Post Prandial Glucose Control Proof-of-Principle
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to compare the postprandial glycemic response of subjects with type 2 diabetes when consuming a meal along with beverages containing various combinations of nutritional ingredients and fibers versus control beverage.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 diabetes-mellitus-type-2
Started Aug 2010
Shorter than P25 for phase_2 diabetes-mellitus-type-2
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
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 30, 2011
CompletedMarch 30, 2011
March 1, 2011
1 month
March 28, 2011
March 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Positive AUC from 0 to 240 minutes for plasma glucose.
0 to 240 minutes
Secondary Outcomes (1)
Plasma glucose concentrations
0 to 240 minutes
Study Arms (5)
Nutritional ingredient
ACTIVE COMPARATORDissolve in water and consume with meal
Carbohydrate
PLACEBO COMPARATORdissolve in water and consume with meal
#1 Nutrtitional ingredient + Fiber
EXPERIMENTALDissolve in water and consume with meal
#2 Nutritional ingredient + Fiber
EXPERIMENTALDissolve in water and consume with meal
#3 Nutritional ingredient + Fiber
EXPERIMENTALDissolve in water and consume with meal
Interventions
Dissolve in water and consume with meal
Dissolve in water and consume with meal
Dissolve in water and consume with meal
Eligibility Criteria
You may qualify if:
- type 2 diabetes
- between 21 and 75 years of age
- male or a non-pregnant, non-lactating female, at least 6 weeks postpartum or postmenopausal or surgically sterile
- BMI is \> 18.5 kg/m2 and \<35 kg/m2
- HbA1c \< 9.0%
You may not qualify if:
- Subject uses exogenous insulin, exenatide, or sitagliptin phosphate
- type 1 diabetes.
- history of diabetic ketoacidosis.
- current infection
- active malignancy
- has had a significant cardiovascular event or history of congestive heart failure.
- end-stage organ failure or post organ transplant.
- history of renal disease.
- hepatic disease.
- history of gastrointestinal disorders
- chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications
- clotting or bleeding disorders.
- allergic or intolerant to any ingredient found in the study products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (1)
Radiant Research
Cincinnati, Ohio, 45249, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Amy Devitt-Maicher, PhD
Abbott Nutrition
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 28, 2011
First Posted
March 30, 2011
Study Start
August 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
March 30, 2011
Record last verified: 2011-03