Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting
GIDMIR
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
1 other identifier
interventional
10
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Jul 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 23, 2016
CompletedFirst Posted
Study publicly available on registry
August 26, 2016
CompletedAugust 26, 2016
August 1, 2016
4 months
August 23, 2016
August 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Glycemia
Glycemia (mg/dL) to -15, 30, 60 and 120 minutes, with respect to breakfast intake
-15 up to 120 minutes
Satiety
Visual Analog Scale (VAS) was applied immediate and tardy postprandial (two hours after eating breakfast).
Up to 120 minutes
Study Arms (2)
Low glycemic index breakfast
EXPERIMENTALLow glycemic index breakfast (GI=45)
High glycemic index breakfast
ACTIVE COMPARATORHigh glycemic index breakfast (GI=80)
Interventions
Subjects intake a high glycemic index breakfast
Eligibility Criteria
You may qualify if:
- Subjects with type 2 diabetes mellitus diagnosis.
- Minimum period of six months under intensive insulin therapy.
- Fast insulin prescription before breakfast.
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Lobos DR, Vicuna IA, Novik V, Vega CA. Effect of high and low glycemic index breakfast on postprandial metabolic parameters and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy: Controlled clinical trial. Clin Nutr ESPEN. 2017 Aug;20:12-16. doi: 10.1016/j.clnesp.2017.04.082. Epub 2017 May 11.
PMID: 29072163DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nutritionist
Study Record Dates
First Submitted
August 23, 2016
First Posted
August 26, 2016
Study Start
July 1, 2015
Primary Completion
November 1, 2015
Study Completion
August 1, 2016
Last Updated
August 26, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share