Status:
COMPLETED
Glycemic Response of Bean-and-rice Meals in Type 2 Diabetes Mellitus
Lead Sponsor:
Arizona State University
Collaborating Sponsors:
United States Dry Bean Council
Conditions:
Blood Glucose
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-70 years
Phase:
PHASE2
Brief Summary
The study uses a randomized, placebo-controlled experimental design consisting of 4 different test treatments matched on carbohydrate (CHO) content. The three beans are similar in their CHO content am...
Detailed Description
The 4 test treatments will be administered randomly on a different morning, at least one week apart. Participants will be required to consume the entire test treatment meal in 7 minutes while being ob...
Eligibility Criteria
Inclusion
- Eligible subjects will be between the ages of 35 and 75, have a body mass index value (BMI) between 22-40 kg/m2, be physician diagnosed with type 2 diabetes for at least six (6) months and currently controlling their blood glucose levels using dietary methods, exercise and/or through the use of oral hypoglycemic agents such as Metformin for at least three(3)months, and have an HbA1c \<10%.
Exclusion
- Exclusion criteria included: the presence of unresolved health issues (e.g. hypertension not controlled by medication), evidence of condition(s) that would influence the participant's ability to complete the study such as gastrointestinal disease, weight changes of ≥10% of the participants body weight within a 6 month period, women who are either pregnant or breastfeeding, allergy to beans or latex, an HbA1c level \>10% at screening, and the inability to follow study protocol.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01241253
Start Date
November 1 2009
End Date
April 1 2010
Last Update
October 31 2019
Active Locations (1)
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1
Arizona State University, Nutrition Program
Mesa, Arizona, United States, 85212