Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Low glycemic index breakfast

Low glycemic index breakfast (GI=45)

Group Type EXPERIMENTAL

Low glycemic index

Intervention Type OTHER

Subjects intake a low glycemic index breakfast

High glycemic index breakfast

High glycemic index breakfast (GI=80)

Group Type ACTIVE_COMPARATOR

High glycemic index

Intervention Type OTHER

Subjects intake a high glycemic index breakfast

Interventions

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Low glycemic index

Subjects intake a low glycemic index breakfast

Intervention Type OTHER

High glycemic index

Subjects intake a high glycemic index breakfast

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

47 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No