Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting

Diabetes Mellitus, Type 2 Clinical Trial

— GIDMIR  

Official title:

Effect of Glycemic Index of a Preparation 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: NCT02881164
• Other study ID #: 17-2015
• Status: Completed
• Phase: N/A
• First received: August 23, 2016
• Last updated: August 25, 2016
• Start date: July 2015
• Est. completion date: August 2016

Study information

• Verified date: August 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 low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 47 Years to 64 Years

Eligibility

Inclusion Criteria:

• Subjects with type 2 diabetes mellitus diagnosis.

• Minimum period of six months under intensive insulin therapy.

• Fast insulin prescription before breakfast.

• 35 and 70 years of age.

• BMI between 25 and 39.9 Kg/m2.

• HbA1c less than or equal to 10 % (86mmol/mol)

• Menopausal women under hormone replacement therapy

Exclusion Criteria:

• Pregnant women.

• Puerperal women.

• Subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus.

• Subjects with history of stroke, acute myocardial infarction or 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:
• Low glycemic index
Subjects intake a low glycemic index breakfast
• High glycemic index
Subjects intake a high glycemic index 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	-15 up to 120 minutes	No
Primary	Satiety	Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).	Up to 120 minutes	No