NCT02813759

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

4 months

First QC Date

June 16, 2016

Last Update Submit

June 22, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

GLYCEMIASATIETYC PEPTIDEPRELOADINSULIN

Outcome Measures

Primary Outcomes (3)

  • Glycemia

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

    up to 120 minutes

  • C peptide

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

    up to 60 minutes

  • Satiety

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

    up to 120 minutes

Study Arms (2)

Sucralose

EXPERIMENTAL

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

Other: Sucralose

Water

PLACEBO COMPARATOR

200 mL of water

Other: Placebo

Interventions

SucraloseOTHER

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

Sucralose
PlaceboOTHER

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

Also known as: Water
Water

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32449201DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Interventions

trichlorosucroseWater

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutritionist

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 27, 2016

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

June 27, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share