulin Requesting

Acronym

SDMIR

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 Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad de Valparaiso

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

GLYCEMIA, SATIETY, C PEPTIDE, PRELOAD, INSULIN

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sucralose

Arm Type

Experimental

Arm Description

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

Arm Title

Water

Arm Type

Placebo Comparator

Arm Description

200 mL of water

Intervention Type

Other

Intervention Name(s)

Sucralose

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Water

Intervention Description

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

Primary Outcome Measure Information:

Title

Glycemia

Description

Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.

Time Frame

up to 120 minutes

Title

C peptide

Description

C-peptide at -15 and 60 minutes with respect to breakfast intake

Time Frame

up to 60 minutes

Title

Satiety

Description

Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).

Time Frame

up to 120 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32449201

Citation

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.

Results Reference

derived

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Sucralose in Subjects With Diabetes Mellitus Insulin Requesting

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