Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes
1 other identifier
interventional
20
1 country
1
Brief Summary
The aim of this study is to assess the post-prandial response of four breakfast with different content of dietary fiber and glycemic index on glycemic response and satiety in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes-mellitus
Started Mar 2011
Shorter than P25 for not_applicable type-2-diabetes-mellitus
1 active site
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
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 3, 2011
CompletedFirst Posted
Study publicly available on registry
August 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedAugust 5, 2011
August 1, 2011
6 months
August 3, 2011
August 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
glycemic control
glucose and insulin
fasting and post-prandial (differents times during 180 minutes)
Secondary Outcomes (1)
measures of satiety and appetite
fasting and post-prandial (different times for 180 min)
Study Arms (4)
meal D
EXPERIMENTALlow fiber and low GI
meal C
EXPERIMENTALlow Fiber and High GI
meal B
EXPERIMENTALhigh Fiber and low GI
meal A
EXPERIMENTALhigh fiber and high GI meal
Interventions
meals with different fiber content and glycemic index
Eligibility Criteria
You may qualify if:
- type 2 diabetes,
- HbA1c \< 9%,
- BMI \< 35kg/m²,
- Metformin and/or diet as treatment for diabetes
You may not qualify if:
- Use of insulin as diabetes treatment
- digestive disease with malabsorption
- diabetes neuropathy with gastroparesis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (1)
Silva FM, Kramer CK, Crispim D, Azevedo MJ. A high-glycemic index, low-fiber breakfast affects the postprandial plasma glucose, insulin, and ghrelin responses of patients with type 2 diabetes in a randomized clinical trial. J Nutr. 2015 Apr;145(4):736-41. doi: 10.3945/jn.114.195339. Epub 2015 Feb 11.
PMID: 25833777DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Flávia M Silva
Hospital de Clínicas de Porto Alegre
- STUDY CHAIR
Thais Steemburgo
Hospital de Clínicas de Porto Alegre
- STUDY CHAIR
Caroline Kramer
Hospital de Clínicas de Porto Alegre
- STUDY CHAIR
Giovana Menegotto
Hospital de Clínicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 3, 2011
First Posted
August 5, 2011
Study Start
March 1, 2011
Primary Completion
September 1, 2011
Study Completion
January 1, 2012
Last Updated
August 5, 2011
Record last verified: 2011-08