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Completed

NCT Number: NCT02813759

Sucralose in Subjects With Diabetes Mellitus Insulin Requesting

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).

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sucralose

Other

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

Placebo

Other

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

Other names: Water

Primary outcomes

  1. Glycemia

    Time frame: up to 120 minutes

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

  2. C peptide

    Time frame: up to 60 minutes

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

  3. Satiety

    Time frame: up to 120 minutes

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

Sponsors and collaborators

Lead sponsor

Universidad de Valparaiso

Other

Registry information

Official study 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

Acronym: SDMIR

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jun 27, 2016
Registry last updated
Jun 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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