Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: November 2015

Interventions

  • Other: Low glycemic index
    • Subjects intake a low glycemic index breakfast
  • Other: High glycemic index
    • Subjects intake a high glycemic index breakfast

Arms, Groups and Cohorts

  • Experimental: Low glycemic index breakfast
    • Low glycemic index breakfast (GI=45)
  • Active Comparator: High glycemic index breakfast
    • High glycemic index breakfast (GI=80)

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 47 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidad de Valparaiso
  • Provider of Information About this Clinical Study
    • Principal Investigator: Claudia Vega Soto, Nutritionist – Universidad de Valparaiso

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.