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Completed

NCT Number: NCT02881164

Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting

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.

Completed

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

47 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low glycemic index

Other

Subjects intake a low glycemic index breakfast

High glycemic index

Other

Subjects intake a high glycemic index breakfast

Primary outcomes

  1. Glycemia

    Time frame: -15 up to 120 minutes

    Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake

  2. Satiety

    Time frame: Up to 120 minutes

    Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).

Sponsors and collaborators

Lead sponsor

Universidad de Valparaiso

Other

Registry information

Official study 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

Acronym: GIDMIR

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Aug 26, 2016
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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