Effect of Nutritional Products on Metabolic Parameters in Subjects With Type 2 Diabetics
1 other identifier
interventional
37
1 country
2
Brief Summary
To compare the postprandial glycemic and insulinemic response of subjects with type 2 diabetes consuming a typical breakfast meal or no breakfast to 10004RF via a meal tolerance test (MTT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 diabetes-mellitus-type-2
Started Aug 2010
Shorter than P25 for phase_2 diabetes-mellitus-type-2
2 active sites
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 27, 2011
CompletedFirst Posted
Study publicly available on registry
March 29, 2011
CompletedMarch 30, 2011
March 1, 2011
1 month
March 27, 2011
March 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Positive AUC for plasma glucose concentration
0 to 180 minutes
Secondary Outcomes (2)
Plasma glucose concentrations
0 to 180 minutes
Positive AUC for serum insulin concentration
0-180 minutes
Study Arms (3)
No breakfast/beverage only
PLACEBO COMPARATOR12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
Breakfast
ACTIVE COMPARATOR1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
10004RF
EXPERIMENTAL1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
Interventions
12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
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
- If subject is on a chronic medication such as an anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, they have been on constant dosage for at least two months prior to screening visit.
You may not qualify if:
- Hemoglobin A1c value at screening of greater than or equal to 9%.
- Uses exogenous insulin or exenatide for glucose control.
- type 1 diabetes.
- history of diabetic ketoacidosis.
- current infection; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit.
- active malignancy
- significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure.
- end-stage organ failure or is status post organ transplant.
- history of renal disease.
- current hepatic disease.
- history of severe gastroparesis.
- chronic, contagious, infectious disease
- taking any herbals, dietary supplements, or medications, other than anti-hyperglycemic medications, that could profoundly affect blood glucose.
- clotting or bleeding disorders
- allergic or intolerant to any ingredient found in the study products.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (2)
Provident Clinical Research and Consulting LLC
Glen Ellyn, Illinois, 60137, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
Related Publications (1)
Lohner S, Kuellenberg de Gaudry D, Toews I, Ferenci T, Meerpohl JJ. Non-nutritive sweeteners for diabetes mellitus. Cochrane Database Syst Rev. 2020 May 25;5(5):CD012885. doi: 10.1002/14651858.CD012885.pub2.
PMID: 32449201DERIVED
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
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 27, 2011
First Posted
March 29, 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