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Sucralose in Subjects With Diabetes Mellitus Insulin Requesting (SDMIR)

U

Universidad de Valparaiso

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: Sucralose
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02813759
17/2015

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

All

Ages

35 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

10 participants in 2 patient groups, including a placebo group

Sucralose
Experimental group
Description:
14 mg sucralose (Zero K sucralose powder, IANSA®) an 200 mL of water
Treatment:
Other: Sucralose
Water
Placebo Comparator group
Description:
200 mL of water
Treatment:
Other: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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