Sucralose in Subjects With Diabetes Mellitus Insulin Requesting

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02813759
• Other study ID #: 17/2015
• Status: Completed
• Phase: N/A
• First received: June 16, 2016
• Last updated: June 22, 2016
• Start date: July 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Universidad de Valparaiso
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Sucralose
Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.
• Placebo
Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Valparaiso

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemia	Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake.	up to 120 minutes	No
Primary	C peptide	C-peptide at -15 and 60 minutes with respect to breakfast intake	up to 60 minutes	No
Primary	Satiety	Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).	up to 120 minutes	No