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

August 25, 2016 updated by: Claudia Vega Soto, Universidad de Valparaiso

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low glycemic index breakfast
Low glycemic index breakfast (GI=45)
Other: Low glycemic index
Subjects intake a low glycemic index breakfast
Active Comparator: High glycemic index breakfast
High glycemic index breakfast (GI=80)
Other: High glycemic index
Subjects intake a high glycemic index breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemia
Time Frame: -15 up to 120 minutes
Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake
-15 up to 120 minutes
Satiety
Time Frame: Up to 120 minutes
Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).
Up to 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Valparaiso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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