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Clinical Trials/NCT02813759
NCT02813759CompletedNot Applicable

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

Universidad de Valparaiso0 sites10 target enrollmentStarted: July 1, 2015Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Primary Endpoint
Glycemia
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
Single (Participant)

Eligibility Criteria

Ages
35 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Water

Placebo Comparator

200 mL of water

Intervention: Placebo (Other)

Sucralose

Experimental

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

Intervention: Sucralose (Other)

Outcomes

Primary Outcomes

Glycemia

Time Frame: up to 120 minutes

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

Satiety

Time Frame: up to 120 minutes

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

C peptide

Time Frame: up to 60 minutes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claudia Vega Soto

Nutritionist

Universidad de Valparaiso

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