Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting (GIDMIR)

Universidad de Valparaiso

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Low glycemic index; Other: High glycemic index

Study type: Interventional

Funder types: Other

Identifiers

NCT02881164

17-2015

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 47 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Low glycemic index breakfast

Experimental group

Description:

Low glycemic index breakfast (GI=45)

Treatment:

Other: Low glycemic index

High glycemic index breakfast

Active Comparator group

Description:

High glycemic index breakfast (GI=80)

Treatment:

Other: High glycemic index